On 20 July 2023, a virtual workshop was held to discuss progress made in the development of a PQ KMS. The workshop was jointly organised by the International Coalition of Medicines Regulatory Authorities (ICMRA) and industry representatives under the International Federation of Pharmaceutical Manufacturers and Traders (IFPMA)

During the workshop, participants explored collaborative approaches to support alignment of regulatory requirements to ensure the quality of pharmaceutical products. A summary report of the workshop has been published, outlining progress made as part of ICMRA’s PQ KMS project and initial key learnings from its two pilot programmes, with perspectives from regulators and industry representatives.

The pilots focus on two essential parts of medicines evaluation: collaborative assessments of post-approval changes and hybrid inspections. Building on lessons from the COVID-19 pandemic, the goal is to significantly reduce the need for multiple submissions from companies, avoid duplicative assessments by regulators, and facilitate inspection reliance to build stronger global resilience.

The collaborative assessment pilot aims to enable greater cross-regional access to high-quality, critical medicines through parallel assessments and approvals in different regions. Regulators are afforded the opportunity to develop reliable mechanisms and approaches that enhance regulatory convergence, mutual recognition and trust.

In May 2023, the pilot reached a milestone when EMA and the United States Food and Drug Administration (FDA), with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) as an observer, agreed simultaneously on how a pharmaceutical company could add three new manufacturing sites in the supply chain of Lunsumio, a treatment for a rare type of cancer.

Overall, this first completed pilot case shows how all parties worked together to reach a single agreed outcome and provides valuable learnings. According to participants, the pilot brought significant benefits, with same-day approval from both FDA and EMA, with no delays to timelines and no significant additional workload. Work continues to further develop and optimise logistical and technological requirements to support collaborative assessments.

Next steps for the pilot include completing further pilot cases, with involvement of additional regulators. According to regulators, the pilot could indicate how regulators and industry could best work together to implement and promote innovative regulatory approaches and technologies.

Hybrid inspections allow multiple regulators to participate in an inspection either on-site or remotely and take one joint regulatory decision. The ICMRA collaborative hybrid inspection pilot (CHIP) explores how existing technologies and virtual inspection methods can support stronger collaboration among regulators and maximise the use of limited resources. Next steps include continued testing of the approach in multiple pilot cases and discussing how to expand the programme further.

The pilot is open for new applications from industry. To support potential applicants, ICMRA has published a paper on inspection expectations for CHIP participants, which outlines benefits, requirements and processes for hybrid inspections and complements information provided in the overall plan for hybrid inspection.

Notes

  1. The summary report of the PQ KMS workshop and further information on the PQ KMS project, including the agenda, video recording and presentation from the workshop held on 20 July 2023, is available on the ICMRA website
  2. ICMRA-ICH-IPRP-PICS Joint work plan for harmonisation and convergence work to advance development of a regulatory pharmaceutical quality knowledge management capability

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