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.
The first full publication from the group aims to identify the pertinent features of MAP products that should be considered when assessing the risk of infection and share their expert opinions and experiences with the scientific community. The published findings of this work can be accessed HERE (Journal of Controlled Release), and will hopefully help to inform microbiological risk assessments for emerging MAP products.
We are in the process of drafting and article that considers (i) the nomenclature and definition of the MAP dosage form and (ii) MAP CQAs and associated standardized test methods (aiming to publish in second half of 2024).
We are in the process of drafting and article that considers (i) the nomenclature and definition of the MAP dosage form and (ii) MAP CQAs and associated standardized test methods (aiming to publish in second half of 2024).
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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 22 July 2024
