ICMRA explores hybrid inspections, postapproval changes with new pilots
A global regulatory group is seeking industry participants for two pilot programs exploring a common regulatory framework for assessing manufacturing facilities in hybrid inspections and for reviewing postapproval changes.The International Coalition of Medicines Regulatory Authorities (ICMRA) announced the pilots on 24 June. The group said that the pilots were prompted by its July workshop which “highlighted the need for more convergence on CMC [chemistry, manufacturing, and controls] aspects between regions to allow faster supply of critical medicines to patients and the need to overcome travel logistical challenges created by the pandemic through use of hybrid inspections.” (RELATED: ICMRA: Industry’s commitment to quality can facilitate regulatory flexibility, Regulatory Focus 12 October 2021).
The meeting was attended by upwards of 400 delegates from more than 30 global regulators, as well as representatives from the pharmaceutical industry.
The pilots are open to sponsors planning to file new product applications or applications for postapproval changes and covers both small molecule and large molecule products.
The objectives of the pilots are to develop a common framework for “collaborative assessments and hybrid inspections,” and to “identify best practices in assessing CMC-related postapproval changes” for quality assessments, said ICMRA.
The pilots also aim to identify any “misalignments, differences, and potential areas for alignment or harmonization across participating regulators’ regions.” Manufacturers’ responses will be shared with the quality assessors who will then “work towards a common approach to assessments and decision making.”
The pilots are expected to run for one year, and a report on these outcomes is expected in 2023.
The effort also builds on other ongoing industry initiatives, including an industry consortium that is working on a structured content cloud-based CMC module 3 template with input from regulator. The program was discussed at the Drug Information Association (DIA) meeting in Chicago last week. (RELATED: DIA: Global Initiative to standardize CMC quality data gaining steam, Regulatory Focus 22 June 2022)
Best practices for hybrid inspections
The inspection pilot aims to explore collaborative facility assessments using both onsite inspections and virtual technology to “identify best practices to prepare and conduct the hybrid inspection to ensure that both on-site and distant inspectorates obtain the desired information to complete respective assessments and meet their objectives.”
It also aims to “identify misalignment, differences, and potential areas for alignment in GMP expectations – one area of focus here might be in how the inspection is reported and how deficiencies are classified.”
The pilot aims to deliver a protocol describing how to execute hybrid inspections, and how to prepare and execute hybrid inspections. (RELATED: ICMRA: Remote inspections can complement, but not replace, onsite inspections, Regulatory Focus 14 December 2021)
Once the protocol is approved, it will be used to evaluate between three to five facilities involving at least two regulatory agencies.
Collaborative assessments for postapproval changes
The CMC pilot aims to “conduct collaborative quality assessment for COVID-19 related postapproval CMC changes” including postapproval change management protocols (PACMPs). It will initially focus on COVID-19 therapeutics and may be extended to other products.
The pilot also seeks to identify best practices in assessing postapproval changes, and to identify “misalignments” in harmonizing requirements for these changes, and to collaborate with industry members interested in submitting a global filing.
The goal is to run collaborative quality assessments for at least three applications involving three regulators.
ICMRA wants to start both pilots in September 2022.
The US Food and Drug Administration (FDA), which is a member of ICMRA, also announced a call for participants.
ICMRA
