Asian Harmonization Working Party Updates

The Asian Harmonization Working Party (AHWP) had its last meeting on October 26 and 27 in Chengdu, China, where it discussed schedules and plans for the Common Submission Dossier Template (CSDT), Post-market Alert Systems (PMAS) and other tasks. For CSDT and PMAS, the AHWP is considering following GHTF documents such as STED and NCAR (National Competent Authority Report). AHWP hopes to implement the CSDT and PMAS starting in 2008. For more information on CSDT and PMAS, please refer to Vol. 6 Issue 9 and Vol. 7 Issue 4 of the Asia Medical eNewsletter here.

In addition to CSDT and PMAS, the AHWP also plans to establish working groups on harmonizing Quality Management Systems, Quality System Audits, Clinical Evidence Requirements, and Capacity Building/Regulatory Training. The chairs for these workings groups (except for Capacity Building) have not yet been determined.

During the meeting, Malaysia presented a comparative study on medical device regulations in Asian economies along with its findings and recommendations. One recommendation was to adopt GHTF definition and risk-based classification of medical devices. Of the 14 countries studied (including China, Hong Kong, Malaysia, Singapore, and others), 8 had adopted the GHTF definition of medical devices, but only 4 had adopted GHTF risk-based classifications. Another recommendation was for AHWP to consider region-wide nomenclature for medical devices.

Other recommendations included building a common reporting format for adverse events and recalls as well as a comprehensive database to monitor and analyze these events. The ASEAN PMAS currently in discussion would play a key role in the creation of such a database. Malaysia also presented recommendations for capacity-building to ensure that member economies have the resources to properly implement these international standards.

Many of the AWHP’s working groups and initiatives are currently in review stage only. Their actual implementation is expected to start in 2008-2009.