PHARMA REGULATORY AFFAIRS 1.

.Introduction Need of regulatory affairs in Clinical research To discover a New drug Treatment Diagnosis Device which is Safe & Effective for human beings Regulatory a air! in P"ar#aceutical indu!try$$$$$$$$$$$$$$$$ Aim - rotection of human health Ensures - Safety! efficacy! "uality of drugs! Accurate drug information #egulates roduction! im$ort! e%$ort! storage! distribution! sale! su$$ly of drugs A$$lied National! international level Effective in few develo$ed countries Needs su$$ort government! $rofessional associations! consumer grou$s! other $ublic interest grou$s %eed o "ar#oni&ation$$$$$$$$$$$$$$$$$$$$$$ revents the com$romisation in the standards of safety and effectiveness of drug& 'el$s in o$timi(ing the "uality of domestic and international mar)ets while facilitating the e%$ansion of international mar)et revents in mar)et circulation of sub-standard drugs Hi!tory$$$$$$$$$$$$$$$$$ Countries li)e Egy$t! Euro$e! *+ faced the $roblems of drug adulterations in medieval $eriod and in first century A&D& which lead to death of humans This lead to raise of drug control and many countries introduced laws Ne%t came the need of new drug develo$ment Drugs with serious side effects started a$$earing in international mar)et, eg&! Thalidomide tragedy Outco#e! ro# t"e "i!tory$$$$$$$$$$$$$$$$ Countries began to ma)e a stringent demands for substantial evidence of safety and efficacy -or new drugs! results of animal tests & research $rotocols for human tests had to be now $rovided before any test on humans could be initiated& Medicine! Act$$$$$$$$$$$$$$$$$$$$$$$$$ ./0.! *+! medicines act came into force leading the $harmaceutical com$anies to ac"uire license from the licensing authority& This further ensured safety! efficacy! "uality of medicines The act also gave the country the legislative $ower to monitor adverse events! control $romotion and advertising! and ins$ect $harmaceutical manufacturing facilities 'HO$$$$$$$$$$$$$$$$$$$$$$$$$ After the establishment of 1'2 in ./34! the $harmaceutical trade concern received international recognition& 1'2 ta)en $art in im$roving "uality of drugs in its member states 5t also $romoted global mechanisms for regulating the "uality of $harmaceutical $roducts in international mar)et

Initiati(e! ta)en *y 'HO$$$$$$$$$$$$$$$$$$$$$$$$ Selection of international $ro$rietary names for $harmaceutical $roducts ublication of international $harmaco$oeia Establishment of 1'2 67 guidelines for $harmaceuticals Creation of 1'2 certificate scheme to ensure the "uality of $harmaceutical $roducts sold on international mar)et Creation of national & regional "uality control laboratories 6uidelines dealing with regulatory & 8A issues were develo$ed and made available to countries rovided su$$ort in setting u$ & strengthening of drug regulatory & 8A issues 'el$ed around 09 countries to enact either new drug legislation! or to amend e%isting drug legislation Efforts were made to have common system of regulations for all countries thereby having a better hold over regulatory re"uirements of the drugs This was first $ut into $ractice by Euro$ean union :E*; +OMMO% TE+H%I+AL ,O+UME%T$$$$$$$$$$$$$$$$$$$$$$$ The Common Technical Document :CTD; is a set of s$ecification for a$$lication dossier for the registration of 7edicines and designed to be used across Euro$e! <a$an & *S& 5t was develo$ed by the Euro$ean 7edicines Agency :E7EA! Euro$e;! the -ood and Drug Administration :-DA! *&S; and the 7inistry of 'ealth! =abour & 1elfare :7'1! <a$an;& The CTD is maintained by the 5nternational conference on harmoni(ation of technical re"uirements for the registration of $harmaceuticals for human use :5C'; The Common Technical Document is divided into five modules> Administrative and $rescribing information 2verview and summary of modules ? to @ 8uality :$harmaceutical documentation; Safety :to%icology studies; Efficacy :clinical studies; The contents of 7odule . and certain subheadings of other 7odules will differ! based on national re"uirements& After the *nited States! Euro$ean *nion and <a$an! the CTD has been ado$ted by several other countries including Canada and Swit(erland& ,RUG REGULATORY AUTHORITY %ET'OR-S$$$$$$$$$$$$$$$$$$$$$$$ The creation of drug regulatory authority networ)s! such as 5nternational conference of drug regulatory agencies African drug regulatory Agencies conference African drug regulatory authorities networ) hel$ed in $romoting coo$eration between national drug regulatory authorities to discuss issues of mutual interest and to facilitate timely e%change of technical information 6eo$olitical grou$s in Asia! Euro$e! =atin America have $romoted 'armoni(ation & mutual recognition of drug regulation at regional! subregional! global level facilitating trade in $harmaceuticals

%EE, FOR ,RUG REGULATIO%S$$$$$$$$$$$$$$$$$$$$$$$$ 5m$ortance of drug in human life made the drug regulations mandatory& 2ther reasons! which favor the need for regulation of drugs are resence of third $arties li)e researchers! manufacturers! distributors! $romoters! dis$ensers etc in between rescriber and atient& 6ood relation between $hysician and $harmaceutical industries or sales re$resentatives which attracts the $hysician to gifts offered rather than having interest on $rescribing good medicines to $atient 5f a $hysician acts both as $rescriber and dis$enser the $otential conflict arises between financial gain to be made from sale of more drugs and $rofessional obligation to advice what is best for $atient 7isuse of drugs & drug shortages can have serious effects on health of individual $atients harmaceutical $roducts have limited shelf life even when stored under s$ecific storage conditions& Thus if they are stored under adverse or im$ro$er conditions they can deteriorate very ra$idly! losing their thera$eutic value& PRESE%T S+E%ERIO OF ,RUG REGULATIO%$$$$$$$$$$$$$$$$$$$$$$$$$$ Since early ./A9Bs! there has been an increasing in $ublic & government interest in safety and efficacy of $harmaceutical $roducts and medical devices& This increase in regulatory re"uirements for $harmaceutical $roducts has dictated that com$anies in these industries establish a distinct de$artment! staffed with $rofessionals to assure in meeting regulatory re"uirements& These individuals are )nown as #egulatory Affairs rofessionals 7edicines e%$orted from industriali(ed countries are not regulated to the same level as those domestically consumed #elabelling of $roducts to mas) details of their origin is also )nown to occur& The $roblem of distributing of drugs via internet also increased& 'ence the maCor concern here would be how to $rotect consumers from substandard & dangerous drugs moving on international mar)ets According to recent wor)ing grou$ s$onsored by 1orld Dan) & attended by re$resentatives of 1'2! *nited Nations childrenBs fund & other organi(ations! the main barriers to effective drug regulation are Absence of $olicy! regulation =ac) of $olitical su$$ort =ac) of finance Corru$tion 5nsufficient human resources Absence of $riorities 1ea) $rofessional association etc HO' TO MA-E ,RUG REGULATIO% MORE EFFE+TI.E/$$$$$$$$$$$$$$$$$$$$$$$$$$$ The sco$e! nature & $ractice of drug regulation including $riorities! standards! resources available vary from country to country& Dut! the main goal is $romotion & $rotection of $ublic health by ensuring safety! efficacy & "uality of drugs& A drug regulatory body should Dase its decisions on scientific evidences

1.

