Pharmaceutical Quality Knowledge Management System (PQKMS)

 

31 August 2023

ICMRA-industry virtual workshop on Development of a Pharmaceutical Quality Knowledge Management System


On 20 and 21 July 2023, ICMRA and IFPMA hosted a joint virtual workshop on the development of a global Pharmaceutical Quality Knowledge Management System (PQKMS). The workshop highlighted some of the progress made in developing collaborative approaches to medicines regulation since the ICMRA workshop on enabling manufacturing capacity in the COVID-19 pandemic held in July 2021.

The ICMRA PQKMS project aims to leverage collective resources and information sharing between regulatory agencies. This will be achieved through the alignment of applications data submissions, expectations, and assessments, as well as inspections. In turn, this will help to significantly reduce the need for multiple separate submissions from sponsors, avoid duplicative assessments, and facilitate inspection reliance. As part of this project, ICMRA is overseeing two pilot programmes on collaborative assessments of post-approval changes and hybrid inspections by multiple regulatory authorities.

During the workshop, both industry and regulators shared feedback on their experiences with the ongoing pilots, highlighting the successes and the challenges. Participants explored barriers to involvement in the pilots, as well as practicable solutions to those barriers. Panellists also discussed future direction and planning for the PQKMS project, including what they believed to be the enormous potential of the project.

Here you can find a copy of the workshop agenda and the presentations delivered on the day, along with a recording of day one of the workshop. A brief summary report of the workshop is under preparation and will be published on the ICMRA website in due course.

Agenda

Presentation

Video recording

 

Update: 31 August 2023
17 June 2022

PQKMS Collaborative Pilot Information and Application Forms

Following the July 2021 ICMRA-Industry virtual workshop on enabling manufacturing capacity in the COVID-19 pandemic, ICMRA is commencing two pilot programs focusing on i) collaborative assessment with initial focus on chemistry, manufacturing, and  control (CMC) post-approval changes and ii) collaborative hybrid inspections. The overall aim of these pilots is to improve manufacturing capacity for production of critical medicines and facilitate collaborative assessments and inspections by multiple regulatory authorities (see links for further information).

Call for Applications to PQ Pilots 

Application Form for Collaborative Assessment

Application Form for Collaborative Hybrid Inspection

Overview of Collaborative Assessment

Overall Plan for Collaborative Assessment

Overview of Hybrid Inspection

Overall Plan for Hybrid Inspection

Inspection Expectations for CHIP Participants [PDF]

 

16 December 2022

PQ KMS Pilot Updates

In the interests of transparency and to ensure key stakeholders are informed, the current page will provide regular updates on the current status of each collaborative pilot. Further information will also be provided on the rationale for choosing specific applications to participate in each pilot.

Collaborative Pilot Update: 16 December 2022

 

19 August 2022

A Regulatory Pharmaceutical Quality Knowledge Management System (PQ KMS) to Enhance the Availability of Quality Medicines

The International Coalition of Medicines Regulatory Authorities (ICMRA), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), International Pharmaceutical Regulators Programme (IPRP) and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are working to harmonise pharmaceutical quality knowledge management to improve the availability of high-quality medicines. Their shared vision for the development of a global pharmaceutical quality knowledge management system (PQ KMS) is outlined in a joint reflection paper [PDF].

 

11 June 2021

The International Coalition of Medicines Regulatory Authorities (ICMRA) has developed a joint statement on the establishment of a pharmaceutical quality knowledge management system, which could help to better inform both public and industry stakeholders on the coalition’s efforts to improve global regulatory harmonisation and alignment.
 
Regulatory authorities can gain efficiencies by developing common procedures, guidelines, requirements, and interoperable infrastructure that would facilitate the timely sharing of information on changes occurring within the supply chain of medicines. This may include reliance on the assessments of other regulators but could lead to more timely availability of medicines for patients by shortening approval timelines.

Following an initial period of consultation with the broader ICMRA membership, the ICMRA Executive Committee formally established a PQ KMS Working-Group with specific responsibility for advancing efforts needed to develop a PQ KMS capability.

 

PQKMS Statement

Global Pharmaceutical Quality Knowledge Management: Enhancing Regulatory Reliance and Agility [PDF]

Statement in other languages