Pharmaceutical Quality Knowledge Management System (PQKMS)
8 December 2023
Combined Work Plan for Harmonisation and Convergence Work to Advance Development of a Regulatory Pharmaceutical Quality Knowledge Management Capability
In 2022, 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) shared their vision for the development of a global pharmaceutical quality knowledge management (PQKM) capability in a joint reflection paper. As this work continues to progress, the four organisations have developed a combined multi-year work plan [PDF] to enable further refinement of the prioritisation and sequencing of how relevant workstreams should proceed within each organisation.
Update: 8 December 2023
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, the presentations delivered on the day, a recording of day one of the workshop, and a brief summary report of the workshop.
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).
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.
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.
Statement in other languages
- Arabic - بيان التحالف الدولي حول إدارة معرفة الجودة الصيدلانية العالمية لتعزيز الاعتماد التنظيمي ومرونة التنفيذ
- French - Gestion globale des connaissances sur la qualité des produits pharmaceutiques : Améliorer la fiabilité et l’agilité de la réglementation [PDF]
- Japanese - グローバルな医薬品品質知識管理: レギュラトリー・リライアンスとアジリティの向上 [PDF]