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GMP Autorities

GMP Autorities
국가/지역/기관 사이트명
Australia_TGA

Therapeutic Goods Administration

Canada

Health Canada

Canada

Health Canada/GMP

EU_ EDQM

European Directorate for the Quality of Medicines & HealthCare

EU_EMA

European Medicines Agency

EU_Eudratlex

EU Registration-Eudralex

EU_HMA

Heads of Medicines Agencies

Germany_BfArM

Federal Institute for Drugs and Medical Devices

Demark_DKMA

Danish Health and Medicines Authority

Finland_fimea

Finnish Medicines Agency

Iceland_IMA

Icelandic Medicines Agnecy

Norway_NMA

Norwegian Medicines Agency

Sweden_MPA

Medical Prodcuts Agency

Swissmedic

Swiss Agency for Therapeutic Products

UK MHRA

Medicines and Healthcare products Regulatory Agency

US GPO

US Government Printing Office_CFR Title 21

US NIH

National Institues of Health

US FDA

Food and Drug Administration

US FDA

Drug Applications and CGMP Regulations

US FDA

Federal Food, Drug, and Cosmetic Act

US FDA

Guidance, Compliance, & Regulatory Information

US FDA

Regulatory Information-Guidances (new 2015)

South Africa MCC

Medicines Control Council

WHO

WHO Technical Reports: Specifications for Pharmaceutical Preparations

대한민국 식품의약품안전처

Ministry of Food and Drug Safety

대한민국

국가법령센터(법제처)

일본 국립의약품식품위생연구소

National Institute fo Health Science

일본 의약품의료기구총합기구

pharmaceuticals and Medical Devices Agency

중국 국가식품약품감독관리국

State Food and Drug Administration (중국어)

중국 국가식품약품감독관리국(영어)

State Food and Drug Administration (영어)

product Animations

product Animations

ICH

ICH of Technical Requirements for Registration of Pharmaceuticals for human Use

GMP Search

GMP Search

PharmOut GMP Library

PharmOut GMP Library

askaboutvalidation

askaboutvalidation

Maas & Peither GMP News

Maas & Peither

eye on FDA

eye on FDA

ECA GMP News

ECA GMP

GMP Q&A

GMP Q&A
국가/지역/기관 사이트명
WHO

GMP Question and Answers

ICH

FAQs

Australia

Questions & answers on the code of good manufacturing practice

Canada

GMP Questions and Answers

EMA

Q&A GMP

UK MHRA

GMP FAQs

US FDA

Q&A on CGMP for Drugs

US FDA

Q&A on CGMP for Drugs

Pharmweb

Pharmweb

Training Site

Training Site
국가/지역/기관 사이트명
product Animations

product Animations

국제/국가별단체

국제/국가별단체
국가/지역/기관 사이트명
ICH

ICH Quality Guidelines

CGPA

Canadian Generic Pharmaceutical Association

ECA

GMP database

ECA

ECA GMP News

PICS

Pharmaceutical Inspection Co-operation Scheme

GMP Institues

ISPE GMP Institute

IFPMA

International Federation of Pharmaceutical Manufacturers & associations

IGPA

International Generic Pharmaceutical Alliance

Eucomed

European Medical Device Industry Group

IPEC

The International Pharmaceutical Excipients Council Europe

ISPE

International Society for Pharmaceutical Engineering

PDA

Parenteral Drug Association

APIC

Active Pharmaceutical Ingredients Committee

CEFIC

The European Chemical Industry Council

aaps

American Association of Pharmaceutical Scientists

APhA

American Pharmaceutical Association

DIA

Drug Information Association

IEST

Institute of Environmental Sciences and Technology

ICCCS

International Confederation of Contamination Control Societies

Search Site

Search Site
국가/지역/기관 사이트명
데이터가 없습니다.

GMP News Site

GMP News Site
국가/지역/기관 사이트명
데이터가 없습니다.

Glossary

Glossary
국가/지역/기관 사이트명
ISPE Glossary

ISPE Glossary

Maas & Peither

Maas & Peither