Singapore: New Drug GMP Requirements for Drug Substance Makers

Beginning on October 1, 2024, drug companies submitting NDAs, GDAs, and minor variation applications in Singapore must also incorporate GMP Compliance Evidence for their drug substances. There is a grace period until September 30, 2024, but Singapore’s HSA recommends that drug substance manufacturers submit GMP compliance evidence as soon as possible.

GMP compliance evidence can include one of three things – First, a GMP certificate, a GMP inspection report, or a written statement from the PIC/S authority that issued the GMP certificate for the related drug substance. Alternatively, second, a registrant certificate of the valid API for the drug substance recorded on the EVDRAGMP. Or, in situations where one of the two conditions above cannot be met, a third option is to provide the monograph of the European Pharmacopeia (CEP) issued by the EDQM for a valid Certificate of Suitability for the drug substance. Please note drug applications that do not have one of the required drug substance GMP evidences, will be rejected by Singapore’s HSA starting from the fall of next year.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

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