CONSULTATION ON TRANSITION PERIOD FOR INDUSTRY TO PROVIDE GMP EVIDENCE FOR DRUG SUBSTANCE MANUFACTURERS
Dear Industry Stakeholders,
The Health Sciences Authority (HSA) is seeking industry stakeholders’ feedback on the transition period that may be required for industry to fully comply with the submission requirement for Evidence of Good Manufacturing Practice (GMP) Compliance of chemical drug substance (DS) manufacturers. The full implementation will apply prospectively to New or Generic Drug Applications (NDA/GDA) and Minor Variation Applications (MIV-1) for addition of a new DS manufacturer.
This will align the GMP requirement for chemical DS manufacturers with that currently applied to biologic DS and enable companies to better assure the quality of therapeutic products that they supply in Singapore for use in our patients.
The acceptable GMP Compliance Evidence is as follows:
1. A valid GMP certificate issued by any PIC/S* authority; or GMP inspection report from PIC/S authority which do not issue GMP certificates together with the close-out letter.
The DS of interest has to be stated on the GMP certificate. Where the DS of interest is not specified on the DS GMP certificate, a Written Confirmation** for the DS of interest from the PIC/S authority which issued the GMP certificate should also be submitted.
Alternatively, the following GMP evidence may also be used as supporting documents for Chemical DS manufacturers:
2. A valid Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) issued by EDQM.
3. Active Pharmaceutical Ingredient (API) Registration Certificate listed on EUDRAGMP.
*Pharmaceutical Inspection Co-operation Scheme (PIC/S)
** Written Confirmation using the European Union (EU) template is acceptable
Companies are highly encouraged to submit the required evidence if it is currently available to support their regulatory applications. For companies which are not currently supporting their regulatory applications with the above GMP evidence, HSA will provide a transition period to facilitate a smooth implementation.
[Updated 16 Aug 2023]: Companies were invited to participate in an online consultation which was conducted between 14 July – 14 August 2023 to provide feedback on the lead time that may be required before the full implementation. The online consultation is now closed. We thank all industry stakeholders for their participation. We are analysing the responses received. More updates and frequently asked questions (FAQs) will be published in September 2023.