Implementing Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) Manufacturers in Singapore

In its unwavering commitment to ensuring the highest standards of quality for therapeutic products available in Singapore, the Health Sciences Authority (HSA) is embarking on a significant regulatory enhancement journey. This initiative revolves around the implementation of a transition plan that mandates Evidence of Good Manufacturing Practice (GMP) Compliance for Chemical Drug Substance (DS) manufacturers.This strategic move seeks to align and standardize GMP requirements for both chemical and biological DS manufacturers, ultimately elevating the quality of therapeutic products accessible in Singapore, with a primary focus on patient well-being.

A Comprehensive Implementation Plan:

  1. Consultation and Stakeholder Engagement: The foundation of this implementation plan was laid after the HSA’s initial engagement with industry stakeholders on July 14, 2023. A dedicated consultation period followed, lasting from July 14 to August 14, 2023.
Implementing Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) Manufacturers in Singapore

This period of collaboration with industry stakeholders was instrumental in shaping the comprehensive plan. HSA acknowledges and appreciates the invaluable feedback and support received from industry partners.

  1. Extending the Transition Period: Responding to the valuable input received from industry stakeholders, HSA has made the decision to extend the transition period. Companies will now be provided with a 1-year window to fully align with the new requirement, demonstrating GMP Compliance Evidence. This extension aims to facilitate a smooth transition and ensure that all stakeholders can effectively adapt to the evolving regulatory landscape.
  2. Scope of Implementation: The implementation will have a prospective application, specifically targeting New or Generic Drug Applications (NDA/GDA) and Minor Variation Applications (MIV-1) that involve the addition of a new DS manufacturer.

Types of GMP Compliance Evidence:

Companies are afforded flexibility in providing evidence of GMP compliance, with three key options available:

  1. a) Valid GMP Certificate: Companies may opt to submit a valid GMP certificate issued by any Pharmaceutical Inspection Co-operation Scheme (PIC/S) authority. In instances where PIC/S authorities do not issue GMP certificates, companies have the option to submit the GMP inspection report, accompanied by the closure letter where applicable, or other evidence from the relevant authority. This alternate evidence should convincingly demonstrate compliance with PIC/S GMP requirements. Crucially, the GMP evidence must cover the specific DS of interest.
  2. b) Active Pharmaceutical Ingredient (API) Registration Certificate: An alternative avenue for compliance evidence is the submission of a valid API Registration Certificate, covering the DS of interest listed on EUDRAGMP.
  3. c) Certificate of Suitability (CEP): Companies can also provide a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) for the DS of interest. Such certificates are issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM).

The Implementation Date:

Commencing on October 1, 2024, all new drug applications (NDAs), generic drug applications (GDAs), and minor variation applications (MIV-1) involving the addition of new DS manufacturers must be accompanied by the requisite GMP Compliance Evidence for DS manufacturers. Applications submitted beyond this date, without the mandatory GMP evidence, will regrettably not be accepted.

Prior to this formal implementation date, extending until September 30, 2024, HSA strongly encourages companies to proactively provide GMP Compliance Evidence, should it be readily available. This collaborative approach will contribute significantly to a seamless and successful transition when the new requirement is formally implemented.

In Conclusion:

The introduction of GMP Compliance Evidence for DS manufacturers marks a pivotal milestone in Singapore’s commitment to maintaining and elevating the quality of therapeutic products. By harmonizing GMP requirements for both chemical and biological DS manufacturers, HSA is taking a substantial step towards ensuring the safety and efficacy of medical treatments offered to patients. Industry stakeholders are urged to embrace this transition, collaborate with HSA, and collectively work toward the shared objective of providing high-quality therapeutic products within Singapore’s healthcare ecosystem. To know more about the RABT Global GMP compliance expertise consult us .

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