Page 38 - 2017食品藥物管理署年報(英文版)

Outcomes
Medicinal Products 1.Accumulated DMF approvals are 3,038
2.A total of 245 items produced by 24 domestic API manufacturers
‧Strengthen import and self-use active have met GMP regulations for API; a total of 1,531 API import
pharmaceutical ingredient (API) manage- permits have met GMP regulations
ment – Establishing API Dug Master 3.A total of 127 domestic pharmaceutical manufacturers meet PIC/S
File (DMF) System GMP, a total of 268 international pharmaceutical manufacturers
‧Implement API registration that has met have passed on-site inspections
GMP 4.Accumulated registered controlled drug institutions and companies
‧Implement manufacturer meeting with are 15,413, accumulated professionals with controlled drug use
GMP standards certificates are 52,757 people
‧Implement controlled drug license system
Benefits

1.Control upstream API supply quality
2.All domestic pharmaceutical manufacturers have met PIC/S GMP
and align with international standards
Medical devices 3.Uphold controlled drug license management, prevent illegal use and
distribution of controlled drugs
4.Medical device manufacturers recognition and management,
‧Manufacturer registration & management optimize manufacturing quality and enhance the responsibilities of
‧Review expired GMP/QSD certificates businesses

Food

Outcomes Medical device manufacturers have met ‧Promote food businesses registration
national medical device GMP and imported
medical device QSD certifications, valid regis- system
tered licenses are 669 and 3,800, respectively ‧Strengthen boarder inspection of import
food
‧Reinforce overseas food factory inspec-
Benefits Optimize manufacturing quality and tion
enhance industries responsibilities,
ensure product quality
Outcomes 1.Over 420,000 food businesses have registered in
Food and Medicinal Businesses Registration Platform
2.A total of 676,570 lots of import food for custom
Cosmetics inspection, of which sampled 52,725 lots (account-
ed for 7.81%). The number of failure among
sampling lots accounted for 1.74%
‧Encourage cosmetics factories voluntarily to 3.Overseas factory inspection has covered 9 products
comply with cosmetics GMP across 7 countries
1.Control the distribution of food businesses
Benefits
2.Strengthen import food boarder inspection, prevent
products failed testing from import
Outcomes TFDA and IDB (MOEA) jointly 3.Reinforce overseas food factory inspection, effec-
promote cosmetic factories voluntarily tively supervise overseas food import
meeting with cosmetics GMP verifi-
cation system. A total of 23 factories
submitted applications in 2016 and
16 factories passed the inspection

Benefits Enhance product manufacturing
quality

Management of Source and Manufacturing