Regulatory Authorities role in Pharmacovigilance, Drug Safety and Clinical Trials

The aim of regulatory authorities is to protect the safety and rights of the subjects participating in a trial, and to safeguard that trials are adequately designed to meet scientifically sound objectives.

The regulatory authorities ensure compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to impose the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing and labeling of medicinal products.

Please see below list of regulatory authorities and organizations recognized in particular countries. Click on the links to know more details about the specific regulatory authority.

List of Regulatory Authorities:

EMEA (European Union)

European medicines agency

http://www.ema.europa.eu/ema/

USFDA (USA)

US Food and Drug administration

http://www.fda.gov/

CDSCO (India)

Central Drugs Standard Control Organization (CDSCO)

http://www.cdsco.nic.in/forms/Default.aspx

MHRA(UK)

Medicines and Healthcare products Regulatory Agency

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

TGA(Australia)

Therapeutic Goods Administration

https://www.tga.gov.au/tga-basics

HEALTH CANADA (Canada)

http://www.hc-sc.gc.ca/index-eng.php

MCC (South Africa)

Medicines Control Council

http://www.mccza.com/

ANVISA (Brazil)

Agência Nacional de Vigilância Sanitária or National Health Surveillance Agency of Brazil

http://www.emergogroup.com/resources/brazil/anvisa

SFDA (China)            

State Food and Drug Administration

http://www.sfda.com/

NAFDAC (Nigeria)

National Agency for Food and Drug Administration and Control

http://www.nafdac.gov.ng/

MEDSAFE (Newzeland)

Medicines and Medical Devices Safety Authority

http://www.medsafe.govt.nz/

MHLW (Japan)

Ministry of Health, Labour and Welfare

http://www.mhlw.go.jp/english/

MCAZ (Zimbabwe)

Medicines Control Authority of Zimbabwe

http://www.mcaz.co.zw/

PMDA (Japan)

Pharmaceuticals and Medical Devices Agency

https://www.pmda.go.jp/english/

SWISSMEDIC (Switzerland)

Swiss Agency for Therapeutic Products

https://www.swissmedic.ch/?lang=en

KFDA(Korea)

Korea Food and Drug Administration

http://eng.kfda.go.kr/nitr/message.php

MoH (Sri Lanka)

Ministry of Health & Indigenous medicine

http://www.health.gov.lk/en/