E M E A

introduction
From 1995 to 2004, the European

Medicines Agency was known as

European Agency for the Evaluation of Medicinal Products EMA was set up in 1995 with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, in an attempt to harmonize (but not replace) the work of existing national medicine regulatory bodies
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Advantages for sponsors

The hope is that this plan will not only reduce

the $350 million annual cost drug companies incur by having to win separate approvals from each member state but also that it will eliminate the protectionist tendencies of states unwilling to approve new drugs that might compete with those already produced by domestic drug companies
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Introduction
The Agency is responsible for the scientific

evaluation of applications for European marketing authorisations for both human and veterinary medicines (centralised procedure). Under the centralised procedure, companies submit a single marketing-authorisation application to the Agency. Once granted by the European Commission, a centralised (or Community) marketing authorisation is valid in all European Union (EU) and EEA-EFTA states (Iceland, Liechtenstein and Norway).
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Which medicines central procedure mandatory ?

All medicines for human and animal use derived from biotechnology and other high-tech

processes must be approved via the centralised procedure The same applies to all advanced-therapy medicines and human medicines intended for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases, as well as to all designated orphan medicines intended for the treatment of rare diseases.
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 The Agency constantly monitors the safety of medicines

through a pharmacovigilance network, and takes appropriate actions if adverse drug reaction reports suggest that the benefit-risk balance of a medicine has changed since it was authorised. Applications through the centralised procedure are submitted directly to the Agency. Evaluation by the Agency's relevant scientific committee takes up to 210 days, at the end of which the committee adopts an opinion on whether the medicine should be marketed or not. This opinion is then transmitted to the European Commission, which has the ultimate authority for granting marketing authorisations in the EU.
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 Decentralised procedure Using the decentralised procedure,

companies may apply for simultaneous authorisation in more than one EU country of medicines that have not yet been authorised in any EU country and that do not fall within the mandatory scope of the centralised procedure.

Committees within E M E A
Committee for Medicinal Products for Human

Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Committee for Orphan Medicinal Products (COMP) Committee on Herbal Medicinal Products (HMPC) Paediatric Committee (PDCO) Committee for Advanced Therapies (CAT)made india

What are the criteria for orphan designation?

The medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition a ffecting no more than five in 10,000 persons in the European Union at the time of submission of the designation application (prevalence criterion),
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Benefits for company

Protocol assistance (scientific advice for

orphan medicines during the productdevelopment phase); Direct access to centralised marketing authorisation and 10-year marketing exclusivity; Financial incentives (fee reductions or exemptions); National incentives detailed in an inventory made available by the European Commission.
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 Since 1 February 2009, orphan medicinal

products are eligible for the following level of fee reductions: Full (100%) reduction for protocol assistance and follow-up; Full (100%) reduction for pre-authorisation inspections 50% reduction for new applications for marketing authorisation to applicants other than small and mediumsized enterprises;
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 Full (100%) reduction for new applications for

marketing authorisation only to small and medium-sized enterprises; Full (100%) reduction for post authorisation activities including annual fees only to small and medium sized enterprises in the first year after granting a marketing authorisation.

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What is a referral?
A referral is a procedure used to resolve disagreements and address concerns.

In a referral, the European Medicines Agency is requested to conduct, on behalf of the European Community, a scientific assessment of a particular medicine or class of medicines.
The medicine, or the class or medicines, is referred to the CHMP, so that the Committee

can make a recommendation for a harmonised position across the European Union.
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Why referral may be sought?

ranging from concerns over the safety of a

class of medicine to disagreements among Member States on the use of the medicine Referrals can be started by the European Commission, any Member State or by the company who makes the medicine.

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 At the end of the referral, the Committee

makes a recommendation, and the European Commission issues a decision to all Member States reflecting the measures to take to implement the CHMP recommendation.

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pharmacovigilance
The pharmacovigilance system in the European Union (EU) operates with the management and

involvement of national competent authorities, the European Commission as the competent authority for medicinal products authorised centrally for the whole EU and the European Medicines Agency. In some Member States, regional centres are in place under the co-ordination of the national competent authority.

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 Within this system, it is the role of the Agency

to co-ordinate the EU pharmacovigilance system and to ensure the provision of advice for the safe and effective use of medicines.

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EudraVigilance
EudraVigilance is a data processing network

and management system for reporting and evaluating suspected adverse reactions during the development and following the marketing authorisation of medicinal products in the European Economic Area (EEA).

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Purpose of eudravigilance
Electronic exchange of suspected adverse reaction reports (referred to as Individual Case

Safety Reports) between the European Medicines Agency (EMEA), national Competent Authorities, marketing authorisation holders, and sponsors of clinical trials in the EEA; Early detection of possible safety signals associated with medicinal products for Human Use
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 Continuous monitoring and evaluation of

potential safety issues in relation to reported adverse reactions; Decision making process, based on a broader knowledge of the adverse reaction profile of medicinal products especially in the frame of Risk Management.

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Two modules for submission

The EudraVigilance Clinical Trial Module

(EVCTM) to facilitate the electronic reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) The EudraVigilance Post-Authorisation Module (EVPM) designed for postauthorisation ICSRs

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 Volume 9A Guidelines on compassionate use

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Compassionate use
All medicinal products must be authorised

before they can be marketed in the European Union. However, a treatment option for patients in the European Union suffering from a disease for which no satisfactory authorised alternative therapy exists or who cannot enter a clinical trial, may be the use of an unauthorised medicinal product in a compassionate use programme
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 Compassionate use programmes are

intended to facilitate the availability to patients of new treatment options under development. National compassionate use programmes, making medicinal products available either on a named patient basis or to cohorts of patients, are governed by individual Member States legislation.
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 Thank you !!

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