Meetings

The thirteenth meeting of the Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) was held on the 5^th and 6^th of June 2024 in Fukuoka, Japan. 29 IPRP Members and Observers were represented at the meeting. Dr. Asmaa Fouad from EDA, Egypt was elected as the new IPRP MC Vice-Chair, replacing Mr. Teruyoshi Ehara from MHLW/PMDA, Japan, to serve for a two year term from the end of the Fukuoka meeting, alongside the current IPRP Chair Dr. Petra Doerr from EDQM.

The following IPRP Working Groups (WGs) provided reports on their achievements over the past months and their future activities: Identification of Medicinal Products (IDMP); Nanomedicines; Cell & Gene Therapy; Biosimilars; Bioequivalence for Generics; and Quality. The updates included: news from the Bioequivalance WG for Generics regarding the publication in March 2024 of an article on “Bioequivalence Study Designs” in the Journal of Pharmacy & Pharmaceutical Sciences; work on a summary report, for publication shortly on the IPRP website, by the Biosimilars WG on the September 2023 workshop on “Increasing the Efficiency of Biosimilar Development Programs—Reevaluating the Need for Comparative Clinical Efficacy Studies”; and Quality WG involvement with activities of the International Coalition of Medicines Regulatory Authorities (ICMRA) Pharmaceutical Quality Knowledge Management System (PQ KMS) Working Group.

The MC also discussed a number of Focus topics at the Fukuoka meeting. These included:

• Patient-orientated and electronic product information;
• Experiences in the Implementation of ICH Guidelines, with discussion of the outcome of the recent survey conducted by ICH (via a third-party survey provider) to assess the current level of implementation and adherence to ICH Guidelines within Regulatory Member and Observer countries/regions, many of who are also represented at IPRP;
• Reliance practices and cooperation;
• Artificial Intelligence (AI) in medical products development, with presentation on the 2024 AI Regulatory and International Symposium (AIRIS) held in February 2024 in Seoul, Republic of Korea, co-hosted by MFDS, Republic of Korea and FDA, United States.

The MC also spent time in Fukuoka to discuss IPRP’s strategic vision and stakeholder engagement plan, reviewing input collected in a survey conducted of IPRP Members and Observers, as well as external stakeholders. The MC will reflect on the outcome of the survey which will be used to inform the future strategic direction of IPRP.

Finally, the MC also received a number of regulatory updates from IPRP Members and Observers.

The next meeting the IPRP MC is planned for the 6^th and 7^th November 2024 in Montréal, Canada.

The twelfth meeting of the Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) was held on the 1^st and 2^nd of November 2023 Prague, Czech Republic. 29 IPRP Members and Observers were represented at the meeting. The MC welcomed two new IPRP MC Members: The Algerian Regulatory Authority – ANPP, Algeria; and the Jordanian Regulatory Authority – JFDA, Jordan.

The following IPRP Working Groups (WGs) provided reports on their achievements over the past months and their future activities: Nanomedicines; Cell & Gene Therapy; Identification of Medicinal Products (IDMP); Quality; Biosimilars; and Bioequivalence for Generics. Of note was the virtual Biosimilars WG workshop held in September 2023 on Increasing the Efficiency of Biosimilar Development Programs—Reevaluating the Need for Comparative Clinical Efficacy Studies. The MC noted that the public session of the workshop was very well attended, with close to 1,700 registrants and that the presentations, as well as a recording of the workshop would be made available shortly on the IPRP website.

The MC also discussed a number of Focus topics at the Prague meeting. These included:

• Use of Artificial Intelligence in medicines development;
• Experiences with implementation of ICH Guidelines, including a country experience from COFEPRIS, Mexico;
• Reliance, including an update on the WHO Listed Authority (WLA) initiative;
• e-Labelling and e-statutory information of medicinal products.

Other important topics, which the IPRP MC was updated on, included the ongoing work of the International Coalition of Medicines Regulatory Authorities (ICMRA) Pharmaceutical Quality Knowledge Management System (PQ KMS) Working Group, with which IPRP is working, alongside the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) to harmonise pharmaceutical quality knowledge management to improve the availability of high-quality medicines.

At the next meeting the IPRP MC will discuss the revision of the IPRP Strategic Framework, including the IPRP Stakeholder Engagement Plan, besides the continuing topics. The meeting is planned for the 5^th and 6^th June 2024 in Fukuoka, Japan.

The eleventh meeting of the Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) was held on the 13^th and 14^th June 2023 in Vancouver, Canada. 23 IPRP Members and Observers were represented at the meeting. The MC welcomed the Nigerian Drug Authority – NAFDAC, Nigeria as a new IPRP Member. Dr. Petra Doerr from EDQM and Mr. Teruyoshi Ehara from MHLW/PMDA, Japan were elected as new IPRP MC Chair and Vice-Chair to serve for two and one year terms rexpectively.

