ICH exploring global platform for reviewing post approval CMC changes
A working group from the International Council for Harmonisation (ICH) is evaluating the establishment of a global, secure technology platform for regulators. This platform would facilitate the joint review of post-approval changes in chemistry, manufacturing, and controls (CMC) that the industry requests for currently marketed drug products.On Thursday, ICH's Pharmaceutical Quality Knowledge Management (PQKM) task force issued a request for information (RFI) seeking input from vendors who can develop such a platform.
The RFI seeks feedback on an approach for implementing a “scalable technology solution that facilitates secure global multi-regulatory collaborative assessments. It is anticipated that if implemented, the resulting solution would create a global, secure collaborative platform for regulatory authorities which may prospectively facilitate a collaborative assessment process including interactions with sponsors.”
The project involves creating a post-approval CMC submission platform, with the potential to expand into other regulatory activities.
The RFI builds on previous initiatives aimed at establishing global reviews for post-approval changes. In June 2022, the International Coalition of Medicines Regulatory Authorities (ICMRA) invited industry participants to join two pilot programs: one focused on developing a common regulatory framework for assessing manufacturing facilities during hybrid inspections, and the other aimed at reviewing post-approval changes (RELATED: ICMRA explores hybrid inspections and post-approval changes with new pilots, Regulatory Focus, 29 June 2022).
The task force's work aligns with other initiatives from the ICH aimed at standardizing technical and scientific requirements for pharmaceutical registration. This includes the ICH M8 initiative, which focuses on the electronic Common Technical Document (eCTD) Version 4, as well as the upcoming ICH guidelines on Structured Product Quality Submissions (SPQS). Additionally, it includes ICH Q10, which addresses pharmaceutical quality systems, and ICH Q12, which focuses on managing post-approval changes.
Prior to the adoption of ICH Q12 in November 2019, there was a lack of alignment in reporting post-approval changes, which hindered innovation in the pharmaceutical sector.
The task force stated that the system would be managed by a trusted third party instead of a single regulatory authority or sponsor. This trusted third party should be capable of meeting the needs of both sponsors and regulatory authorities while also considering the broad requirements of a wide range of stakeholders.
The task force has proposed a phased implementation of the system. Phase zero involves continuing with the current system, which utilizes a collaborative file-sharing tool. In the first phase, the plan is to centralize this system under a governing body and to establish formal governance and technical capabilities.
The second phase will implement “more robust technology for quality submission management, process tracking, reporting, and improved data sharing by incorporating ICH requirements such as M4Q(R2) and potentially SPQS.”
Once these systems are fully established, advanced technologies like artificial intelligence (AI) can be introduced “to help reduce time and improve quality as the solution progresses into later phases of maturity and extended use.”
The RFI states that “the evolution from phase to phase will be determined and guided by direction of the participating regulatory authorities.”
The task force proposes three types of users for the system: the sponsor who would initiate the submission process with the legacy systems of the regional regulatory authorities; the lead regulator who would be responsible for managing the submission milestones and consolidating all questions from the participating regulatory authorities to the sponsors; and the participating regulator who would collaborate with the lead regulator and other participating regulatory authorities to conduct the regulatory pharmaceutical quality assessment of the post-approval CMC submissions.
Some of the areas for input are:
- Whether a phased approach is necessary or if an alternative phased approach and timeline should be considered;
- A recommended target solution architecture for the system considering desired capabilities and existing constraints with respect to existing national and regional laws, regulations, and security policies;
- The approach for handling data protection, information security, and records management,
- The approach for complying with various privacy, cyber, and data residency requirements of stakeholders, particularly regional regulatory authorities,
- Whether there is an existing solution that would meet all or some of the identified capabilities without the need for custom development; and
- Whether the provider has implemented similar solutions before, and if so, the challenges in implementing similar solutions
The deadline for submitting information is 8 January. Responses should be sent here: [email protected]
RFI
×
Welcome to the new RAPS Digital Experience
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.
We welcome your feedback. Please let us know how we can continue to improve your experience.