Guidelines On The Reliance and Recognition of Good Manufacturing Practices (GMP) Decisions
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- Create Date October 9, 2026
- Last Updated October 9, 2026
Guidelines On The Reliance and Recognition of Good Manufacturing Practices (GMP) Decisions
The Pharmacy and Poisons Board (PPB) has issued this guideline to promote clarity, transparency and predictability in the recognition of Good Manufacturing Practice (GMP) decisions made by other regulatory authorities.
Guided by WHO Good Reliance Practices, the PPB adopts a risk-based approach to regulatory reliance, enabling the efficient use of regulatory resources while maintaining robust oversight of the quality, safety and efficacy of medical products. This approach supports regulatory convergence and facilitates timely patient access to quality-assured medical products.
The guideline outlines the criteria, procedures and regulatory pathways used by the PPB to assess foreign manufacturing sites, recognize foreign GMP decisions and determine the appropriate GMP inspection pathway. It is intended to help manufacturers and Marketing Authorization Holders (MAHs) understand the principles of regulatory reliance, applicable requirements and available assessment pathways.
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