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Implementation of Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) manufacturers

Dear Industry Stakeholders,

Background

1. As part of continual regulatory enhancement to assure the quality standard of therapeutic products supplied in Singapore, the Health Sciences Authority (HSA) will roll out a transition plan for companies to fully comply with the requirement for Evidence of Good Manufacturing Practice (GMP) Compliance of Chemical Drug Substance (DS) manufacturers. This will align the GMP requirements for both chemical and biologic DS manufacturers. The full implementation of the GMP requirements for all DS manufacturers will enable companies to better assure the quality of therapeutic products supplied in Singapore for use in our patients.

2. Following HSA’s initial communication with industry stakeholders on 14 July 2023 and the industry consultation conducted from 14 July to 14 August 2023, HSA is pleased to share the detailed plan. We would like to thank industry stakeholders for their feedback and support for the initiative. Taking into consideration the responses received during the consultation, HSA will provide a 1-year transition period for companies to fully comply with the requirement. We have also enhanced the clarity of the types of evidence that companies can submit as proof of GMP compliance.

Details of Implementation

3. The 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.

4. The types of GMP Compliance Evidence are as follows. Companies may submit either (a), (b) or (c) to support the applications:

a) A valid GMP certificate issued by any PIC/S* authority. For PIC/S authorities which do not issue GMP certificates, either the GMP inspection report together with the close-out letter where applicable, or other evidence from the authority such as the manufacturing licence to demonstrate that the site complies with PIC/S GMP requirements can be submitted.

The GMP evidence must cover the DS of interest. Examples of such evidence include:

  • A GMP certificate with the DS of interest stated; or
  • A GMP inspection report or manufacturing licence with the DS of interest included in the scope; or
  • A Written Confirmation** for the DS of interest from the PIC/S authority which issued the GMP certificate

b)  A valid Active Pharmaceutical Ingredient (API) Registration Certificate covering the DS of interest listed on EUDRAGMP.

c) A valid Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) for the DS of interest issued by EDQM.

*Pharmaceutical Inspection Co-operation Scheme (PIC/S)
** Written Confirmation using the European Union (EU) template or any other official document from the PIC/S authority is acceptable 

Date of Implementation

5. Effective 1 October 2024, NDAs, GDAs, and MIV-1 applications (Addition of new DS manufacturer) are to be supported by the required GMP Compliance Evidence for DS manufacturers. Applications submitted on or after 1 October 2024 without the required GMP evidence will not be accepted.

6. From now until 30 September 2024, companies are strongly encouraged to provide the GMP Compliance Evidence if it is available. This will help to ensure a smooth transition when the requirement takes effect.

7. Information on the implementation, including a list of frequently asked questions (FAQs) can be found here.

8. The following sections of the Guidance on Therapeutic Product Registration in Singapore have been updated:

  • Chapter C (section 15.1)
  • Appendix 2A
  • Appendix 3A
  • Appendix 13A
  • Appendix 14A

 

Industry member, Therapeutic Products
Published:

Regulatory Updates