0.

rovide efficient & timely services A$$ly sound management $rinci$les #each its obCectives 2$erate to safeguard against corru$tion Countries desiring to ma)e their drug regulation effective need to ta)e measures described below Assess Drug #egulation erformance 5dentify & Develo$ riority -unctions rovide a Clear 7ission & ur$ose Create a Su$$ortive environment -ormulate Ade"uate Drug =egislation Create A$$ro$riate 2rgani(ational Structure Allocate Ade"uate 'uman & -inancial #esources 7inimi(e Corru$tion A!!e!! ,rug Regulation Per or#ance oor drug regulation leads to $revalence of substandard! harmful! ineffective drugs on national & international mar)et resulting in serious harm to health of consumers& Therefore countries must strengthen their drug regulatory authority to ensure safety! efficacy! "uality of drugs & accurate $roduct information& Countries must assess their drug regulation $erformance! using indicators that focus on structures & in$uts! $rocesses & outcomes They must identify strengths & wea)nesses of their regulatory system & reason for them Consider alternative o$tions & ma)e the most a$$ro$riate & $racticable choices

Identi y 1 de(elo2 2riority unction! The develo$ment of regulatory ca$acity occurs in $hases Develo$ing countries will need to start with limited $riority activities Attem$t made to introduce all regulatory measures & $rocesses at once will lead to failure 6overnment have to set $riorities -or setting $riorities! a regulatory agency must first decide what e%actly it wants to regulate! what activities it wants regulatees to $erform! & how it can ensure they $erform them 3.Pro(ide clear #i!!ion 1 2ur2o!e A clear written mission! based on $riorities & functions! should be $rovided for drug regulation! indicating what it intends to achieve & methodology to achieve it& The core mission of drug regulation for all countries is to $romote $ublic health by ensuring the "uality! safety & efficacy of dugs! & accurate $roduct information! the mission may also include Ensuring timely availability of drugs Encouraging domestic $roduction of drug $roducts 4. +reate a !u22orti(e en(iron#ent

 Effective drug regulation is $romoted if $olitical system assures basic democratic rights by allowing $rofessional associations! consumer unions! $ublic interest grou$s etc Countries with strong consumer unions! $ublic interest grou$s generally have stronger consumer $rotection The history of drug regulation in develo$ed countries shows that im$rovements in "uality of drug regulation have often occurred in res$onse to a drug incidents & resulting $ressure e%erted by $ublic grou$s 5. For#ulate ade6uate drug legi!lation Drug legislation forms the basis of drug regulation Drug legislation must Define areas & activities to be regulated State the roles! res$onsibilities! rights & functions of all $arties involved with drug regulation Create administrative bodies necessary for the im$lementation of drug regulation! and define their structural & functional relationshi$s Set the "ualifications & standards for those handling drugs Establish the administrative measures & legal sanctions that will a$$ly when $rovisions of drug legislations are violated 7. +reate a22ro2riate organi&ational !tructure 5n almost all countries! the res$onsibility for regulating drugs belongs to government 'owever de$ending on national circumstances! the government may delegate certain regulatory activities to the $rivate sectors li)e consumer grou$s! $rofessional associations etc Care should be ta)en to ensure a$$ro$riate distribution of duties! res$onsibilities! functions between different bodies There should be well written terms of reference that describe the lin)ages between the various bodies 8. Allocate ade6uate "u#an 1 inancial re!ource! 6overnments must em$loy $eo$le with s$eciali(ed )nowledge & s)ills if they wish to $romote effective drug regulation& 7oreover! they must em$loy individuals of great integrity & $ay them well! $articularly since drug regulation involves various sta)eholders with commercial interests who will often a$$ly $ressure to secure favourable decisions& 5n $romoting effective drug regulation! ade"uate budgeting is essential 4& 7inimi(e corru$tion Corru$tion is often seen at the intersection of $ublic & $rivate sectors Some a$$roaches to minimi(e corru$tion 7a)ing rules unishing those who ta)e or offer bribes etc THE ,RUG REGULATORY SYSTEM I% I%,IA$$$$$$$$$$$$$$$$$$$$$$$

 5n 5ndia a$$roval or ban of drugs are ta)en care by CDSC2 5t also acts as C=AA :central license a$$roving authority; for Drugs CDSC2 officers are $artici$ating in ? areas of wor) with state Drug #egulatory Authorities officers& They are 5ns$ection of C=AA category units Drawing sam$les for analysis 5ns$ection of manufacturing units for issuing 1'2 67 certificates Role o !tate drug regulatory aut"ority There are ? as$ects which are observed by state D#A #egulate the manufacture of drugs in their area to meet the s$ecifications & guidelines laid down by Drugs & Cosmetics Act! ./39 & #ules! ./3@ To regulate the standards of drugs in the inter & intra state levels To $revent! control & ta)e ste$s to $unish the offenders ,i!2o!al o detected ca!e! Sus$ensionEcancellation of license if offence is detected There are state amendments in Act! which differentiate same crime from . state to another leading to dis$osal of offence T"e !ugge!ted #odi ication! There should be one Act for entire country to control "uality of drugs The act & rules should be im$lemented by . organi(ation *$grading all state drugs testing laboratories & setting u$ electronic networ) for effective functioning under the control of CD= :central drugs laboratories; Designated courts in each region of state may be established +entral drug aut"ority 9+,A: =oo)s after the overall control of drugs moving in the country & directly re$orts to 7 or resident of 5ndia Their decisions affect the health of Nation CDA a$$roves new drugs & directly su$ervises the AD# re$orted They should submit annual re$ort of the "uality of drugs moving into the 5ndian mar)et ;onal drug aut"ority 9;,A: #e$orts to CDA They also acts as licensing authority State drug aut"ority Directly re$orts to NDA under intimation to #DA They are the licensing authority for manufacture of drugs in their state State vigilance officer S& in CD5 with su$$ort staff & facilities to carry criminal investigations

