DANH SCH CC NC THAM GIA EMA, ICH HOC PIC/s

STT

Tn nc

T chc tham gia

EMA

PIC/s

1
2

Argentina
Australia

Austria

Belgium

Bulgaria

Canada

Cyprus

Czech Republic

X
X

X
X

Tn c quan qun l dc tham gia

ICH

Denmark

10

Estonia

11

Filand

PIC/s
PIC/s
PIC/s
EMA
PIC/s
EMA
EMA

Argentinian National Institute of Drugs (INAME)

Australian Therapeutic Goods Administration (TGA)
Austrian Medicines and Medical Devices Agency (AGES)
Austrian Agency for Health and Food Safety

PIC/s

Canadian Health Products and Food Branch Inspectorate (HPFB

PIC/s
EMA

Cypriot Pharmaceutical Services (CyPHS)

PIC/s

1. Czech State Institute for Drug Control (SKL)

2. Czech Institute for State Control of Veterinary Biological
(ISCVBM)

EMA
PIC/s
EMA
PIC/s
EMA
PIC/s

Belgian Federal Agency for Medicines and Health Products (AF

Bulgarian Drug Agency

Czech State Institute for Drug Control (SKL)

Danish Health and Medicines Authority (DHMA)
Estonian State Agency of Medicines (SAM)
Finnish Medicines Agency (FIMEA)

11

12

13

Filand

France

Germany

PIC/s

EMA

French National Drug and Health Products Safety Agency (ANS

PIC/s

1. German Central Authority of the Laender for Health Prot

Medicinal Products and Medical Devices (ZLG)
2. German Federal Ministry of Health (BMG)

EMA

1. Federal Institute for Drugs and Medical Devices

2. Paul Ehrlich Institute

Greece

15

Hungary

16

Iceland

17

Indonesia

18

Ireland

19

Israel

Finnish Medicines Agency (FIMEA)

1. French National Drug and Health Products Safety Agency (A

2. French Agency for Food, Environmental & Occupationa
(ANSES)

14

EMA

PIC/s
EMA
PIC/s

Greek National Organisation for Medicines (EOF)

EMA

Hungarian National Institute for Quality- and Organizational

Healthcare and Medicines National Institute of Pharmacy (NIP)

PIC/s

Icelandic Medicines Agency (IMA)

PIC/s

Indonesian National Agency for Drug and Food Control (NADF

PIC/s
EMA

Irish Medicines Board (IMB)

PIC/s

Israeli Institute for Standardization and Control of Pharmaceutic

X
X

20

Italy

21

Latvia

22

Liechtenstein

23

Lithuania

24

Luxembourg

25

Malaysia

26

Malta

27

Netherlands

28

Norway

X
X

Italian Medicines Agency (AIFA)

Latvian State Agency of Medicine (ZVA)

PIC/s

Liechtenstein's Office of Healthcare (AG)

PIC/s
EMA

Lithuanian State Medicines Control Agency (SMCA)

EMA

Ministry of Health

PIC/s

Malaysian National Pharmaceutical Control Bureau (NPCB)

PIC/s
EMA

Maltese Medicines Authority (MAM)

PIC/s

Netherlands' Inspectorate of Health Care (IGZ)

EMA

1. Medicines Evaluation Board

2. Healthcare Inspectorate

PIC/s

Norwegian Medicines Agency (NOMA)

PIC/s

Polish Main Pharmaceutical Inspectorate (MPI)

EMA

1. Office for Registration of Medicinal Products, Medical Devi

Products
2. Main Pharmaceutical Inspectorate

PIC/s
EMA
PIC/s
EMA

Portuguese National Authority of Medicines and Healt

(INFARMED)
Romanian National Agency for Medicines and Medical Devices
National Medicines Agency

X
X

PIC/s
EMA
PIC/s
EMA

29

Poland

30

Portugal

31

Romania

32

Singapore

33

Slovakia

34

Slovenia

35

South Africa

36

Spain

37

Sweden

38
39

Switzerland
Ukraine

40

United Kingdom

41

USA

X
X
X

X
X

PIC/s
PIC/s
EMA
PIC/s
EMA
PIC/s
PIC/s
EMA
PIC/s
EMA
PIC/s
PIC/s
PIC/s
EMA
PIC/s

Singapore's Health Sciences Authority (HSA)

