Members

Argentina

National Institute of Drugs
Instituto Nacional de Medicamentos (INAME)

Inspection Department
Avda. Caseros 2161 – 1er Piso
AR - C1264AAB Buenos Aires

Australia
 

Therapeutic Goods Administration (TGA)

Departement of Health

Manufacturing Quality Branch
PO Box 100
AU - Woden Act 2606

Austria
 

Federal Office for Safety in Health Care 

Bundesamt für Sicherheit im Gesundheitswesen (BASG)

Traisengasse 5,
AT - 1200 Vienna

Belgium

Federal Agency for Medicines and Health Products

Agence Fédérale des Médicaments et des Produits de Santé (AFMPS)
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)

Avenue Galilée 5/03
BE - 1210 Bruxelles

Brazil

National Health Surveillance Agency (ANVISA)
Agência Nacional de Vigilância Sanitária (ANVISA)

SIA, Trecho 5, Área Especial 57
BR - 71205-050 Brasília - Distrito Federal

*  The competence for GMP/GDP inspections in Brazil is shared between the central authority, National Health Surveillance Agency (ANVISA), and the Brazilian regional authorities, which count as one PIC/S Participating Authority. The Brazilian Local Health Surveillance considered as PIC/S Participating Authorities and represented in PIC/S by ANVISA are: Superintendência de Vigilância em Saúde – SUVISA/GO (State of Goiás); Diretoria de Vigilância em Medicamentos e Congêneres – DVMC (State of Minas Gerais); Secretaria de Estado da Saúde – SESA (State of Paraná); Superintendência de Vigilância Sanitária – SUVISA (State of Rio de Janeiro); Centro Estadual de Vigilância em Saúde – CEVS/ Divisão de Vigilância Sanitária – DVS (State of Rio Grande do Sul); Diretoria de Vigilância Sanitária – DIVS (State fo Santa Catarina) e; SIVISA Sistema de Informação em Vigilância Sanitária (State of São Paulo). 

Bulgaria

Bulgarian Drug Agency (BDA)

8, Damyan Gruev Str.
BG - 1303 Sofia

Accession to PIC Scheme July 2023

Canada

Health Canada / Santé Canada

Regulatory Operations and Enforcement Branch (ROEB)
Direction générale des opérations réglementaires et de l'application de la loi (DGORAL)

13th floor, Jeanne Mance Building
200 Eglantine Drive
CA - Ottawa, Ontario, K1Y 1G9

Accession to PIC Scheme January 1999

Chinese Taipei

Taiwan Food and Drug Administration (TFDA)

Ministry of Health and Welfare
No.109, Ln. 130
Sec. 1, Academia Rd.
Nangang District
TW (R.O.C.) - Taipei City 115

Accession to PIC Scheme January 2013

Croatia

Agency for Medicinal Products and Medical Devices of Croatia
Agencija za lijekove i medicinske proizvode (HALMED)

Ksaverska cesta 4
HR - 10 000 Zagreb

Accession to PIC Scheme January 2016

Cyprus

Pharmaceutical Services (CyPHS)

Ministry of Health
1475 Lefkosia (Nicosia)

Czech Republic

State Institute for Drug Control
Státní Ústav pro Kontrolu Léčiv (SÚKL)

Srobárova 48
CZ - 100 41 Prague 10

Czech Republic

Institute for State Control of Veterinary Biologicals
and Medicines (ISCVBM)

Hudcova 56A
CZ - 621 00  Brno

Denmark

Danish Medicines Agency (DKMA)

1 Axel Heides Gade
DK - 2300 Copenhagen S

Estonia

State Agency of Medicines (SAM)

1 Nooruse Str.
EE - 50411 Tartu

Finland

Finnish Medicines Agency (FIMEA)

Mannerheimintie 103b
P.O. Box 55
FI - 00034 FIMEA Helsinki

France

French National Agency for Medicines and Health Products Safety
Agence nationale de sécurité du médicament et des produits de santé (ANSM)

