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Pharmaceutical Regulatory Agencies and Organizations around the World: Scope and Challenges in Drug Development

As the pharmaceutical industries throughout the world are moving ahead towards becoming more and more competitive, regulatory agencies are being established in various countries across the globe. Regulatory agencies and organizations play a vital role to meet the requirements of legal procedures related to drug development process in a country. In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, USFDA(USA), marketing MHRA(UK), and labeling of pharmaceutical CDSCO(India), products. HEALTH

TGA(Australia),

CANADA(CANADA), MCC(South Africa),ANVISA (Brazil) , EMEA (European Union), SFDA (China),NAFDAC(Nigeria), MEDSAFE(Newzeland),

MHLW(Japan), MCAZ(Zimbabwe), SWISSMEDIC(Switzerland), KFDA(Korea), MoH (Sri Lanka) are the few regulatory agencies and organizations established in respective countries. World Health Organization (WHO), Pan American Health Organization (PAHO), World Trade Organization (WTO), International Conference on Harmonization (ICH), World Intellectual Property Organization (WIPO) are some of the international regulatory agencies and organizations which also play essential role inall aspects of pharmaceutical regulations related to drug product registration,

manufacturing, distribution, price control, marketing, research and development, and intellectual property protection. The major challenges of these regulatory agencies and organizations around the world is to ensure the safety, quality and efficacy of medicines and medical devices, harmonization of legal procedures related to drug development, monitoring and ensuring compliance with statutory obligations. They also play a vital role to ensure and increase regulatory implementation in non-regulated parts of the world for safety of people residing there. The present study describes a brief review of various regulatory bodies of major developed and developing countries and the scope and challenges of such regulatory organizations in drug development and delivery of safe and effective healthcare products to individuals around the world. Scenario in India with respect to the rules and regulations set by the regulatory bodies CDSCO (Central Drugs Standards Control Organization) under the governance of Indian Ministry of Health & Family Welfare controlling the Indian Pharmaceutical industry with drug approval, regulation and pharmacy licensing in India. New drug approvals for the Indian market, pharmaceutical surveillance for India, defining and implementing enforcement policies for Indian drug market across the globe are some of the features handled by CDSCO. Drug control administration division of CDSCO handles the complete pharmacies regulations through its acting body state drug control offices, also known as FDA offices (Food & Drug Administration Offices). FDA inspects and issues the licenses to pharmacies. FDA regulates the Pharmacy Act of 1940 to meet the enhanced safety measures and quality pharmaceutical production. The National Pharmaceutical Pricing Authority (NPPA), which was instituted in 1997 under the Department of Chemicals and Petrochemicals, which fixes or revises the prices of medicines, maintains data on production, exports and imports

and market share of pharmaceutical firms; and enforces and monitors the availability of medicines. WHO guidelines on medicines policy, intellectual property rights, financing & supply management, quality & safety, selection & rational use of medicines, technical co-operation and traditional medicines.

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