On 18 February 2021, Thai FDA announced that any GMP clearance approval letter which was approved before the date of this announcement will have their validity extended to April 2022 automatically.
The renewal for the GMP clearance approval of the site needs to be performed 6 months before the expiry date.
Thai FDA shall conduct on-site inspection in the following cases:
– supporting documents submitted does not meet, or cannot be assessed to meet the standard required for drug manufacturing as required by Ministry of Public Health’s regulations
– any other cases as determined by Thai FDA
The Appendix of this announcement contains the list of documents required for the initial application and renewal application for GMP clearance approval according to different certification available for the site:
- Certification issued by ASEAN Listed Inspection Service
- Certificationissued by PIC/S Member
- Certification by the WHO Prequalification Team
- Certification bynon–PIC/S member
- Certification by WHO––Listed Authority
The Appendix also contains the list of documents required for on-site inspection.
More details in ประกาศสำนักงานคณะกรรมการอาหารและยา เรื่อง หลักเกณฑ์ วิธีการ และเงื่อนไขในการขอ การออก และการต่ออายุหนังสือรับรองมาตรฐานการผลิตยาแผนปัจจุบันของสถานที่ผลิตยาในต่างประเทศ Announcement of the Thai Food and Drug Administration on Criteria, Methods and Conditions to Apply for, the Issuance and Renewal of Modern Drug Manufacturing Standards Certificate of Overseas Pharmaceutical Manufacturers 18 Feb 2021
https://www.fda.moph.go.th/sites/drug/Shared%20Documents/Law04-Notification-ThFDA/FDA-20210218.PDF/