Background
The full implementation of the requirement for GMP compliance evidence for chemical DS manufacturers aims to align the GMP requirements for both chemical and biological DS manufacturers.
By requiring all DS manufacturers to comply with the GMP requirements, companies can better assure customers of the quality of therapeutic products supplied in Singapore.
The requirement for Evidence of GMP Compliance for all DS manufacturers will apply prospectively to New or Generic Drug Applications (NDA or GDA) and Minor Variation Applications (MIV-1) for the addition of a new DS manufacturer.
Dates of Implementation
From 1 October 2024 onwards, NDAs, GDAs and MIV-1 applications must be supported by the required GMP compliance evidence for DS manufacturers. Applications submitted on or after 1 October 2024 without the required GMP compliance evidence will not be accepted.
From now until 30 September 2024, the HSA strongly encourages companies to provide Evidence of GMP Compliance where available, to ensure a smooth transition when the requirement is fully implemented.
Types of GMP compliance evidence
Companies may submit any of the following GMP compliance evidence to support the NDA, GDA and/or MIV-1 applications:
- A valid GMP certificate issued by any Pharmaceutical Inspection Co-operation Scheme (PIC/S) authority.
For PIC/S authorities that do not issue GMP certificates, either the GMP inspection report together with the close-out letter, where applicable, or other evidence from the authority to demonstrate that the site complies with PIC/S GMP requirements can be submitted. Such other GMP evidence must cover the DS of interest and may include a GMP certificate with the DS of interest stated, a GMP inspection report or manufacturing license with the DS of interest included in the scope, or a written confirmation (using the European Union template or any other official document from the PIC/S authority) for the DS of interest from the PIC/S authority that issued the GMP certificate;
- A valid Active Pharmaceutical Ingredient (API) Registration Certificate covering the DS of interest listed on EUDRAGMP; or
- A valid Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) for the DS of interest issued by EUDRAGMP.
Further information on the implementation and a list of frequently asked questions (FAQs) can be found here.
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For further information and to discuss what this development might mean for you, please get in touch with your usual Baker McKenzie contact.
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