The Asian Harmonization Working Party met in Bangkok in November. It was a busy meeting with publication of a range of final guidance documents ranging from standard submission dossiers, software regulation, adverse event reporting and more, as well as range of updates from member economies.
Combination Products White paper
The long awaited white paper on Combination Products was endorsed at the Bangkok meeting. The white paper provides a comprehensive overview of current global practices in regulation of combination products. It paves the way for work to start on a new guidance document expected next year.
New Dossier Templates
The Bangkok meeting endorsed the final Common Submission Dossier Template, expected to become the standard formats across much of the AHWP membership.
The Clinical Working Group has been particularly busy with finalization of several new guidances Clinical Evaluation of devices and specific guidance on IVD validations.
Good Distribution Practice (GDP) audit
With high levels of import of medical technology, adequate control of distribution practices has become an increasing emphasis in some emerging markets, with Good Distribution Practices (GDP) being adopted widely among AHWP membership. The Bangkok meeting endorsed new guidance on GDP audit practice as well as guidances on audit and reporting more generally.
The full list of documents endorsed was:
- CSDT Guidance
- Regulation of Combination Products – a Review of International Practice
- MD IVD definition
- Guidance document on Medical Device Software
- Adverse Event Reporting
- Clinical Evaluation
- Clinical Evidence for Medical Devices– Key Definitions and Concepts
- Clinical Evidence for IVD medical devices – Key Definitions and Concepts
- Clinical Evidence for IVD medical devices – Scientific Validity Determination
- Auditing Checklist
- Guidance on Regulatory Auditing of QMS of MD Distributors – Auditing Strategy
- Regulatory Audit Report Guidance Document
- Guidance for Medical Device Naming Rule