143/147 Boulevard Anatole France
FR - 93285 Saint Denis

France

Agency for Food, Environmental & Occupational Health Safety
Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES)

14 rue Claude Bourgelat
PA de la Grande Marche - Javené - CS 70611
FR - 35306 FOUGERES Cedex

Germany

Federal Ministry of Health *
Bundesministerium für Gesundheit (BMG)

Rochusstr. 1
DE - 53123 Bonn
Germany

Greece

Greek National Organisation for Medicines
Εθνικός Οργανισμός Φαρμάκων (EOF)

Messoghion Ave 284
GR - Holargos 155 62 (ELLAS)

Hong Kong SAR, China

Pharmacy and Poisons Board of Hong Kong (PPBHK)

1/F, Shun Feng International Centre
182 Queen's Road East
Wainchai
HK - Hong Kong 

Hungary

National Center for Public Health and Pharmacy (NCPHP)

2-6 Albert Florian ut (PO. box 777, 1437 Budapest)
HU - 1097 Budapest

Iceland

Icelandic Medicines Agency (IMA)

Vínlandsleið 14
IS - 113 Reykjavik

Indonesia

Indonesian Food and Drug Authority (Badan POM)
(Badan Pengawas Obat dan Makanan Republik Indonesia)

Jl. Percetakan Negara No.23
ID - Jakarta 10560

Iran

Iran Food and Drug Administration (IFDA)

No. 30, Fakhr Razi St, Enghelab St,
IR - Tehran 1314715311

Ireland

Health Products Regulatory Authority (HPRA)

Kevin O'Mally House
Earlsfort Centre
Earlsfort Terrace
IE - Dublin 2

Israel

Institute for Standardization and Control
of Pharmaceuticals (ISCP)

Eliav St. 9,
P.O. Box 34410
IL - Jerusalem 91342

Italy

Italian Medicines Agency 
Agenzia Italiana del Farmaco (AIFA)

Via del Tritone, 181
IT - 00187 Rome

Italy (Veterinary Agency)

Directorate General for Animal Health and Veterinary Medicinal Products
Direzione generale della sanità animale e dei farmaci veterinari (DGSAF)
Ministry of Health

Viale Giorgio Ribotta 5
IT - 00144 ROMA

Japan

Ministry of Health, Labour and Welfare (MHLW) *

1-2-2 Kasumigaseki Chiyoda-ku
JP - 100-8916 Tokyo

Korea (Republic of)

Ministry of Food and Drug Safety (MFDS)

Osong Health Technology Administration Complex
187, Osongsaengmyeong2-ro
Osong-eup, Heungdeok-gu
Cheongju-si, Chungcheongbuk-do
KR - 28159

Latvia

State Agency of Medicines
Zāļu valsts aģentūra (ZVA)

15, Jersikas St.
LV - 1003 Riga

Liechtenstein

Office of Healthcare
Amt für Gesundheit (AG)

Äulestrasse 51
Postfach 684
FL - 9490 Vaduz

Lithuania

State Medicines Control Agency (SMCA)

45A Studentų Str.
LT - 08107 Vilnius

Malaysia

National Pharmaceutical Regulatory Agency (NPRA)

Ministry of Health Malaysia
Lot 36, Jalan Prof. Diraja Ungku Aziz
46200 Petaling Jaya
MY - SELANGOR

Malta

Malta Medicines Authority (MMA)

Level 3, Sir Temi Żammit Building
Malta Life Sciences Park
MT - SAN GWANN SĠN 3000

Mexico

Federal Commission for the Protection Against Sanitary Risks (COFEPRIS)
Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)

Av. Marina Nacional No. 60, 4th floor
Tacuba, Miguel Hidalgo
MX - Ciudad de México 11410

Netherlands

Health and Youth Care Inspectorate*  
Inspectie Gezondheidszorg en Jeugd  (IGJ)

P.O. Box 2518
NL - 6401 DA Heerlen
Netherlands

* The competence for GMP/GDP inspections in the Netherlands is allocated to the central authority, Dutch Health and Youth Care Inspectorate (IGJ). IGJ is the PIC/S Participating Authority representing GMP/GDP for human as well as veterinary medicinal products. IGJ performs national and international GMP/GDP inspections representing the Health and Youth Care Inspectorate - Pharmaceutical Affairs as well as the Medicines Evaluation Board - Veterinary Medicinal Products Unit, which is mandated to issue GMP certificates on behalf of the Ministry of Economic Affairs.

