Extension of the ICMRA PQKM Collaborative Pilots

2025 Pilot Extension

The ICMRA Pharmaceutical Quality Knowledge Management (PQKM) collaborative pilot programs, comprising the Collaborative Assessment Pilot and the Collaborative Hybrid Inspection Pilot, have been extended. The pilots will continue to accept applications until the end of 2025, with the aim of taking no more than five cases per pilot, per year.

As the pilots will focus on a small number of applications, it is essential that the most appropriate cases are chosen to deliver meaningful results. Given the resource requirements for collaborative assessments and hybrid inspections of this nature, future proposals should consider the following.

Collaborative Assessment Pilot

  • The pilot’s alignment with the PQKM project scope remains unchanged, aiming to facilitate timely approvals to strengthen supply of critical medicines. Details can be found in the Overall Plan for the Collaborative Assessment Pilot.
  • Proposals should be for high-impact changes for medically important treatments, including generic drugs and biosimilars, and applications which will have a positive impact on medicine supply and support manufacturing innovations that could strengthen supply of critical medicines.
  • Proposals should contain clear justification for the measurable impact on supply and explain why the proposal should be prioritized for inclusion in the pilot.


Collaborative Hybrid Inspection Pilot

  • Priority will be given to those proposals that have a measurable, positive impact on global supply and public health. Details can be found in the Overall Plan for Hybrid Inspection.
  • Proposals should be for changes for medically important treatments, including generic drugs and biosimilar products, and support manufacturing innovations that could strengthen supply of medicinal products.
  • Proposals with sites that allow two or more Regulatory Authorities to participate, not being limited by mutual recognition agreements, will be prioritized.
  • The Collaborative Hybrid Inspection Pilot continues to focus on sites requiring an inspection to support submissions of manufacturing changes but will also consider sites where at least two participating authorities have a common interest for a pre-approval inspection.


Further information on both pilots and relevant application forms can be found through the following links:

Applicants are encouraged to contact the PQKM Pilot Coordination Group to discuss potential future applications through the following email addresses:

 

2025 Goals and Milestones for the PQKM Collaborative Pilots

  • Continue to identify areas within the collaborative regulatory assessment and inspection processes where efficiency could be improved to reduce resources needed.
  • Amend the current product selection criteria to allow for submission of post-approval applications for a broader range of products (e.g. generics and biosimilars).
  • Work with the ICH PQKM Technology Platform Task Force to provide lessons learned to support the development of a secure technology platform for the PQKM capability. 
  • Increase participation from additional ICMRA regulatory authorities, whenever appropriate.
  • A public PQKM Pilots workshop is planned for the summer of 2025.

 

Recent Accomplishments of the PQKM Collaborative Pilots

  • The Collaborative Assessment Pilot agreed a process with a standard 120-day timetable.
  • Agreement on data requirements across numerous areas of CMC and majority of information requests were harmonized. 
  • The majority of Collaborative Assessment Pilots received simultaneous (same-day) approval in multiple regions. 
  • Collaborative hybrid inspections were successfully completed without technical difficulties.
  • Survey feedback from sponsors indicated an overall positive experience with the pilots and highlighted areas of further development and improvement for the next set of applications of collaborative assessments and collaborative hybrid inspections.
  • The Collaborative Assessment Pilot Summary Report was published in January 2025.
  • The Collaborative Hybrid Inspection Pilot Summary Report was published in March 2025.