Go To Content
:::
Home
Sitemap
Contact us
Bilingual Glossary
中文版
Go
Your browser does not support JavaScript.
If the webpage function does not work properly, please open the browser JavaScript status.
Hot:
food additives,
Nutrition label,
Medicinal Products
Food
Drugs
Controlled Drugs
Medical Devices
Cosmetics
About Taiwan FDA
:::
GMP/GDP for Medicinal Products
Medicines manufacturers
2015 International Conference on Medical Device Regulations in the Asia-Pacific Region
Activities
News
Safety information
:::
you are in:
Home
GMP/GDP for Medicinal Products
Routine Assessment
Medicines manufacturers
Routine Assessment
Routine Assessment
【Update Date:
2015-10-06
】
unit:品質監督管理組
I:Administration of Overseas Plants
Based on the consistent regulations of domestic and overseas pharmaceutical manufacturers, Ministry of Health and Welfare promotes the ongoing managements of overseas pharmaceutical manufacturers in order to ensure the quality of input medicines. According to Regulations of Medicament Manufacturer Inspection, t
he follow-up inspections of foreign pharmaceutical manufacturers of imported drugs shall be conducted every two years and may extend one to two years depending on the management system and standards for pharmaceutical manufacturing in country of origin which is according to Regulations of Medicament Manufacturer Inspection.
II:
Legal
Basis
1.
Pharmaceutical Affairs Law (PAL), Article 57.
2.
Pharmaceutical Manufacturer Inspection Measures,
Article 9.
III:
Dual
Tracks
In order to bolster the legal basis for plant inspections overseas, December 2004 revisions to the “Regulations of Pharmaceutical Manufacturer Inspection” specified that, for all plant approval applications involving overseas pharmaceutical manufacturers, local agents or subsidiaries of the manufacturer needed to fill out relevant application forms, pay relevant fees, prepare relevant PMF information on overseas plants and submit completed applications to the TFDA.
1.
Dossier Review
2.
On-Site Inspection