各國藥品許可證管理制度之介紹 - cde.org.tw

1 RegMed 2014 Vol. 41 7 / 1 (1) (2) 1. (European Medicines Agency, EMA) 1234/2008/EC 5 9 EMA EMA (1) 5 5 (2) 5 5 EMA (conditional approved) EMA (1) type IA minor variations IA IAIN (a) IA 12 EMA (annual reporting system) (b) IAIN (2)

2 Type IB minor variations 30 (3) type II major variations 1 RegMed 2014 Vol. 41 8 2. ( Food and Drug Administration, USFDA) section 506A of the Federal Food, Drug, and Cosmetic Act (the Act) 21 CFR 314 FDA 60 FDA (Form 2252) $ 98,380 USD ( 2013 300 ) FDA FDA FDA 30 FDA 3.

3 (Swissmedic, Decentralized ) Art. 9, para. 2, VAM 5 6 $ 500 CHF( 16,000 ) Swissmedic Art. 10 & 11, VAM 46 4. (BfArM, Decentralized ) Article 24 of Directive 2001/83/EC MA (marketing authorisation) 5 $ 13,600 EURO ( 40 ) Article 23 of Directive 2001/83/EC MAH(marketing authorization holder) BfArM ($300 EURO ~ $2,000 EURO) RegMed 2014 Vol. 41 9 5. (Health Canada) (Health Canada) Therapeutic Products Directorate (TPD) FDR section 10 DIN (Drug Identification Number) DIN Health Canada FDR section (a) DIN ANDF(Annual Drug Notification Form) 30 30 ANDF (Schedule D, Biologics and Genetic Therapies) YBPR (Yearly Biologic Product Reports) Guidance for Sponsors Lot Release Program for Schedule D (biologic)

4 Drugs 2011 $ 69,400 CDN Guidance Document - Fees for the Right to Sell Drugs Health Canada NOC (Notice of Compliance) FDR section NOC (1) SNDS (Supplement New Drug Submission) (2) 30 (No Objection Letter) NC(Notification Changes) (3) FDR Annual Notification (4) ANDF(Annual Drug Notification Form) 6. (Health Singapore Agency, HSA) HSA Renew@PRISM RegMed 2014 Vol.

5 41 10 ( ) $ 300 SGD( 7,000 ) PRISM HSA CPP (Certificate of a Pharmaceutical Product) 7. (Australian Register of Therapeutic Goods, ARTG) (1) ( ) (2) ( ) (3) ARTG TGA Section 28 of the Therapeutic Goods Act 1989 (Effective 1 July 1995) TGA 1. European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: 2. 3. 4. 5. CMDh Best Practice Guide on the processing of renewals in the MRP/DCP (April 2013): 6.

6 Swissmedic: 7. 8. RegMed 2014 Vol. 41 11 9. 10. +on+licensing%2 Fcertification+inspections&collection=ag encies&profile=tga 11.