,i!trict drug aut"ority 5& h&S :5ndian $harmaceutical services; or assistant director Su$ervises the $erformance of the drug officers wor)ing in his area Directly re$orts to SDA =icensing authority of all distribution outlets of drugs in the area O icer o drug!< drug! o icer 5n charge of the area allocated & res$onsible for the affairs of that area 'e can register -5# in all criminal cases arising out of the im$lementation of acts on drugs in the concerned $olice station F& ,RUG REGULATORY AUTHORITIES T"e Role o ,rug Regulatory Aut"oritie!$$$$$$$$$$$$$$$$$ Defore new medicines reach the $rescri$tion $ad! the a$$ro$riate regulatory authorities! who assess their safety & efficacy! must a$$rove them first Decause of following incidents 67 6uidelines came into e%istence and became mandatory Eli%ir of Sulfanilamide Tragedy :./?0; Thalidomide Tragedy :./A.; Devon$ort 'os$ital Tragedy :./0F! @ $eo$le died at Devon$ort hos$ital because a batch of infusion solution had not been fully sterili(ed by the $roducer! due to $oor 67 ; 67 guidelines were .st given by statutory authority in *SA! ./AF & in *+! ./0. Now E* 6uide received statutory authority! through an E* directive! in .//. 5t defines 67 as G that $art of "uality assurance which ensures that $roducts are consistently $roduced & controlled to the "uality standards a$$ro$riate to their intended use & as re"uired by their mar)eting authori(ation or $roduct s$ecificationH 5t contains / cha$ters! designed to be a$$licable to all $harmaceutical manufacturing The / cha$ters are .& 8uality management F& ersonnel $remises & e"ui$ment ?& Documentation 3& roduction @& 8uality control A& Contract manufacture & analysis 0& Com$laints 4& roduct recall /& Self ins$ection So#e ,rug Regulatory Aut"oritie! 'orld 'ide$$$$$$$$$$$$$$$$$$$$$ Agencie! o United State! o A#erica$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$ 1. T"e 'orld Healt" Organi&ation 1'2 is the *nited Nations s$eciali(ed agency for 'ealth established on 0 th A$ril! ./34 1'2 main obCective attain highest $ossible level of 'ealth&

 1'2Bs constitution defined 'ealth as Ga state of com$lete $hysical! mental & social wellbeing & not merely the absence of diseaseH 8uality assurance & safety of medicines :8S7; team is res$onsible for develo$ment! harmoni(ation & $romotion of international standards! & for the e%change of information The drug regulatory $rogram su$$orts 7ember states in their regulatory wor) with 1'2 guidelines All Euro$ean countries face new regulatory changes that re"uire international collaboration Drug regulation in countries of E* is covered under the CAD#EAC :collaboration agreement of drug regulatory authorities in Euro$ean *nion associated countries; agreement to discuss $rogressive harmoni(ation with Euro$ean union #egulation 0. Food and ,rug Ad#ini!tration 9F,A: 2ldest & most res$ected consumer $rotection agencies Aim- to $romote & $rotect $ublic health by allowing only safe & effective $roducts reach the mar)et 5t monitors the $roducts for continued safety even after they have been brought into use 5t hel$s the $ublic to get accurate! scientific information needed to im$rove their health -DA $rotects the $ublic from unnecessary e%$osure to radiation from electronic $roducts :microwave ovens! cell $hones! %-ray e"ui$ment! lasers etc; -DA regulates drugs & devices used for animals 7anufacturers can mar)et animal drugs after getting a$$roval from -DA by $roviding $roof of their safety & effectiveness 3. T"e PA% A#erican Healt" Organi&ation 9PAHO: 5nternational $ublic agency with .99 yrs of e%$erience 1or) to im$rove health & living standards of Americans Serves as s$eciali(ed organi(ation for health of 5nter-American system Serves as regional office for American 1'2 Agencie! o U.-$$$$$$$$$$$$$$$$$$$$$$$$$$$$$ 1. %ational in!titute or *iological !tandard! 1 control 9%I=S+: 7ulti-disci$linary scientific establishment ur$ose is to safeguard & enhance $ublic health by standardi(ing & controlling biological substances used in medicine 5nternational role in $re$aring! evaluating! distributing international biological standards 5t is also a 1'2 international laboratory for biological standards 0. Medicine! 1 "ealt"care 2roduct! regulatory agency 9MHRA: E%ecutive agency of de$artment of health rotects & $romotes $ublic health & $atient safety by ensuring that medicines! healthcare $roducts & medical e"ui$ment meet a$$ro$riate standards of safety! "uality! $erformance & effectiveness & are used safely 7ain obCectives 7inimi(e the cost of regulation rovide authoritative & accessible information

 7a)e an effective contribution to $ublic health Su$$ort industry & scientific innovation 5nfluence international regulation Au!tralian Regulatory Agencie! T"era2eutic Good! Ad#ini!tration 9TGA: *nit of Australian 6overnment De$artment of 'ealth erforms assessment & monitoring activities to ensure thera$eutic goods available in Australia are of an acce$table standard 2bCective of T6A! ./4/ is to $rovide national framewor) for regulation of thera$eutic goods in Australia & ensure their "uality! safety & efficacy Any $roduct for which thera$eutic claims are made must be entered in the Australian register of Thera$eutic goods :A#T6; before the $roduct can be su$$lied in Australia T6A regulations are on a number of factors including advertising! labeling! $roduct a$$earance & a$$eal Pre$#ar)et a!!e!!#ent roducts assessed as having higherElower level of ris) are evaluated for safety! efficacy! "uality 2nce a$$roved for mar)eting! $roducts are included in A#T6 as IregisteredB $roducts & are identified by A*ST #E= number Licen!ing o #anu acturer! Australian manufacturers of thera$eutic goods must be licensed Their manufacturing $rocesses must com$ly with 67 $rinci$les Po!t #ar)eting (igilance 5ncludes investigating re$orts of $roblems! laboratory testing of $roducts! monitoring to ensure com$liance with legislation Iri!" 2olicie! Iri!" Medicine! =oard 9IM=: To ensure current medical & scientific )nowledge! "uality! safety! efficacy of medicines available in 5reland 57D $rovides the a$$roval for use of medicine! monitors the ty$e & fre"uency of any re$orted side effects 57D monitors the "uality of medicines by conducting ins$ections at sites of manufacture & distribution of medicines 5n case of veterinary medicines also there must be assurance of "uality! safety! efficacy 57D carries out the following services within 5reland =icensing of medicinal $roducts for human use =icensing of veterinary $roducts =icensing of manufacturers of human & veterinary medicines harmacovigilance & drug safety monitoring Clinical trial licensing 5ns$ection of wholesale & manufacturing sites Regulatory Aut"ority in >a2an P"ar#aceutical! 1 #edical de(ice! e(aluation center Established in .//0 to strengthen governmentBs evaluation ca$acity for securing safety & $reventing harmful side effects of $harmaceuticals

