The Regulatory Working Group (RWG) aims to provide independent scientific opinions and recommendations relating to the Critical Quality Attributes (CQAs) of Microneedle Array Patches (MAPs) and how they can be demonstrated through appropriate standardized tests.
PATH has formed a Center of Excellence for MAP technology. This is a 4 year initiative to accelerate the development of MAPs as a technology platform for high-priority needs (vaccines and essential medicines) in low- and middle-income countries. As part of this Center of Excellence, PATH has partnered with Cardiff University to Chair a group that aims to help define the regulatory pathway for MAPs in order to expedite clinical translation of the technology. The group includes representatives with MAP expertise in both the commercial and academic sectors, vaccine development experts and representatives from national regulatory authorities, international pharmacopoeia and the WHO pre-qualification of medicines programme.
The RWG’s activities include: (1) defining the delivery system; (2) identifying critical quality attributes; (3) developing test methods for MAPs; and (4) evaluating the sterility requirements for MAP products.
This is a collaborative endeavour project and so we are keen to garner the views of all interested parties. If you want to contribute to the work then please register your interest, collaborate and/or talk to us at dissemination events.
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RWG co-chairs, attending members and observers during a face-to-face meeting in July 2019 (PATH, Seattle, USA)
