;   Medical Translation Insight: Pharma regulations in Asia - ForeignExchange Translations

Pharma regulations in Asia

Regulatory requirements governing pharmaceuticals vary widely across AsiaThe current issue of Regulatory Focus (login required) has an interesting article called "Regulatory Aspects of Pharma Business in Asia".

The article examines the format of regulatory submissions, language requirements, and requirements for site inspections and local trials across ten countries. Countries across Asia require basically the same information in their regulatory submissions but require it to be presented in a country-specific format. Asia provides tremendous opportunities for pharmaceutical companies but, as the article points out, navigating the requirements and avoiding the pitfalls can be difficult for small and mid-size companies.

Here are a couple of highlights:

Country
China
Format of MAA Dossier
Non-CTD format
Translations required?
Yes
URL for more info
eng.sfda.gov.cn/eng/

Country
Hong Kong
Format of MAA Dossier
Non-CTD
Translations required?
No
URL for more info
www.psdh.gov.hk/eps/webpage.jsp

Country
Japan
Format of MAA Dossier
CTD (with unique M1.2)
Translations required?
M1 and M2 only
URL for more info
www.nihs.go.jp/english/usefulinfo/drugs.html

Country
Korea
Format of MAA Dossier
Non-CTD
Translations required?
Yes
URL for more info
www.kfda.go.kr/open_content/english/index.html

Country
Taiwan
Format of MAA Dossier
Non-CTD
Translations required?
No
URL for more info
www.cde.org.tw/eng/prospects/future.html

Country
India
Format of MAA Dossier
Non-CTD
Translations required?
No
URL for more info
cdsco.nic.in

Country
Malaysia
Format of MAA Dossier
Non-CTD
Translations required?
Yes, for some documents
URL for more info
www.bpfk.gov.my

Country
Philippines
Format of MAA Dossier
Non-CTD
Translations required?
No
URL for more info
www.bfad.gov.ph

Country
Singapore
Format of MAA Dossier
ASEAN format
Translations required?
No
URL for more info
www.hsa.gov.sg/publish/hsaportal/en/home.html

Country
Thailand
Format of MAA Dossier
Non-CTD
Translations required?
Yes, for certain portions
URL for more info
www.fda.moph.go.th/eng/index.stm


ForeignExchange Translations provides specialized Korean, Thai, Chinese, and Japanese translation services to pharmaceutical and medical device companies. Contact us to learn more.

0 Comments:

Post a Comment





 

Services | Resources | Company | Contact Us | Blog | Home

(c) Copyright 2010, ForeignExchange Translations, Inc.