Mission: The Microneedle Array Patch (MAP) Regulatory Working Group (RWG) aims to inform, guide and define the regulatory science of the MAP dosage form.
Scope of work: Our work focusses on the key contemporary CMC-related regulatory issues for MAPs, which are identified by consultation with key stakeholders.
Collaborative working: This is a collaborative endeavour that aims to expedite clinical translation of the technology for the benefit of all stakeholders, including product developers, regulatory authorities, public health bodies and end-users.
Activities: We have parallel work streams that aim to:
(1) define the MAP dosage form
(2) identify and understand MAP critical quality attributes (CQAs)
(3) develop standardised validated test methods to evaluate the quality of finished MAP products and/or the development of pre-clinical prototypes
(4) inform the microbiological requirements for MAP products.
Collaborative working: This is a collaborative endeavour that aims to expedite clinical translation of the technology for the benefit of all stakeholders, including product developers, regulatory authorities, public health bodies and end-users.
Activities: We have parallel work streams that aim to:
(1) define the MAP dosage form
(2) identify and understand MAP critical quality attributes (CQAs)
(3) develop standardised validated test methods to evaluate the quality of finished MAP products and/or the development of pre-clinical prototypes
(4) inform the microbiological requirements for MAP products.
Background: The MAP-RWG was formed as part of the Center of Excellence for MAP technology, an 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 co-Chair a group that 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.
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RWG co-chairs, attending members and observers during a face-to-face meeting in July 2019 (PATH, Seattle, USA)
Organisations that have previously been represented on the group include: Corium, Radius, Zosano Pharma and 3M.
Page updated 17 September 2023
