Drug Registration

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Drug Registration

Pharmacovigilance

Chemical Manufacturing Control

Registration of Medical Devices

Pharmaceutical Affairs

International Relationship

Regulations (Drug Registration)

2009/09/30： Notes of the Assessment of the API DMF & Checklist for Technical Document for the API DMF

2009/09/03：Amendment to Article 38-1 of the Guideline on Drug Review and Approval

2009/02/13：Amendment to Article 22-1 of the Guideline on Drug Review and Approval

2008/11/21： Guideline on the Examination and Registration of Drugs -- Guideline on Biosimilar products

2006/09/01：Regulations on “Fee Schedule for the Application of Examination and Registration of Pharmaceuticals and Medical Equipment/Apparatus”

2006/02/27：The Regulations on Disclosing Drug Data

2005/01/07： Drug Review and Registration Guideline

2001/12/05：Guidelines on Drug Review and Registration – for Biological In Vitro Diagnostic Reagents

2001/06/28： 628 announcement