MAIN REGULATORY BODIES AROUND THE WORLD FOR PHARMACEUTICAL PRODUCTS

MAIN REGULATORY BODIES AROUND THE WORLD FOR PHARMACEUTICAL PRODUCTS

Medicines are chemical or natural products used for healing, diagnosing, treating and improving health. These medicines contain API and Excipient. API is the main active drug which provide therapeutic effect and biologically active.  Excipient is non-active ingredient added in formulation along with API in medicine formulation.

Drugs or Medicines are very high importance as these are life saving, health improving, biologically active, provide therapeutic effect.   Drugs or Medicines provide adverse effect or lead to death if they are not manufactured with care and not manufactured in GMP (Good Manufacturing Practices) environment. Due to high risk, every country has its own regulatory body or regulatory authority. These regulatory bodies or regulatory authorities make and enforce rules and regulations and also prepare and issue guidelines for drugs or medicines manufacturing, licensing, registration, marketing, labeling and packaging of pharmaceutical products like tablets, injections, syrups, eye drops, ointment cream, spray, inhalers, liquid and OSD  (oral solid dosage) etc.

List of Main Regulatory Authority around the World

Country	Name of  Regulatory Authority (Full and Short Form of Name)
USA	USFDA – Unites States Food and Drug Administration
UK	MHRA - Medicines and Healthcare Products Regulatory Agency
Australia	TGA - Therapeutic Goods Administration (TGA)
India	CDSCO - Central Drug Standard Control Organization (CDSCO)
Canada	TPD – Therapeutic Product Directorate
	HPFBI – Health Product & Food Branches Inspectorate
Europe	EMA - European Medicines Agency
New Zealand	Medsafe - Medicines and Medical Devices Safety Authority
	ANZTPA – New Zealand Therapeutic Product Authority
China	CFDA - China Food and Drug Administration
South Africa	MCC - Medicines Control Council
Sri Lanka	SPC – State Pharmaceutical Corporation, Ministry of Health
Brazil	ANVISA - Agencia Nacional de Vigiloncia Sanitaria
Vietnam	MOH - Ministry of Health
Malaysia	DCA – Drug Control Authority

Along with these Regulatory Bodies there are some international organizations also to control these pharmaceutical products like WHO (World Health Organization) and ICH (International Conference on Harmonization).