On 29 September 2023, the Health Science Authority (HSA) of Singapore published the decision from the initial communication with stakeholders on the GMP evidence requirement for chemical drug substance (DS) manufacturers.
In order to orient the GMP requirements for chemical and biologics DS manufacturers, starting from 1 October 2024, HSA will fully regulate the GMP evidence requirement for drug substance (DS) manufacturers. As for now, a 1-year transitional period is given for companies adapting to the requirement. The implementation is applied to New or Generic Drug Applications (NDA/GDA) and Minor Variation Applications (MIV-1) for the addition of a new DS manufacturer. Any applications submitted on or after 1 October 2024 not complying with the requirement will be rejected.
Listed below are types of GMP Compliance Evidence that can support the application submission:
Valid GMP certificate issued by PIC/S authority. Companies can attach the GMP inspection report together with the close-out letter, or, authority evidence such as manufacturing license that proves the site complies with PIC/S GMP requirements if the PIC/S authority does not issue GMP certificate.
Note that: GMP Evidence must cover the DS of interest
Valid Active Pharmaceutical Ingredient (API) Registration Certificate, that covers the DS of interest, listed in the EUDRAGMP
Valid Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) for the DS of interest issued by EDQM
Companies are suggested to start attaching the GMP evidence from now until 30 September 2024, for a smooth transition process and adapt to the actual enforcement. The implementation will ensure the quality of therapeutic products supplied in Singapore is in the finest condition.
Source: Health Science Authority (HSA)
Contact us at info@arqon.com for more information.
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