Pharmaceutical Quality Knowledge Management System (PQKMS)
19 March 2025
Extension of the ICMRA PQKM Collaborative Pilots
ICMRA has extended its Pharmaceutical Quality Knowledge Management (PQKM) collaborative pilot programs, comprising the Collaborative Assessment Pilot and the Collaborative Hybrid Inspection Pilot until the end of 2025. The pilots will continue to accept applications throughout the year to gather further experience with these innovative regulatory approaches.
13 March 2025
ICMRA Collaborative Hybrid Inspection Pilot Summary Report
Ensuring medicine supply at the global scale is a complex task which requires, among other things, regulatory approvals from multiple regulatory authorities with different requirements and approval timelines. This complexity can delay the timely availability of medicines for patients worldwide. To address this challenge, the International Coalition of Medicines Regulatory Authorities (ICMRA) launched the Collaborative Hybrid Inspection Pilot (CHIP) in 2021. The pilot aimed to enable industry participants (or sponsors) to submit a single Chemistry, Manufacturing, and Controls (CMC) submission to increase manufacturing capacity, and that could undergo simultaneous inspection by multiple regulatory authorities in a hybrid format. Key objectives included enhancing regulatory collaboration, reducing duplication in assessments, and improving medicine availability. Several regulatory authorities, including the US FDA, EMA, MHRA, Swissmedic, Health Canada, ANVISA, MOH Israel, PMDA and HPRA took part either as full participants or observers.
The ICMRA CHIP successfully completed three inspections involving a variety of medicinal products and post-approval changes. There was consensus on inspection findings and compliance outcomes for all three pilot inspections. Participating authorities agreed on the manufacturers’ corrective and preventive action (CAPA) plans and any post-inspection information requests. Importantly, the pilot demonstrated that meaningful collaboration is achievable under existing regional legal frameworks without introducing additional regulatory burdens or delays. The success of the initiative highlights the value of knowledge sharing and collaboration between global regulatory authorities in expediting access to essential medicines. This progress report provides an overview of the outcomes of the pilot and proposals for next steps.
23 January 2025
ICMRA Collaborative Assessment Pilot Summary Report
Ensuring medicine supply at the global scale is a complex task which requires, among other things, regulatory approvals from multiple regulatory authorities with different requirements and approval timelines. This complexity can delay the timely availability of medicines for patients worldwide. To address this challenge, the International Coalition of Medicines Regulatory Authorities (ICMRA) launched the Collaborative Assessment Pilot in 2021. The pilot aimed to align the scientific evaluation of Chemistry, Manufacturing, and Controls (CMC) Post-Approval Change Management Protocol (PACMP) submissions across multiple regulatory authorities and reach the same risk-based recommendations or conclusion. The pilot involved several global medicine regulators, including EMA, FDA, PMDA, MHRA, Swissmedic, Health Canada, ANVISA, TGA, and HSA. Key objectives included enhancing regulatory collaboration, reducing duplication in assessments, and improving medicine availability.
Through a collaborative review process, participating authorities achieved 88% consensus on technical questions related to CMC or pharmaceutical quality data. Harmonized information requests ensured alignment and minimised redundancies. All applications were completed within a standardised 120-day timeline, with synchronised approval dates across regions. Industry participants reported a positive experience, though regulators faced an increased workload due to consensus-building efforts and coordination. Importantly, the pilot demonstrated that meaningful collaboration is achievable under existing regional legal frameworks without introducing additional regulatory burdens or delays. The success of the initiative highlights the value of knowledge sharing and collaboration between global regulatory authorities in expediting access to essential medicines. This progress report provides an overview of the outcome of the pilot and proposals for next steps.
25 October 2024
ICMRA-ICH-IPRP-PICS Joint Work Plan for Harmonisation and Convergence Work to Advance Development of a Regulatory Pharmaceutical Quality Knowledge Management Capability
In July 2022, ICMRA, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the International Pharmaceutical Regulators Programme (IPRP) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) published a joint reflection paper. The paper outlined the coordinated, multi-stakeholder approach to harmonisation work required to support the development of a regulatory Pharmaceutical Quality Knowledge Management (PQKM) capability. ICMRA, ICH, IPRP and PIC/S committed to developing a multi-year work plan. Its first iteration [PDF] was published in December 2023.
The joint work plan has been revised to include updated information on the status of the various initiatives underway within each of the four organisations. Additionally, the updated work plan [PDF] includes information on relevant developments across each organisation, including:
ICH: Establishment of the PQKM Technology Platform Task Force
IPRP: Addition of a planned literature review of recent post-approval change-related publications from industry as part of ongoing work to identify potential opportunities for convergence for quality post-approval changes and variations
PIC/S: New project plans being advanced by the PIC/S Working Group on Inspection Reliance to support promotion of use and reliance on good manufacturing practice inspectional information
ICMRA PQKM Working Group: Publication of a progress report on Identifiers to Enable Pharmaceutical Quality Knowledge Management
17 July 2024
Identifiers to enable a pharmaceutical quality knowledge management capability
A key challenge that must be addressed in establishing a pharmaceutical quality knowledge management (PQKM) capability is the ability to identify or confirm that it is the same product under assessment by different regulatory authorities in parallel or at different times. Although some authorities use national or regional identifiers, a common and interoperable limited set of identifiers for manufacturing facilities, pharmaceutical products, substances, marketing applications, and/or marketing application holders is not currently endorsed. As part of the PQKM project, a group composed of representatives from multiple regulatory authorities was convened to consider relevant standards and identifiers. This progress report provides an overview of the initial activities and work undertaken by the group, alongside relevant international developments and high-level proposals for next steps.
Update: 12 June 2024
PQ KMS Pilot Updates
In the interests of transparency and to ensure key stakeholders are informed, the pages below 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.
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).
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
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
- 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]