Industry Links

Regulatory Authorities & Agencies

• FDA (U.S. Food and Drug Administration)fda.gov
• EMA (European Medicines Agency)ema.europa.eu
• MHRA (UK Medicines and Healthcare products Regulatory Agency)gov.uk/mhra
• Health Canadacanada.ca/en/health-canada
• TGA (Australia Therapeutic Goods Administration)tga.gov.au

Harmonisation & International Guidelines

• ICH (International Council for Harmonisation)ich.org
• WHO (World Health Organization - Medicines & Health Products)who.int/teams/health-product-and-policy-standards

Middle East (GCC & Levant)

1. Saudi Arabia — SFDA (Saudi Food and Drug Authority)sfda.gov.sa
2. United Arab Emirates — EDE (Emirates Drug Establishment)Federal standalone regulator for pharmaceuticals and medical devicesede.gov.ae
3. United Arab Emirates — MOHAP (Ministry of Health and Prevention)mohap.gov.ae
4. Kuwait — KFDA / DFC (Drug & Food Control Administration)moh.gov.kw
5. Qatar — MOPH (Ministry of Public Health - Pharmacy & Drug Control)moph.gov.qa
6. Oman — DGPADC (Directorate General of Pharmaceutical Affairs & Drug Control)moh.gov.om
7. Bahrain — NHRA (National Health Regulatory Authority)nhra.bh
8. Jordan — JFDA (Jordan Food and Drug Administration)jfda.jo
9. Lebanon — MOPH (Ministry of Public Health)moph.gov.lb

North Africa

1. Egypt — EDA (Egyptian Drug Authority)edaegypt.gov.eg
2. Morocco — DMP (Direction du Médicament et de la Pharmacie / Ministry of Health)sante.gov.ma
3. Algeria — ANPP (Agence Nationale des Produits Pharmaceutiques)anpp.dz
4. Tunisia — DPM (Direction de la Pharmacie et du Médicament)dpm.tn

Sub-Saharan Africa

1. South Africa — SAHPRA (South African Health Products Regulatory Authority)sahpra.org.za
2. Nigeria — NAFDAC (National Agency for Food and Drug Administration and Control)nafdac.gov.ng
3. Kenya — PPB (Pharmacy and Poisons Board)pharmacyboardkenya.org
4. Ghana — FDA Ghana (Food and Drugs Authority)fdaghana.gov.gh
5. Tanzania — TMDA (Tanzania Medicines and Medical Devices Authority)

East Asia

1. Japan — PMDA (Pharmaceuticals and Medical Devices Agency)pmda.go.jp
2. China — NMPA (National Medical Products Administration)nmpa.gov.cn
3. South Korea — MFDS (Ministry of Food and Drug Safety)mfds.go.kr
4. Taiwan — TFDA (Taiwan Food and Drug Administration)fda.gov.tw

South Asia

1. India — CDSCO (Central Drugs Standard Control Organization)cdsco.gov.in
2. Pakistan — DRAP (Drug Regulatory Authority of Pakistan)dra.gov.pk
3. Sri Lanka — NMRA (National Medicines Regulatory Authority)nmra.gov.lk

Southeast Asia (ASEAN)

1. Singapore — HSA (Health Sciences Authority)hsa.gov.sg
2. Malaysia — NPRA (National Pharmaceutical Regulatory Agency)Drug regulator under MOHnpra.gov.my
3. Thailand — Thai FDA (Food and Drug Administration Thailand)fda.moph.go.th
4. Indonesia — BPOM (Badan Pengawas Obat dan Makanan / National Agency of Drug and Food Control)pom.go.id
5. Philippines — FDA Philippines (Food and Drug Administration Philippines)fda.gov.ph

Western & Central Europe

1. Germany — BfArM (Federal Institute for Drugs and Medical Devices)bfarm.de
2. France — ANSM (National Agency for the Safety of Medicines and Health Products)ansm.sante.fr
3. Italy — AIFA (Italian Medicines Agency)aifa.gov.it
4. Spain — AEMPS (Spanish Agency of Medicines and Medical Devices)aemps.gob.es
5. Netherlands — CBG-MEB (Medicines Evaluation Board)cbg-meb.nl
6. Belgium — FAMHP (Federal Agency for Medicines and Health Products)famhp.be
7. Austria — BASG (Federal Office for Safety in Health Care)basg.gv.at
8. Poland — URPL (Office for Registration of Medicinal Products, Medical Devices and Biocidal Products)urpl.gov.pl

Nordics & Northern Europe

1. Sweden — MPA / Läkemedelsverket (Medical Products Agency)lakemedelsverket.se
2. Denmark — DKMA (Danish Medicines Agency / Lægemiddelstyrelsen)laegemiddelstyrelsen.dk
3. Norway — NOMA (Norwegian Medical Products Agency / Direktoratet for medisinske produkter)noma.no
4. Finland — Fimea (Finnish Medicines Agency)fimea.fi
5. Ireland — HPRA (Health Products Regulatory Authority)hpra.ie

Eastern & Southern Europe

1. Czech Republic — SÚKL (State Institute for Drug Control)sukl.eu
2. Hungary — OGYÉI / NNGYK (National Center for Public Health and Pharmacy)ogyei.gov.hu
3. Portugal — INFARMED (National Authority of Medicines and Health Products)infarmed.pt
4. Greece — EOF (National Organization for Medicines)eof.gr
5. Romania — ANMDMR (National Agency for Medicines and Medical Devices)anm.ro
6. Turkey — TİTCK (Turkish Medicines and Medical Devices Agency)titck.gov.tr
7. Switzerland — Swissmedic (Swiss Agency for Therapeutic Products)swissmedic.ch

Latin American Economies (PAHO Level 4 Authorities)

1. Brazil — ANVISA (Agência Nacional de Vigilância Sanitária)gov.br/anvisa
2. Mexico — COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)gob.mx/cofepris
3. Argentina — ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica)argentina.gob.ar/anmat

Medical Devices & MedTech Regulators

1. United States — FDA CDRH (Center for Devices and Radiological Health)fda.gov/medical-devices
2. United Kingdom — MHRA (Regulating Medical Devices in the UK)gov.uk
3. European Union — European Commission Medical Devices Sector (MDR / IVDR)health.ec.europa.eu
4. Canada — Health Canada Medical Devices (MDL / MDEL)canada.ca
5. Australia — TGA Medical Devices (ARTG)tga.gov.au/products/medical-devices
6. Japan — PMDA Medical Device Review Reportspmda.go.jp
7. South Korea — MFDS Medical Devices Approval Processmfds.go.kr
8. Singapore — HSA Medical Deviceshsa.gov.sg/medical-devices
9. Malaysia — MDA (Medical Device Authority)portal.mda.gov.my
10. Saudi Arabia — SFDA Medical Devices Marketing Authorisation (MDMA)mdma.sfda.gov.sa
11. Switzerland — Swissmedic Medical Devicesswissmedic.ch
12. Brazil — ANVISA Medical Devices (Produtos para Saúde) Product Lookupgov.br/anvisa