New Zealand

Medicines and Medical Devices Safety Authority (Medsafe)
P.O. Box 5013
NZ - 6011 Wellington

Norway

Norwegian Medical Products Agency (NOMA)

Postboks 240, Skøyen
NO - 0213 Oslo

Poland

Chief Pharmaceutical Inspectorate (CPI)

12 Senatorska Street
PL - 00-082 Warsaw

Portugal

National Authority of Medicines and Health Products, IP
Autoridade Nacional do Medicamento e Produtos de Saúde IP (INFARMED IP )

Avenida do Brasil, no 53
Pavilhão 21-A
PT - 1700 Lisbon

Romania

National Agency for Medicines and Medical Devices of Romania

(NAMMDR)

Strada Maior Aviator Sanatescu 48
Sectorul I
RO - 011478 Bucharest

Saudi Arabia

Saudi Food and Drug Authority (SFDA)
3292 Northern ring Rd. Alnafal District
SA - 13312-6288 Riyadh

Accession to PIC Scheme July 2023

Singapore

Health Sciences Authority (HSA)

11 Biopolis Way
#11-01 Helios
SG - 138667

Slovak Republic

State Institute for Drug Control (SIDC)

Kvetná 11
SK - 825 08 Bratislava 26
Slovak Republic

Slovenia

Agency for Medicinal Products and Medical Devices
Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)

Slovenčeva ulica 22
SI - 1000 Ljubljana

South Africa

South African Health Products 
Regulatory Authority (SAHPRA)

Private Bag X 828
ZA - 0001 Pretoria

Spain

Spanish Agency of Medicines and Medical Devices*
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)

Departamento de Inspección y Control de Medicamentos
C/ Campezo, 1
ES - 28022 Madrid

*  The competence for GMP/GDP inspections in Spain is shared between the central authority, Spanish Agency for Medicines and Medical Devices (AEMPS), and the Spanish regional authorities, which count as one PIC/S Participating Authority. All Spanish Medicinal Authorities, which are listed on the AEMPS web site, are considered as PIC/S Participating Authorities and are represented in PIC/S by the AEMPS.

Sweden

Swedish Medical Products Agency (MPA)

Box 26
SE - 751 03 Uppsala
Sweden

Switzerland

Swiss Agency for Therapeutic Products (Swissmedic)

Hallerstrasse 7
CH - 3012 Bern

Thailand

Food and Drug Administration (Thai FDA)

Ministry of Public Health
88/24 Tiwanon Road
Nonthaburi 11000
Thailand

Accession to PIC Scheme August 2016

Türkiye

Turkish Medicines and Medical Devices Agency (TMMDA)

Inspectorate
Söğütözü Mahallesi 2176 Sokak No 5
TR - 06520 Çankaya - Ankara

Ukraine

State Service of Ukraine on Medicines and Drugs Control (SMDC)

120 A, Beresteiska av.

UA - 03115 Kyiv

Ukraine

United Kingdom

Medicines & Healthcare Products Regulatory Agency (MHRA)

10 South Colonnade
Canary Wharf
GB - London E14 4PU

United Kingdom

Veterinary Medicines Directorate (VMD)

Woodham Lane, New Haw
Addlestone
GB - Surrey KT15 3LS

U.S.A

U.S. Food and Drug Administration (US FDA)

10903 New Hampshire Avenue
Building 31, Room 3502
Silver Spring, Maryland  20993