Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) published an updated regulatory guidance on the conduct of bioequivalence (BE) studies called the "Malaysian Guideline for Bioequivalence Inspection". This guideline offers an overview of the scope of bioequivalence inspections aimed at ensuring the integrity and quality of BE studies, which are crucial for establishing the interchangeability of generic medicines with innovator products.
The main objectives of the BE inspection are:
To verify the integrity of data and reports submitted for product registration.
To ensure compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) during the conduct of BE studies.
To ensure that BE studies are conducted ethically and scientifically sound.
This guideline applies to all BE studies conducted in Malaysia for the registration of generic drugs. It also covers foreign studies that are submitted for registration purposes in Malaysia, ensuring that these studies meet NPRA's standards.
Application Procedures:
Local BE Centre Requirements: Provides requirements and procedural steps for BE centers in Malaysia.
Foreign BE Centre Requirements: Outlines the expectations and procedural framework for BE centers outside Malaysia.
Categories of BE Inspection:
NPRA BE Centre Compliance Programme Inspection: Regular inspections to ensure ongoing compliance.
Study-Specific Inspection: Focuses on particular studies to verify adherence to protocol.
Extraordinary Inspection: Conducted in response to specific issues or concerns raised during previous inspections.
Conduct of BE Inspection
Announcement of the Inspection: Details the procedures for informing centers about upcoming inspections.
Opening and Closing Meetings: Describes the format and content of meetings that mark the start and end of inspections.
Conduct of Inspection: Highlights how the inspection will be performed, focusing on documentation, practices, and compliance.
Reporting After Inspection: Describes the process for reporting findings, both non-compliance and compliance-related, post-inspection.
Final Decision on BE Inspection: Explains how the final decision on inspection outcomes will be communicated to the inspected centers.
The inspection process includes:
Pre-Inspection: Review of the BE study protocol and prior audit reports.
On-Site Inspection: NPRA inspectors visit the study site to review facilities, processes, and documentation.
Post-Inspection: A final report is generated, and any non-compliance issues must be addressed by the sponsor or CRO.
The guideline includes appendices that provide additional details on technical requirements, reporting templates, and examples of acceptable practices in BE studies.
This guideline provides a comprehensive framework to safeguard the quality and safety of generic drugs approved in Malaysia and for more details, refer to the full guideline here.
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