RegNexia monitors health authorities across 6 regions — from the FDA and EMA to emerging markets — so your team never has a blind spot.
3 authorities monitored
FDA
United States
Food and Drug Administration
Drugs, biologics, devices, food, cosmetics
Health Canada
Canada
Health Products and Food Branch
Pharmaceuticals, biologics, medical devices
COFEPRIS
Mexico
Federal Commission for Protection against Sanitary Risks
Drugs, medical devices, health products
10 authorities monitored
EMA
European Union
European Medicines Agency
Centralised procedure, CHMP, PRAC, CAT opinions
MHRA
United Kingdom
Medicines & Healthcare products Regulatory Agency
UK licensing, pharmacovigilance, devices
Swissmedic
Switzerland
Swiss Agency for Therapeutic Products
Human and veterinary medicines, medical devices
BfArM
Germany
Federal Institute for Drugs and Medical Devices
National procedure, narcotics, medical devices
ANSM
France
Agence Nationale de Sécurité du Médicament
National licensing, pharmacovigilance, clinical trials
CBG-MEB
Netherlands
Medicines Evaluation Board
National and mutual recognition procedures
AIFA
Italy
Italian Medicines Agency
National licensing, reimbursement, pharmacovigilance
AEMPS
Spain
Spanish Agency for Medicines and Medical Devices
National licensing, biologics, pharmacovigilance
MPA
Sweden
Medical Products Agency
National licensing, clinical trials oversight
URPL
Poland
Office for Registration of Medicinal Products
National and MRP procedures
8 authorities monitored
PMDA
Japan
Pharmaceuticals and Medical Devices Agency
Drug approval, pharmacovigilance, GCP inspection
NMPA
China
National Medical Products Administration
Drug registration, clinical trial oversight, devices
CDSCO
India
Central Drugs Standard Control Organization
Drug approval, clinical trials, medical devices
TGA
Australia
Therapeutic Goods Administration
ARTG registration, biologics, pharmacovigilance
MFDS
South Korea
Ministry of Food and Drug Safety
Drug approval, safety surveillance, clinical trials
HSA
Singapore
Health Sciences Authority
Product licensing, pharmacovigilance, devices
TFDA
Taiwan
Taiwan Food and Drug Administration
Drug licensing, clinical trial oversight
Medsafe
New Zealand
New Zealand Medicines and Medical Devices Safety Authority
Medicines approval, pharmacovigilance
4 authorities monitored
ANVISA
Brazil
National Health Surveillance Agency
Drug registration, clinical trials, pharmacovigilance
COFEPRIS
Mexico
Federal Commission for Protection against Sanitary Risks
Drug licensing, devices, health products
ANMAT
Argentina
National Administration of Drugs, Food and Medical Devices
Drug registration, clinical trials
INVIMA
Colombia
National Institute for Food and Drug Surveillance
Drug registration, sanitary surveillance
4 authorities monitored
SFDA
Saudi Arabia
Saudi Food and Drug Authority
Drug registration, clinical trial oversight, devices
MOHAP
UAE
Ministry of Health and Prevention
Drug licensing, clinical trial approval
SAHPRA
South Africa
South African Health Products Regulatory Authority
Drug registration, clinical trials
EDRA
Egypt
Egyptian Drug Authority
Drug registration, pharmacovigilance
3 authorities monitored
ICH
Global
International Council for Harmonisation
Technical guidelines for pharma development globally
WHO
Global
World Health Organization
Global health standards, prequalification, safety signals
PIC/S
Global
Pharmaceutical Inspection Co-operation Scheme
GMP standards and harmonisation