New Members – New Guidance – Expanded Training Program
The Asian Harmonisation Working Party held its 20th annual meeting in Cebu, Philippines this week. The Technical committee adopted a range of new guidances and AHWP continued to extend membership and promote training and capacity building activities.
AHWP annual meetings are a compilation of Technical Committee gatherings, training days and the formal AHWP annual meeting for acceptance of new members and endorsement of this years’s crop of guidance documents.
Submission Dossiers – not quite harmonised yet
This year’s training days focused especially on two aspects – submission dossiers and postmarket reporting.
As more AHWP members develop updated regulatory requirements, the format of submission dossiers continues to be a challenge. The AHWP CSDT format has been available for some time for medical devices – and is based on the European STED. However IMDRF developments of the new IMDRF Table of Contents with a completely different format to STED, and the tendency for each jurisdiction to add local supplementary requirements means that manufacturers still need to be prepared to adjust dossiers for each separate market. The changes in Europe are being watched with keen interest, Many AHWP jurisdictions rely on CE certificate in order to be able to abridge local regulatory reviews.
On the postmarket side, collection and exchange of information between agencies continues to develop and a number of AHWP members now have online adverse event reporting systems.
The Technical Committee has been hard at work over the past year resulting in endorsement of a slew of new guidances at the Cebu meeting.
Following on the publication of a white paper on Combination products last year, AHWP formalised a detailed guidance on Regulatory Practices for Combination products which ranges across GMP, clinical trials, and review practices. Also on the review front, AHWP published a guidance on Minor Change Reporting
The IVD working group has been particularly busy – with the keenly anticipated guidance on Principles of Conformity Assessment for IVDs and the Submission Dossier for IVDs both published this year.
Following the established practices in IMDRF, AHWP adopted a guidance on Risk Categorisation of Software.
Look out for publication of these new guidances on the AHWP website in the coming weeks.
AHWP continues to expand membership – with UAE, Oman, Bahrain and Zimbabwe entering the fold this year. Industry Association APACMed also joined as an associate organisation.
20 years on
AHWP celebrated its 20th birthday in Cebu. The Philippine FDA hosted a smoothly run meeting with their customary warmth and hospitality.
AHWP has certainly grown. From an original base principally directed to training and capacity building for merging economies, AHWP now stands as a well established harmonisation body, with a growing body of its own technical guidance and track record of fostering regional cooperation and harmonisation.
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