 Evaluates "uality! safety! efficacy of each $rescri$tion drugs & medical devices as well as $ro$rietary drugs! cosmetics that are $urchased directly by $ublic Proce!! or t"e a22ro(al o ne?ly de(elo2ed drug A$$licant must a$$ly to ministry of health! labour & welfare :7'1; with the data 7'1 leaves the data reliability survey to e%ternal institution after evaluation by different officials with different bac) ground The re$ort is submitted to $harmaceutical affairs & food sanction council : A-SC;! which is a consultative body of minister Dased on this re$ort the ministry finali(es the whether they should a$$rove the drug or not& Regulatory Aut"ority in Re2u*lic o Lat(ia Non $rofit state Coint stoc) com$any !tate agency o #edicine! 9 SAM : -ounded on /th 2ct! .//A SA7 acts in accordance with harmacy law =aw of Coint stoc) com$anies =aw of non $rofit organi(ations 2ther regulatories Regulatory Aut"ority in +anada Healt" Product! 1 Food =ranc" 9HPF=: 5ntegrated a$$roach to the management of ris)s & benefits related to health $roducts & food by 7inimi(ing health ris) factors to Canadians while ma%imi(ing the safety romoting conditions that enable Canadians to ma)e healthy choices & $roviding information so that they can ma)e informed decisions about their health ' -D ins$ectorate is res$onsible for management of ins$ection! investigation! monitoring activities related to fabrication! $ac)ing! labeling! testing! im$ort! distribution of regulated health $roducts for human & animal use Mar)eted Healt" Product! ,irectorate 9MHP,: #es$onsible for coordination of consistency of $ost a$$roval surveillance & assessment of safety trends concerning all mar)eted health $roducts 1or)s in collaboration with other directorates in 'ealth roducts & -ood Dranch & with other involved branches 7' D Activities 7onitors & collects AD# data Conducts ris)s E benefit assessment Communicates $roduct related ris)s to healthcare $rofessionals & $ublic Conducts active surveillance & drug effective $roCects %atural Healt" Product! SE8 of 'ealth $roducts O ice o %utrition 2olicy 1 2lanning $romotion & $rotection of activities related to nutrition

 O ice o A!!i!tant ,e2uty Mini!ter to im$rove efficiency & effectiveness of functions Regional o2eration! ' -D activities are carried out through offices in the national ca$ital region & regional offices :Atlantic region! 8uebec! etc; Regulatory Agency in Slo(a)ia State in!titute or drug control 9SI,+: 5n Dratislava 5s the institution of 7inistry of 'ealth of Slova) re$ublic res$onsible for ensuring surveillance of "uality! efficacy! safety of medicinal $roducts for human use S5DC #es$onsibilities Controls! standardi(es! evaluates the $rocess of assessing 8!E!S of drugs erforms ins$ections of 67 ! 6= ! 6C ! 6ood harmacy $ractice +ee$s database of registered drugs & medical devices erforms vigilance in the field of medical devices Acts in field of training & education Statu! o ,rug Regulation in !o#e +ountrie!$$$$$$$$$$$$$$$$$$$$$$$$$$ 'HO A rican Region A survey conducted during .//F-/? using a "uestionnaire to assess e%istence of 8A systems in 1'2 African #egion found that 2ut of FA countries .. has 8A system :including 8C lab;but it was not functioning well / had some )ind 8A system without 8C lab A did not have any 8A system ./ countries mentioned illegal im$ortation as a serious $roblem 2f F. countries with domestic $harmaceutical manufacturing! A did not have 8C lab & 3 are without an ins$ectorate Lao 2eo2le@! de#ocratic re2u*lic Defore ./44 all drugs were distributed by $ublic sector At $resent! there are A manufacturing $lants! ?F $rivate im$orters & F9.4 $rivate $harmacists Food 1 ,rug ,e2art#ent 9F,,: is res$onsible for registration of drugs! ins$ection & licensing of manufacturers 5t is also res$onsible for $ublic sector drug su$$ly! control of narcotic drugs & $sychotro$ic substances Food 1 ,rug Auality +ontrol +enter 9F,A++:B .//@& underta)es chemical analysis of drugs -enya +enya has . $ublic sector drug $rocurement agency! .?@ $rivate im$orters & wholesalers! 39 $harmaceutical com$anies The legal instructions for regulating drugs are harmacy & oisons Act!./@0 harmacy & oisons #ules! ./4. a$$ly to registration of Drugs harmacy & oisons Doard established under harmacy & 7edicines Act! is res$onsible for registration of $harmacy $rofessionals! mar)et authori(ation of drugs! issuing licenses to manufacturer! wholesaler! retail $harmacies

 A national drug control laboratory was established in .//@ under $harmacy & $oisons Doard& 5t carries out limited $re & $ost mar)eting 8C of drugs The ins$ectorate! under the director of medical servicesE ministry of health! underta)es surveillance of wholesale & retail outlets Drugs are being smuggled into country 1'2 certificate scheme is not a$$lied as recommended by 1'2 when assessing status of drugs +enya e%$orts drugs to other African countries by issuing Gfree saleH certificates even though it has no ins$ectorate to assess 67 com$liance Myan#ar ? authorities are res$onsible for drug regulation .& The 7yanmar -ood & Drug Doard Authority F& -ood & Drug Su$ervisory Committee :-DSC; ?& -DA -DSC issues licenses & ins$ects drug wholesalers! retailers -DA issues mar)eting authori(ation! ins$ects manufacturing $lants & tests the "uality of drugs Drug Advisory Committee :DAC;- a$$lications are reviewed for mar)et authori(ation! $ost mar)eting surveillance .ietna# .ietna#@! Mini!try o Healt" Acts as Drug regulatory authority and manages state owned Drug manufactures! im$orts & e%$orts -DA res$onsible for formulation! drug legislation! registering drugs! issuing licenses etc Drugs are being smuggled in & out of vietnam +olo#*ia +olo#*ia@! ,rug Regulatory Agency 9,RA: #es$onsibilities Controlling "uality & safety of medicines! biological $roducts! foods! cosmetics! medical devices 5ssuing licenses concerning manufacture of medicines 5ssuing mar)eting authori(ations Pa)i!tan Pa)i!tan@! drug actB 1C87 =icensing of manufacturing $lants! im$orting & e%$orting & registration of medicines to federal government At federal level! Central licensing & registration body consists of -ederal director general Drug controller $rovincial director general of health Central board of revenue & Custice division! medical & $harmaceutical e%$erts All are res$onsible for regulating! manufacturing! registering! im$orts! e%$orts of drugs 3.REGULATIO%S O% ALTER%ATI.E SYSTEM OF ME,I+I%E

