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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 highlyregulated 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, marketing and labeling of pharmaceutical products.

USFDA(USA), MHRA(UK), TGA(Australia), CDSCO(India), HEALTH

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,

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manufacturing, distribution, price control, marketing, research and development,

and intellectual property protection.

The major challengesof 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 ofIndian Ministry of Health & Family Welfare controlling the Indian Pharmaceutical

industry with drug approval, regulation and pharmacy licensing in India. New drugapprovals for the Indian market, pharmaceutical surveillance for India, defining

and implementing enforcement policies for Indian drug market across the globe aresome 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 thelicenses to pharmacies. FDA regulates the Pharmacy Act of 1940 to meet theenhanced safety measures and quality pharmaceutical production.

The National Pharmaceutical Pricing Authority (NPPA), which was instituted in1997 under the Department of Chemicals and Petrochemicals, which fixes or

revises the prices of medicines, maintains data on production, exports and imports

http://nppaindia.nic.in/index1eng.htmlhttp://nppaindia.nic.in/index1eng.htmlhttp://nppaindia.nic.in/index1eng.htmlhttp://nppaindia.nic.in/index1eng.html

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and market share of pharmaceutical firms; and enforces and monitors theavailability 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.