Slovak State Institute for Drug Control (SIDC)
Slovenian Agency for Medicinal Products and Medical Devices
South African Medicines Control Council (MCC)
Spanish Agency of Drugs and Health Products (AEMPS)
Swedish Medical Products Agency (MPA)

Swiss Agency for Therapeutic Products (Swissmedic)

Ukrainian State Administration on Medicinal Products (SAUMP
United Kingdom's Medicines and Healthcare Products Re
(MHRA)
U.S. Food and Drug Administration (US FDA)

Ghi ch: Ngoi ra cc t chc tham gia ICH cn c cc t chc di y:

EFPIA

USA

1. Austria
Fachverband der Chemischen Industrie sterreichs (FCIO)
2. Belgium
Association Gnrale de lIndustrie du Mdicament (AGIM-pharma.be)
3. Denmark
The Danish Association of the Pharmaceutical Industry (LIF)
4. Finland
Pharma Industry Finland (PIF)
5. France
Les Entreprises du Mdicament (LEEM)
6. Germany
Verband Forschender Arzneimittelhersteller (VFA)
7. Greece
Hellenic Association of Pharmaceutical Companies (SfEE)
8. Ireland
Irish Pharmaceutical Healthcare Association (IPHA)
9. Italy
Associazione delle imprese del farmaco (Farmindustria)
10. Netherlands
Vereniging Innovatieve Geneesmiddelen Nederland (Nefarma)
11. Norway
Legemiddelindustriforeningen Norwegian Association of Pharmaceutical Manufacturers
(LMI)
12. Poland
Employers Union of Innovative Pharmaceutical Companies (Infarma)
13. Portugal
Associao Portuguesa da Indstria Farmacutica (Apifarma)
14. Spain
Asociacin Nacional Empresarial de la Industria Farmacutica (Farmaindustria)
15. Sweden

1. Food and Drug

Administration (FDA)
2. Pharmaceutical Research
and Manufacturers of
America (PhRMA)

(LMI)
12. Poland
Employers Union of Innovative Pharmaceutical Companies (Infarma)
13. Portugal
Associao Portuguesa da Indstria Farmacutica (Apifarma)
14. Spain
Asociacin Nacional Empresarial de la Industria Farmacutica (Farmaindustria)
15. Sweden
Lkemedelsindustrifreningen The Swedish Association of the Pharmaceutical Industry
(LIF)
16. Switzerland
scienceindustries
17. Turkey
Arastirmaci Ilac Firmalari Dernegi (AIFD)
18. United Kingdom
The Association of the British Pharmaceutical Industry (ABPI)

/s

dc tham gia

gs (INAME)
nistration (TGA)
vices Agency (AGES)
d Safety

es and Health Products (AFMPS)

Branch Inspectorate (HPFBI)

PHS)

trol (SKL)
l of Veterinary Biologicals and Medicines

ol (SKL)

ity (DHMA)

(SAM)

Products Safety Agency (ANSM)

ronmental & Occupational Health Safety

oducts Safety Agency (ANSM)

e Laender for Health Protection regarding

ices (ZLG)
h (BMG)

dical Devices

dicines (EOF)

uality- and Organizational Development in

nstitute of Pharmacy (NIP)

g and Food Control (NADFC)

nd Control of Pharmaceuticals (ISCP)

VA)

(AG)

Agency (SMCA)

Control Bureau (NPCB)

Care (IGZ)

MA)

rate (MPI)

nal Products, Medical Devices and Biocidal

f Medicines and Health Products, IP

cines and Medical Devices (NAMMD)

y (HSA)

ol (SIDC)

ducts and Medical Devices (JAZMP)

uncil (MCC)
Products (AEMPS)

MPA)

cts (Swissmedic)
edicinal Products (SAUMP)
Healthcare Products Regulatory Agency

US FDA)

d and Drug
istration (FDA)
rmaceutical Research
anufacturers of
ca (PhRMA)

JAPAN
1. Ministry of
Health, Labour and
Welfare (MHLW)
2. Japan
Pharmaceutical
Manufacturers
Association
(JPMA).