The following IPRP Working Groups (WGs) provided reports on their achievements over the past months and their future activities: Nanomedicines; Cell Therapy; Gene Therapy; Identification of Medicinal Products (IDMP); Quality; Biosimilars; and Bioequivalence for Generics. Of note was the IPRP MC support for the merging of the Cell Therapy and Gene Therapy WGs moving forward, as well as IPRP MC support for the organization of a virtual public workshop by the Biosimilars WG on 12^th and 13^th September 2023 on Increasing the Efficiency of Biosimilar Development Programs – Re-evaluating the Need for Comparative Clinical Efficacy Studies. Details will be made available on the IPRP website.

The following were discussed as Focus topics discussed at the meeting:

• Experiences with implementation of ICH Guidelines, including the recent Q12 Lifecycle Management Guideline, as well the Q5E and E6(R2) Guidelines;
• Electronic product information (ePI) and future vision for ePI in regulatory processes in Europe;
• A Member experience on Digitalization of Risk Communication;
• Experiences regarding patient stakeholder engagement, and work to collect patient experiences towards enhancing meaningful outcomes;
• Finally, an update to the IPRP Questions & Answers document on Reliance was confirmed for publication on the IPRP website.

The IPRP MC was also updated on the important work, including ongoing pilots, of the International Coalition of Medicines Regulatory Authorities (ICMRA) Pharmaceutical Quality Knowledge Management System (PQ KMS) Working Group, with which IPRP is working, alongside the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) to harmonise pharmaceutical quality knowledge management to improve the availability of high-quality medicines.

The next IPRP MC meeting is planned for the 1^st and 2^nd November 2023 in Prague, Czech Republic.

The tenth meeting of the Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) was held on the 16^th and 17^th of November 2022, Incheon, Republic of Korea. 25 IPRP Members and Observers were represented at the meeting.

IPRP’s 8 Working Groups (WGs): Nanomedicines; Cell Therapy; Gene Therapy; Identification of Medicinal Products (IDMP); Quality; Biosimilars; Bioequivalence for Generics; and Pharmacovigilance, provided a report to the MC on their achievements over the past months and their future activities.

Focus topics: Reliance; Experiences in the Implementation of ICH Guidelines; Experience Sharing on Patient Engagement; and statutory electronic product Information of Medicinal Products were discussed at the meeting:

• The IPRP MC discussed the important topic of sameness of medicinal product in the context of reliance. The verification of sameness (as defined in the WHO Good Reliance Practices document) is an essential step for any reliance approaches in order to check that the product for which a dossier has been received by the relying authority has  “identical essential characteristics”  as the one received by the reference authority. Regarding manufacturing sites as they constitute key quality attributes for the medical product, the expectation from regulators is that the product should have the same manufacturing site(s) reviewed by the reference authority. Per WHO Good Reliance Practices, any differences between the dossier submitted to the reference authority and the relying authority should be clearly identified upfront by the manufacturer/marketing authorization holder and should be assessed by the National Regulatory Authority;
• The IPRP MC Members shared their experiences with implementation of ICH Guidelines, with specific focus on Quality, including the older Q1 ICH Stability Guidelines and the more recent Q12 Lifecycle Management Guideline. Regarding Q12, Regulators shared similar experiences, including stepwise approaches to implementation and training considerations;
• The IPRP MC Members also shared experiences regarding patient stakeholder engagement, including approaches for engagement of patients in different scenarios, such as during the pandemic which highlighted the importance of communication in a non-technical way;
• The IPRP MC was also informed on the latest technical advances in Europe on e-Labelling and electronic product information (ePI) under Health Level Seven’s (HL7’s) Fast Healthcare Interoperability Resources (FHIR), and the broader use of FHIR as a common technical standard for structuring and exchanging product information.

Finally, the MC also discussed a new topic on using Artificial Intelligence (AI) to Monitor Products Sold Online, and also received a number of regulatory updates from IPRP Members.

The next IPRP MC meeting is planned for the 13^th and 14^th of June 2022 and is foreseen to be held in Vancouver, Canada.

The ninth meeting of the Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) was held on the 25^th and 26^th of May 2022 in Athens, Greece. 23 IPRP Members and Observers were represented at the meeting, which was organised in a hybrid format with both in-person and virtual participation. The MC welcomed the Egyptian Drug Authority – EDA, Egypt as a new IPRP Member. Dr. Peter Bachmann from EC, Europe and Mr. Diogo Penha Soares from ANVISA, Brazil were re-elected as IPRP MC Chair and Vice-Chair respectively, to serve for another 1-year term from the end of the meeting.

IPRP’s 8 Working Groups (WGs) provided a report to the MC on, respectively: Nanomedicines; Cell Therapy; Gene Therapy; Identification of Medicinal Products (IDMP); Quality; Biosimilars; Bioequivalence for Generics; and Pharmacovigilance, presenting their achievements over the past months and their future activities. The MC endorsed publication of an article from the Working Group on Bioequivalence for Generics on “A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme”.

Focus topics of MC discussion at the meeting included: Reliance; e-Labelling; Environmental Risk Assessment; Challenges in the Implementation of ICH Guidelines; and a new focus topic regarding the Sharing of Experience on Patient Engagement.

