GLOSSARY - Regulatory Affairs Japan

Entries in the Glossary contain snapshot views of the key concepts and definitions of the regulated medicinal products in Japan.

Important dedication of the JAD Glossary is to collect, organize and provide understandable navigation between Japanese terms and often more than a single known/used translation in English, best exemplified in entries such as PAL or National Drug Tariff List .


Glossary of Terms and Definitions

 

Approval Review
Accredited Foreign Manufacturers (AFM)
Biological product
Blinded documents
Classes of drugs
Common Technical Document (CTD)
Cosmetics
Drugs
Elapsed Review Period
JSCC
European Drug Master File (EDMF)
Marketing Authorization Holder (MAH)
Master Files (Japan)
Materials originating from living organisms
Medical device
Medicinal product
Medicines agency
Mutual Recognition Agreement (MRA)
NHI Drug Tariff List
Orphan drug designation (ODD)
Package insert
PAFSC
Pharmacovigilance
Quasi-drugs
Radiopharmaceuticals
Recommendation
Retrievable documents
Shonin
Stages in Approval Process
Therapeutic categories

Updated on June 22, 2007 | Email inquiries | Orders