%EE, FOR REGULATIO%S O% ALTER%ATI.E SYSTEM OF ME,I+I%E$$$$$$$$$$$$$$ 5ndia is a land of different origin for a number of systems of medicine li)e Ayurveda & *nani As there are no s$ecial rules enforced on manufacture of Ayurveda medicines! it resulted in s$oiling the "uality of medicines Drugs & Cosmetics Act! ./39 was valid only to Allo$athic medicines Dut later in ./0A Ayurvedic medicines were also included 1ith the announcement of 67 norms for alternative medicine! the Ayurvedic medicines manufacturers are now liable to follow 8C measures which were intended only for Allo$athic medicines till now I%,IA% ME,I+I%E +E%TRAL +OU%+IL A+TB 1C8D$$$$$$$$$$$$$$$ To $rovide for the establishment of a Central Council of 5ndian 7edicine 7aintenance of a Central #egister of 5ndian 7edicine 5ndian 7edicine the system of 5ndian medicine commonly )nown as Ashtang Ayurveda! Siddha or *nani Tibb .& The central council & its committees >7embers not e%ceeding @ from each state& resident! vice $resident elected among them selves& 7eets at least once $er year& 'olds office for a term of @ yrs& Decisions regarding Ayurveda! siddha! unani system of medicines& F& #ecognition of medical "ualification >7edical "ualifications granted by any university etc are recogni(ed& 7edical "ualifications granted by institutions outside 5ndia are also recogni(ed& Ac"uires information about university etc which $rovides medical "ualification& A$$oints visitors for ins$ection of medical colleges! hos$itals etc& council withdraws recognition if the institute does not meet standards& ?& Central register of 5ndian medicine >ractitioners #egister maintained by central council in se$arate $arts for each system of medicine& 5t contains names of candidates enrolled in state register of 5ndian medicine& #egistrar of central council maintains the central registrar & u$dates it by receiving co$ies of state register of 5ndian medicine& ersons who are enrolled on central register of 5ndian medicine are eligible to $ractice medicine in any $art of 5ndia Regulation! in regard to Indian #edicine central council ActB 1C8D$$$$$$$$$$$$$$$$$$ 7anner of election of $resident! vice-$resident! their $owersJ resignation of members A$$ointment! $owers! duties & $rocedures of ins$ectors & visitors Standards of staff! e"ui$ment! accommodation! training & other facilities for education in 5ndian medicine Conduct of $rofessional e%amination! "ualifications of e%aminers etc articulars to be stated & $roof of "ualifications to be given in a$$lications for registration -ees to be $aid on a$$lications & a$$eals GMP FOR AYUR.E,AB SI,,HAB U%A%I ME,I+I%E$$$$$$$$$$$$$$$$$$$$$$$$ 67 are $rescribed to ensure that #aw materials used in manufacture of drugs are authentic of $rescribed "uality& -ree from contamination 7anufacturing $rocess is as $rescribed! to maintain standards

 Ade"uate 8C measures are ado$ted 7anufactured drug! which is released for sale! is of acce$table "uality GMP 9!c"edule$ M:$$$$$$$$$$$$$$$$$$$$$$$$ -ACT2#K #E75SES The manufacturing $lant should have ade"uate s$ace for #eceiving raw material Storing raw material 7anufacturing $rocess area 8C section -inished goods store #eCected goodsE drugs store office General re6uire#ent!$$$$$$$$$$$$$$$$$$$$$$$$$ =ocation & surroundings avoid contamination from o$en sewage! drain etc which $roduces disagreeable odor! fumes! smo)e etc Duildings $remises used for manufacturing! $rocessing! $ac)aging! labeling will be in conformity with $rovisions of -actory Act 1ater su$$ly $ure water must be used& Dis$osal of waste waste water & residues are dis$osed off after suitable treatment as $er guidelines of $ollution control authorities to render them harmless ContainerBs cleaning ade"uate arrangements se$arated from manufacturing o$erations for washing! cleaning! drying of containers Stores ade"uate s$ace for storage of different ty$es of material! such as raw material! $ac)aging material & finished $roducts #aw materials care must be ta)en to handle different )inds of raw materials& Each container used for raw material storage shall be $ro$erly identified with label clearly stating the status :a$$roved& *nder test! reCected;& #aw materials shall be sam$led & tested either by in house or laboratories by government& #ecords of recei$t! testing! a$$roval! reCection shall be maintained ac)aging materials containers! closures shall be cleaned & dried before $ac)ing $roducts -inished goods stores finished goods are stored within an area mar)ed G"uarantineH& 2nly a$$roved finished goods after 8C tests will be dis$atched& Distribution records shall be maintained& 1or)ing s$ace ade"uate $lace to facilitate easy& safe wor)ing and to minimi(e ris) of mi%-u$! cross contamination etc 'ealth! clothing! sanitation & hygiene of wor)ers 7edical services ade"uate facilities for first aid& 7edical e%amination of wor)ers $eriodically E"ui$ment based on si(e of o$eration! nature of $roduct manufactured suitable e"ui$ment shall be made available& S2 for cleaning! maintaining etc of machine shall be laid down Datch manufacturing records :D7#; the licensee shall maintain D7# to $rovide an account of list of raw materials! "uantities obtained! chemical tests $erformed etc& it is essential to maintain records for each & every $rocess

 Distribution of records records of sale & distribution of drugs shall be maintained in order to facilitate $rom$t & com$lete recall of batch #ecord of mar)et com$laints once in A months manufacturer shall submit record of com$laints to licensing authority& The register shall also be available for ins$ection& Adverse reactions re$orted on the $roduct shall also be recoded T"e 6uality control !ection !"all carry out t"e ollo?ing unction! The section should be $rovided with an area of .@9 s"& feet Sam$les should be maintained for identification of raw drugs & for reference 7anufacturing record should be maintained for the various $rocesses carried out during manufacturing Su$ervise & monitor ade"uacy of conditions under which raw materials! semi finished $roducts & finished $roducts are stored +ee$ records of shelf life &storage re"uirements for drugs All raw materials will be monitored for fungal! bacterial contamination with a view to minimi(e such contamination The standards for identity! $urity & strength as given in res$ective $harmaco$oeias of Ayurveda! Siddha & *nani systems of medicines $ublished by government of 5ndia shall be com$lied Re6uire#ent or !terile 2roduct!$$$$$$$$$$$$$$$$$$$$ .& 7anufacturing area -or manufacture of sterile ayurvedic! siddha! unani drugs se$arate enclosed area :dust free! $ro$erly ventilated; shall be $rovided& 'E A filters are to be used& 7anufacturing areas shall be restricted to minimum number of authori(ed $ersonnel F& recautions against contamination and mi% rovide a suitable e%haust system Carry out manufacturing o$erations in a se$arate bloc) of ade"uately isolated building E%$ert technical staff a$$roved by licensing authority shall chec) the yield #oom relative humidity! volume filled! lea)age & clarity should be chec)ed & recorded THE GLO=AL AYUR.E,I+ PRO,U+T MAR-ET$$$$$$ The global Ayurvedic mar)et is booming& The re$orted growth rate is /-.9 L $er annum The herbal drugs in 5ndia is $resently estimated to be around F!?99 crores with a .@L growthEannum Since! the rise of Ayurvedic medicines +erala is fast becoming a uni"ue selling $ro$osition :*S ; to earn for e%change for the country An 5ndian system of 7edicine & 'omeo$athy drug $olicy is currently establishing A medicinal $lant board & 67 authority is re$ortedly being constituted to im$lement good manufacturing $ractices Regulation relating to Ho#eo2at"ic #edicine$$$$$$$$$$$$$$$$$$$$ Since early .//9s! number of changes in status of homeo$athic remedies have ta)en $lace&

