overview_of_collaborative_assessment.pdf

overview_of_collaborative_assessment.pdf International pilot programmes to streamline regulatory assessments and inspections – call for industry applications FDA, as a Member of the International Coalition of Medicines Regulatory Authorities (ICMRA), is pleased to share the announcement of the following new pilot programs and the call for industry applications. ICMRA is inviting industry sponsors to participate in pilot programmes focusing on i) collaborative assessments of chemistry, manufacturing and control (CMC) related post-approval changes and ii) hybrid inspections[1]. The main objectives of the two pilots include: Development of an initial common framework for collaborative assessment and hybrid inspections; Identification of best practices and standards in the quality assessment of CMC-related post-approval changes and collaborative hybrid inspections to inform relevant quality assessments; Delivery of a single list of questions to the sponsor or manufacturer, wherever possible, and identification of any misalignments, differences, and potential areas for alignment or harmonization across participating regulators’ regions; Sharing of the sponsors’ or manufacturer’s responses with the participating quality assessors/inspectors who will work towards a common approach to assessment and decision making; Identification of the conditions (products/ cases) on which cross-regional collaboration efforts in the collaborative assessment and hybrid inspection pilots should focus and the development of recommendations for a future cross-regional pathway(s) to be pursued by ICMRA. Each pilot will involve at least two regions that will conduct three assessments or collaborative hybrid inspections. Both pilots are expected to last for one year. A report summarising the key outcomes, lessons learnt and recommendations will be published after the end of the pilot programs in 2023. The launch of these pilots builds on the discussions held during a workshop on expansion of manufacturing capacity for COVID-19 therapeutics and vaccines organised by ICMRA in July 2021. Meeting participants, including more than 400 delegates from over 30 medicines regulatory authorities globally, as well as experts from the pharmaceutical industry, discussed the need for more convergence and reliance to allow faster supply of critical medicines to patients and the need to overcome logistical challenges posed by the pandemic through the use of hybrid inspections. Further information on the two collaborative pilots, key considerations and the application procedure is available on the ICMRA website. For inquiries related to participation in the pilots E-mail: icmra-pac-pilot@fda.hhs.gov All other inquiries E-mail: cdersbia@fda.hhs.gov