GOVENMENT
MOHW/TFDA/others
MOHW
TFDA
others
CDE
Medical Regulation/others
Medical Regulation
others
HOSPITAL
IRB/Hospital Announcement
IRB
Hospital Announcement
MOHW
[Announcements] Revise Guidance for Pediatric Pharmacolinetic Studies
01
25 Mar 2021
[Announcements] To commence a period of public comments for drafting "Fee-charging Standards of Review for the Registration of Orphan Drugs"
02
23 Mar 2021
[Announcements] Revise the relevant certification documents for the simplified process of applying for the review of clinical trials of new drugs
03
20 Oct 2020
[Announcements] Adverse Drug Reaction Report Forms and Completion Guidelines
04
04 Sep 2020
[Announcements] Amendment on partial articles of "Regulations for Good Clinical Practice"
05
28 Aug 2020
[Announcements] Charge Standards of Review Fees for the Registration of Western Medicines
06
21 Jul 2020
[Announcements] Amendment on Article 21 of "Regulations of Bioavailability and Bioequivalence Studies"
07
12 Jun 2020
[Announcements] Revised the application and review criteria for clinical trials of human cell therapeutics
08
04 May 2020
[Announcements] Recommendations and principles for the implementation of drug clinical trials during the prevention of severe and special infectious pneumonia
09
10 Apr 2020
[Announcements] Amendment on Article 21 of "Regulations of Bioavailability and Bioequivalence Studies"
10
02 Mar 2020