 Numerous remedies that were once sold as 2TC drugs have been moved into $rescri$tion status This is due to $ublication of -DA! 'omeo$athic $harmaco$oeias of *nited states :' *S; T"e Ho#eo2at"y central council actB1C83 7aintenance of a central register of 'omeo$athy The central council & its committees #ecognition of medical "ualifications Central register of 'omeo$athy T"e central council 1 it! co##ittee! E$ 7embers not e%ceeding @ from each state& resident! vice $resident elected among them selves& 7eets at least once $er year& 'olds office for a term of @ yrs& Decisions regarding 'omeo$athic system of medicines& Recognition o #edical 6uali ication E$ 8ualifications granted by any university etc are recogni(ed& 8ualifications granted by institutions outside 5ndia are also recogni(ed& Ac"uires information about university etc which $rovides medical "ualification& A$$oints visitors for ins$ection of medical colleges! hos$itals etc& council withdraws recognition if the institute does not meet standards& +entral regi!ter o Ho#eo2at"yE$ ractitioners #egister maintained by central council for 'omeo$athic system 5t contains names of candidates enrolled in state register of 5ndian medicine& #egistrar of central council maintains the central registrar & u$dates it by receiving co$ies of state register of 5ndian medicine& ersons who are enrolled on central register of 5ndian medicine are eligible to $ractice medicine in any $art of 5ndia 4.,RUG POLI+Y I% I%,IA 7ain obCectives of Drug olicy! ./4A--------------------- To ensure abundant availability! at reasonable $rices of essential & life saving medicines of good "uality To strengthen the system of "uality control over drug $roduction & $romoting rational use of drugs in country To create an environment for new investment into $harmaceutical industry To encourage cost effective $roduction & to introduce new technologies & new drugs To strengthen the $roduction of drugs The $olicy was im$lemented through 5ndustries act and Drugs $rice control order 5m$lementation of the drug $olicy $rovisions has been through 5ndustries:develo$ment & regulation; act M5:D&#;ActN on industrial licensing as$ects & through Drugs $rice control order :D C2; act

 Enforcement of "uality & standards in medicines is done through the $rovisions contained in Drugs & Cosmetics Act! which is administered by 7inistry of 'ealth & -amily 1elfare! 6overnment of 5ndia The drug $olicy has also given the $olicy framewor) with regard to 8uality Control & rational use of drugs Pre!ent !tatu! 1 a22roac" ado2ted 2ver last 0 yrs! $olicy have been directed towards $romoting growth of industry& As on date there F@9 large units & 4999 small units in o$eration! which form the core of the country These units $roduce the com$lete range of formulations i&e&! medicines ready for consum$tion by $atients! ?@9 bul) drugs etc 5t is estimated that 09L of demand for bul) drugs & almost the entire demand for formulations are being met through domestic $roduction 5n 5ndia! during the last decade the $roduction of bul) drugs has grown from #s&F39 crores in ./49-4. to #s&.?F9 crores in .//?-/3 & corres$ondence increase in $roduction of formulations i&e&! #s .F99 crores to #sA/99 crores Since ./4A! the drug industry has grown significantly! in terms of $roduction of bul) drugs & formulations 5t is estimated that in case of bul) drug $roduction the contribution of small scale is a$$ro%imately ?9L of the total $roduction in 5ndia Indu!trial licen!ing 5m$ort & economic $olicies have undergone maCor changes li)e $runing of negative list for im$orts! doing away with the Actual user condition & full convertibility of #u$ee on trade mar)et 5n this changed scenario! it is felt that there is no need to be more restrictive than before in granting industrial a$$rovals! $rovided the F main concerns i&e&! Achieving basic stage manufacturing Discouraging undue im$orts 5t is also felt that! li)e in other sectors of economy! $roduction would get necessary im$ortance to meet any future demands as well as of ensuring ade"uate availability of drugs at reasonable $rices with more liberali(ation in granting industrial a$$roval R 1 ,B In(e!t#ent 1 Pricing$$$$$$$$$$$$$$$$$$ The drug industry is highly # & D oriented which needs to ensure that technologies used in country are cost effective & efficient& 5nvestment is necessary in order to u$date the e%isting technologies Dasic research in drug sector has assumed greater im$ortance 5n order to meet the growing needs of country! to $romote e%$orts! it is $ro$osed to treat entire drugs & $harmaceutical sector as a high $riority industry for the $ur$ose of $ermitting foreign investment in terms of %e? Indu!try Policy. The high turn over of a drug is an inde% of its e%tent of usage To encourage the $roduction & availability of the drugs! it is considered to allow a uniform 7A E :7a%imum allowable $ost-manufacturing e%$enses; in all cases of drugs

 The government has set u$ an inde$endent body of e%$erts! called %ational P"ar#aceutical Pricing Aut"ority! to do the wor) of $rice fi%ation for drugs& This body would also monitor the $rices of decontrolled drugs & formulations & oversee the im$lementation of $rovisions of ,rug! Price +ontrol Order 6overnment will )ee$ a close watch on $rices of medicines! which are ta)en out of $rice control& 5n case! the $rices of the medicines rise unreasonably! the government would ta)e necessary actions Auality control 1 rational u!e o drug$$$$$$$$$$$$$$$$ 8uality control & rational use of drugs are im$ortant as$ects of $harmaceutical industry Ste$s have been ta)en in strengthening the Drug Control 2rgani(ation by establishing Sub-Oonal offices at 'yderabad! Ahmedabad! atna& The Dio-=aboratory at 7adras has been u$graded to level of National =aboratory Central Drugs =aboratory 7umbai #egional =aboratories 6uwahati! Chandigarh! 'yderabad -or certain Drugs li)e =arge volume arenterals Sera & vaccines 1hole human blood & Dlood $roducts 1hich has found to caused Adverse effects due to lac) of drug control in or other state! the central government has ta)en u$on itself the res$onsibility of granting license 67 has made mandatory Screening of irrational & harmful drugs are done Definition of new drugs has been widened & guidelines issued on clinical trials Adverse Drug #eaction 7onitoring Centers =eading hos$itals at ondicherry! Chandigarh! New Delhi! Dombay! =uc)now %ational ,rug Aut"ority F re!2on!i*ilitie! Develo$ & define basic standards relating to 7anufacture! 5m$ort! Su$$ly & *se of drugs To a$$rove & register $harmaceutical $roducts for use in the country only if 5t meets real medical need 5t is thera$eutically effective 5t is acce$table safe To enforce effectively a$$ro$riate "uality standards of medicines & 67 throughout the country To monitor The standard $ractices in drug $romotion The $rescribing $ractices To ensure that a$$ro$riate information about registered $harmaceuticals is made available for the guidance of consumers in regard to Adverse conse"uences of non-com$laince by $atients $articularly in case of antibiotics! steroids etc Dangers of self-medication

