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).
