P328: Stakeholder Perspectives on Malaysia’s New Regulation: Transitioning from Guidelines to Clinical Trial Legislation
Poster Presenter
Khim Boon Tee
Senior Principal Assistant Director
National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia Malaysia
Objectives
To evaluate stakeholder acceptance and identify regulatory concerns regarding Malaysia’s proposed clinical trial regulations framework.
Method
A descriptive cross-sectional study using a two-stage hybrid method: five engagement sessions with 168 stakeholders (sponsors, ethics committees, investigators) and a Unified Public Consultation (UPC) yielding 116 qualitative comments.
Results
Analysis revealed high engagement from investigators (n=76) and sponsors (n=29). Quantitative data showed strong support for Clinical Trial Authorisation (CTA) requirements, product labeling standards, and reliance on reference authorities. Qualitatively, while the shift to a legal framework was supported, primary concerns centered on "approval timelines" and "increased regulatory burden." Notably, investigators highlighted the potential financial impact of new fees on Investigator-Initiated Trials (IITs). Over 80% of participants advocated for a centralized regulatory database to enable real-time safety and approval tracking. Overall, stakeholders view the regulation as a necessary step for international competitiveness but remain wary of administrative friction.
Conclusion
The study confirms broad stakeholder support for the Sale of Drugs (Medicinal Products for Clinical Trials) (SODIP) regulations to align Malaysia with international Good Clinical Practice (GCP) standards and World Health Organization (WHO) recommendations. However, for Malaysia to remain a competitive global hub for clinical research, the implementation must proactively address identified concerns. Key recommendations include streamlining administrative processes to prevent delays and reviewing fee structures for IITs. Successfully balancing rigorous legal oversight with operational efficiency will ensure the new framework strengthens participant safety and data integrity without compromising the speed of clinical development in the region.