 Need to involve consumers as full $artners in the healthcare system & to $ublish national formularies for the guidance of consumers & doctors Function! S$ecial focus on e%amining the technology of bul) drugs Assessing suitability of man$ower for bul) drug $roduction Develo$ing testing labs for cosmetics! diagnostics & devices =aying down standards for veterinary drugs 8uality control of herbal medicines *$dating new drug a$$roval $rocess -ormation of e%$ert committees for e%amination of new drugs E%amination of labels 5n addition! Screening $romotional literature 7onitoring ongoing clinical trials through 5#D *nearthing substandard & s$urious drugs with the hel$ of legal cum intelligence cells Centrali(ing all manufacturing licensees *$dating 67 s Setting u$ of new analytical testing labs etc were also $erformed by National Drug Authority There is an im$erative need to underta)e u$ gradation of drug testing facilities under the central & state organi(ations Therefore! there is a need for establishing more Oonal & Sub-(onal offices under CDSC2 as well as regional testing laboratories A coordination committee consisting of secretaries of ministriesE de$artments of commerce! revenue! health! biotechnology! industrial develo$ment & chairman! bureau of industrial costs & $rices is been set u$ under the chairmanshi$ of secretary :chemicals & $etro chemicals; for monitoring the )ey concerns on time & for ta)ing timely action Foreign In(e!t#ent$$$$$$$$$$$$$$$$$$$$ -oreign investment u$ to @.L is $ermitted in the case of all Dul) drugs! their intermediates & formulations 5nvestment of above @.L will be considered on a case by case basis in areas where investment is otherwise not forthcoming! $articularly in the manufacturing of bul) drugs Automatic a$$roval for foreign technology agreements are also given in the case of all bul) drugs! their intermediates & formulations e%ce$t those $roduced by the recombinant DNA technology 4. REGULATORY AFFAIRS PROFESSIO% The $harmaceutical industry is the most highly regulated industry demanding a high level of information be submitted to government before a $harmaceutical $roduct is being brought to the mar)et $lace #egulatory affairs is res$onsible for obtaining & maintaining licenses to mar)et medicinal $roducts in as many countries as necessary According to the $resent laws all organi(ations involved in the develo$ment & mar)eting of medicinal $roducts is legally re"uired to have some form of regulatory su$$ort

7any $eo$le move into #egulatory Affairs from laboratory research! clinical research! regulatory com$liance! 8C! 8A or drug safety

8ualification re"uired 7inimum a life science or $harmacy degree 7any technical com$anies re"uire $ost-graduate "ualification! $harmacy! chemistry! biology degrees E%$erience .-F yrs of e%$ in $harmaceutical industry in a related area #egulatory affairs $rofessionals have o$$ortunities to wor) scientifically or commercially! nationally or internationally & many regulatory $rofessionals will at sometime or another e%$erience travel in their role #oles & res$onsibilities of regulatory affairs $rofessionals vary de$ending on the com$any So#e o t"e o22ortunitie! in Regulatory a air! are Tas) s$ecialist s$eciali(es in . area of regulatory affairs Eg J document management! $roduct labeling etc #egulatory s$ecialist wor)s as $harmacist or chemist with s$eciali(ation in $re$aring & managing a s$ecific element of $roduct registration roCect manager the $rofessional manages all the regulatory as$ects of a $roduct develo$ment & maintenance Thera$eutic s$ecialist manages regulatory affairs for $roducts in s$ecific thera$eutic area from formulation stage to license maintenance Eg J oncology! cardio vascular =ine manager $rofessional moves into managing $ower Service $rovider wor) with different com$anies on numerous $roCects 6raduates may enter into a role as #egulatory affairs officer or scientist or e%ecutive This could be in any number of areas li)e clinical research! manufacturing! sales! mar)eting #egulatory affairs $rofession $rovides in an de$th overview of full s$ectrum of drug develo$ment! from clinical trials! mar)eting to $ost-a$$roval activities As members of the drug develo$ment team! regulatory affairs $rofessionals $lay a very im$ortant role in new drug a$$rovals ,e(elo2#ent o t"e 2ro e!!ion #egulatory affairs is a new $rofession which is develo$ed from the desire of government to $rotect $ublic health! by controlling the safety & efficacy of $roducts The regulatory affairs $rofession develo$ed in almost all countries of the world 6overnments have res$onded to $ublic concern over $ublic health & $roduct safety in a number of area by $lacing re"uirements on manufacturers to confirm to stringent safety testing $rocedures & obtain mar)eting authori(ations before $lacing a $roduct in the mar)et The com$anies res$onsible for discovery! testing! manufacture of the $roducts also want to ensure that they su$$ly $roducts that are safe The #egulatory Affairs $rofessionalBs Cob is to )ee$ trac) of the ever changing legislation in all regions in which the com$any wishes to distribute its $roducts

