Registration of Medicinal Products

• No.

  Title

  Date

• 11

  [Generic Drug] ANDA Review process and timeline

  2019-02-14

• 12

  [New Drug] Performance of New Drug Approval in 2018

  2019-02-14

• 13

  [New Drug] Relaxation of CPP Requirements

  2019-02-14

• 14

  [New Drug] NDA Review Process and pathway

  2019-02-14

• 15

  [New Drug] Review Process and Timeline for NDAs/BLAs

  2019-02-14

• 16

  Application Form for Changes in Drug Registration

  2019-01-31

• 17

  Application form for drug review and registration

  2019-01-28

• 18

  [API] Technical Data Checklist for Examination and Registration Review of Active Pharmaceutical Ingredients

  2019-01-28

• 19

  Refuse to File Mechanism

  2018-10-19