On October 7, 2024, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia announced the launch of a public consultation for the 2nd edition of the “Guidance Document and Guidelines for Registration of Cell and Gene Therapy Products (CGTPs) in Malaysia.” The consultation will run from October 7, 2024, to November 7, 2024, offering stakeholders a final chance to provide input before the guidelines are finalized. CGTPs, classified as biological products under Malaysia’s Sale of Drugs Act 1952 and Control of Drugs and Cosmetics Regulations 1984, play a critical role in medical advancements, requiring stringent oversight to ensure their safety, efficacy, and quality.
Key proposed amendments include:
- Refinement of Regulations: Adjustments for class I CGTPs, including updates to regulatory and safety frameworks.
- Revisions to GMP and GLP Requirements: Ensuring updated standards for Good Manufacturing Practice (GMP) and clarification of Good Laboratory Practice (GLP) requirements.
- Guideline Updates: Removal of outdated Guidelines for Good Tissue Practice (GTP).
The consultation involves a wide range of stakeholders, including CGTP manufacturers, pharmaceutical companies, associations, practitioners, researchers, and academicians. The document aligns with both national and international guidelines, such as those from the World Health Organization (WHO), International Conference on Harmonisation (ICH), U.S. FDA， 和 欧洲药品管理局（EMA）.
This update reflects Malaysia’s commitment to maintaining high standards in the evolving field of cell and gene therapy. For those involved, this consultation presents a vital opportunity to contribute to the future of CGTP regulation in the country.
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