5n order for a regulatory authority to issue a mar)eting authori(ation! it must carryout a close scrutiny of all re$orts generated during develo$ment of $roduct! review the manufacturing methods! 8C $rocedures! clinical safety & efficacy This activity is )nown as assessment #egulatory affairs $rofession is becoming increasingly influential in the overall drug develo$ment $rocess & increasingly $o$ulated by highly trained scientists & medical $rofessionals Re!2on!i*ilitie! o Regulatory A air! Pro e!!ional! The regulatory affairs de$artment is the first $oint of contact between government authorities & com$any #egulatory affairs $rofessionals hel$s to ensure that the $roduct develo$ment! manufacturing & mar)eting $ractices meet or e%ceed government re"uirements #egulatory affairs $rogram $rovides graduates with the s$eciali(ed )nowledge re"uired to hel$ biotechnology! medical device! $harmaceutical & food com$anies manage regulatory $rocesses Students will gain )nowledge of international healthcare system! healthcare legislation! $rocedures & $ractices for regulating the develo$ment! manufacture! 8A & manufacturing of healthcare $roducts #egulatory affairs $rogram have an international focus for the following reasons 7ost com$anies develo$ $roducts for an international mar)et Current regulatory $rocesses in most countries are based on international guidelines #egulatory affairs $rofessionals must ensure that the $roduct information submitted to the authorities is as com$lete as $ossible & in the correct form They are also res$onsible for subse"uent contacts with the regulatory authorities Since authori(ations are issued for a s$ecified time! & have to be renewed before e%$iry! a very im$ortant $art of regulatory affairs function is maintenance & u$dating of authori(ations #egulatory $rofessionals will critically review all the scientific evidence $resented by the com$any to establish the $roductBs "uality! safety! efficacy #egulatory affairs e%ecutive has the res$onsibility to communicate with all $eo$le within the $harmaceutical com$any! e%ternal communicants! medics who have an in$ut to all the data that is $ut together for the regulatory authorities The regulatory affairs $rofessionals will then communicate this information to the government regulatory authorities worldwide in the for of Dossiers #egulatory affairs $rofessionals should be involved at initial synthesis stages! $reclinical stages! clinical stages & all the way through drug develo$ment lifecycle & beyond into $roduct mar)eting cycle The whole $rocess of drug discovery & ultimate release into mar)et may ta)e u$ to .@yrs & many $roblems may arise during this $eriod of scientific develo$ment 5t is the Cob of the regulatory affairs $rofessional to hel$ the com$any avoid deficiencies in their data! which may create difficulties in the registration of the $roduct

5n

#egulatory affairs e%ecutive has to collect all the documented data! )ee$ the documents in the correct & s$ecified order! summari(e where necessary! chec) the validity & ma)e sure there are no conflicts among the data su$$lied #egulatory authorities will generally see) clarification & as) s$ecific scientific "uestions from regulatory $rofessionals on the areas of 8uality! Safety! Efficacy & they will re"uire $rom$t & accurate answer for giving license to $roduct After the com$any got license to manufacture & sell new $harmaceutical $roduct in the chosen mar)et there is a need to maintain & renew the license which is the duty of regulatory affairs $rofessional S)ills! which regulatory affairs $rofessional must have are +ey negotiation s)ills roCect management s)ills 5nformation technology s)ills 7anagement s)ills 5nter$ersonal s)ills All these s)ills are set against a bac)ground of ever changing $harmaceutical regulations world wide clinical trials! #egulatory affairs $rofessionals have the following role to $lay rovide strategic leadershi$ for the develo$ment & e%ecution of regulatory $lans to su$$ort a global drug develo$ment $lan rovide the com$any with regulatory intelligence & e%$ertise in translating regulatory re"uirements into $ractical! wor)able $lans 7anage the daily activities of $ersonnel res$onsible for regulatory submissions! train! mentor & coach regulatory $ersonnel Ensure timely $re$aration of organi(ed & scientifically valid submissions of 5ND etc #e$resent regulatory affairs to other de$artments & $rovide guidance on adherence to regulatory guidelines for effective submissions Assure adherence & com$liance with all a$$licable -DAE5C' guidelines & with current 6= !67 & 6C guidelines Set obCectives for training sessions! standard $ractices! S2 BS & de$artmental $olicies #es$onsible for su$$orting the 6C com$liance $rogram by conducting com$rehension audits of clinical investigator sites resentation of 6C training to other staff rovide su$$ort to internal & e%ternal 6C com$liance $rogram lanning! scheduling! conducting! coordinating investigator sites according to S2 ! a$$licable regulatory re"uirements Assisting in $erforming internal systems audits! reviewing clinical documents As a $roduct goes through the review $rocess! regulatory affairs $rofessionals are loo)ing at re"uirements for manufacturing! $ac)aging & advertising 7anufacturing is related with 8A! 8C ac)aging! labeling & advertising will also interfere with manufacturing There are stringent regulations everywhere that govern these s$heres #egulatory affairs $ersonnel wor) with distribution & ma)e sure the $rocesses meet regulatory re"uirements

2nce the $roduct is in use! regulatory affairs $rofessional is also involved in re$orting any adverse effects of a drug to -DA AUALIFI+ATIO%SB S-ILLS 1 A=ILITIES OF REGULATORY AFFAIRS PROFESSIO%AL 7inimum re"uirement for an individual to enter into regulatory affairs $rofession is to have a scientific bac)ground in order to have the )nowledge to as) the scientists the right "uestions in the light of a vast "uantity of $roduct data! $harmaceutical legislation & guidelines 'aving some wor)ing )nowledge of the industry is always $referable The usual re"uirement is a degree in life science! $harmacy or medical degree with some e%$erience in $harmaceutical Ebiotech industry S)ill! Re6uired 6ood 1ritten S)ills Perbal communication s)ills roblem solving abilities CriticalEanalytical thin)ing s)ills Ability to $lan & manage multi$le $roCects 7eeting deadlines Accommodate changing $riorities Assignments roficiency in com$uter a$$lications 5nter$ersonal s)ills to interact with other de$artments effectively 5n the $harmaceutical industry! regulatory affairs $rofessionals should have e%$ertise in the legal & regulatory environments! as well as in clinical research $rotocols They are the $rimary inter$reters of the laws & regulations for other members of the com$any li)e # & D! manufacturing etc #egulatory affairs $rofessionals must have a thorough understanding of the com$le% set of regulations +ee$ing u$ to date on regulations is essential in regulatory affairsJ changes in regulations can affect the clinical trials $rocess! regulatory strategy! what )inds of decisions are needed on trials etc According to some critics the field of regulatory affairs has become increasingly more science & issue based As the s$eed of $harmaceutical & biologics develo$ment has increased science has become more com$le% A regulatory $rofessional now s$end more time on substantive scientific & medical issues & $lanning for e%$eriments & clinical studies to achieve a$$roval A regulatory affairs $rofessional has to be able to $rovide e%$ert o$inions on technical & legal matters associated with registration of $roducts #egulatory $rofessionals must always e%ercise considerable integrity & Cudgment in the $ractice of their role THE RELATIO%SHIP OF REGULATORY AFFAIRS PROFESSIO%S TO OTHER PROFESSIO%S #egulatory affairs $rofessional must have ca$acity to draw u$on the information $rovided by s$ecialists :$harmacologists! to%icologists! chemists! $harmacists! doctors etc; & must be able to synthesi(e the )nowledge & use it to im$art information & ma)e aware of staff about current regulatory guidelines

As regulatory $rocesses increase in com$le%ity & sco$e! globali(ation occurs within this field! there will be continuing industry demand for $eo$le with a strong foundation in regulatory affairs Communication & organi(ational s)ills are also e%tremely im$ortant in dealing with government agencies Advantages of certification #egulatory affairs certification enhances em$loyment $ros$ects 7any com$anies! both large & small are now beginning to indicate that #egulatory Affairs certificate is a desirable "ualification Certified $rofessionals will earn @-.@L more salary than others