• Regarding Reliance, the MC provided support in principle for a Questions and Answers document for publication on the IPRP website that will explain the importance of reliance for the regulatory oversight of medical products working with WHO.
• On the topic of e-labelling, the MC noted development of an article informed by the results of the recent survey conducted amongst IPRP parties. The article entitled “Electronic product information for human medicines; current situation and future projection: based on surveys of regulatory agencies in IPRP countries/regions” is planned for publication shortly with financial support for its publication from IPRP as a first case.
• The results of the Environmental Risk Assessment survey amongst IPRP parties in relation to medicinal products were also discussed by the MC, with parties sharing information on requirements in their respective countries/regions.
• The MC also shared experiences regarding approaches to learning about patient’s experience with their disease and available treatments, and ways in which patients are engaged to inform regulatory decision making on products to treat that disease.
• The IPRP Members shared their experiences with implementation of ICH Guidelines and agreed an approach for the next meeting to facilitate further discussion of experiences.
• Finally, the IPRP Members shared significant recent regulatory updates.

The next IPRP MC meeting is planned for the 16^th and 17^th of November 2022 and is foreseen to be held in person in Incheon, Republic of Korea.

The eighth meeting of the Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) was held on the 19^th and 22^th of November 2021. 24 IPRP Members and Observers were represented in the meeting, which was organised in a virtual setting in view of the COVID-19 pandemic.

As usual in IPRP MC meetings, the 8 IPRP Working Groups (WGs) provided a report to the MC on, respectively, Nanomedicines, Cell Therapy, Gene Therapy, Identification of Medicinal Products (IDMP), Quality, Biosimilars, Bioequivalence for Generics, and Pharmacovigilance, presenting their achievements over the past months and their future activities. The MC endorsed the publication drafted by the Quality WG on Survey on Administrative Procedures and Terminologies for Quality Variations/Post-approval Changes. This paper will assist in clarifying differences in Regulators’ terminologies and procedural aspects and aims to increase an understanding of the procedures used for changes to APIs and drug products (e.g., categories/levels) for both regulators and the pharmaceutical industry, and will be available shortly on the IPRP website. Additionally, the Frequently Asked Questions (FAQ) document of the IDMP WG was updated and will be published on the IPRP website to promote the understanding of IDMP standards in order to support the implementation.

The main focus topics of MC discussion at the meeting were Reliance and e-labelling. The MC is continuing further discussion on technical aspects of Reliance and on identifying steps for concrete action within IPRP, taking into account roles to be played by other fora such as ICMRA (International Coalition of Medicines Regulatory Authorities). The MC reviewed progress on the development of an article informed by the results of the survey conducted among IPRP parties on e-labelling of pharmaceuticals, when the product information is distributed via electronic means. The article is expected to include an overview of e-labelling status amongst IPRP Regulatory Members as well as considerations on the importance of e-labelling and reflections on its future. Publication is expected in 2022.

Additionally, the IPRP Members shared their experiences on challenges encountered within the course of implementation of ICH Guidelines, in particular on ICH Q12 on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. The MC will keep this topic as an agenda item for the next meetings with the aim of facilitating the implementation of ICH Guidelines.

Finally, the MC noted the results of the survey conducted among IPRP parties on their practices in Environmental Risk Assessment (ERA) and confirmed to discuss more at the next meeting.

The next IPRP MC meeting is planned for the 25^th and 26^th of May 2022 and is foreseen to be held in person in Athens, Greece, situation permitting.

The Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) held its seventh meeting on the 7th and 8th of June 2021. Representatives from 27 IPRP Members and Observers joined the meeting which was organised in a virtual setting in view of the COVID-19 pandemic.

The IPRP welcomed as its newest Member the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA). With this continued expansion in membership, a total of 31 Members and 2 Observers globally are currently cooperating within IPRP. Dr. Peter Bachmann from EC/EMA, Europe and Mr. Diogo Penha Soares from ANVISA, Brazil were elected as IPRP MC Chair and Vice-Chair respectively, to serve for a 1-year term after this meeting.

Focus topics for MC discussion at the meeting included: Reliance, e-labelling and Environmental Risk Assessment (ERA). Following-on from discussions held at the previous meetings on Reliance, the MC noted that a second article on Reliance focusing on the context of a Public Health Emergency is expected for publication by the end of the year. The MC will continue further discussion on technical aspects of Reliance within IPRP and the MC will take into account the recently published WHO Good Reliance Practices. The MC reviewed the preliminary results of a survey conducted among IPRP parties on e-labelling of pharmaceuticals, when the product information is distributed via electronic means, including on use of this concept by the various regulators. The timeframe to answer the survey will be extended and, with the establishment of a drafting group, its results will inform the development of an article on e-labelling expected to be published by 2022. Finally, the MC shared views on Environmental Risk Assessment (ERA), the process by which relevant regulators ensure that the potential influence of pharmaceuticals on the environment are studied and adequate precautions are taken in case specific risks are identified. Considering the relevance of this topic, the MC agreed to continue the discussion in IPRP, exchange experiences and share practices on ERA. A survey will be conducted among IPRP parties on regional practices. More in-depth MC discussion will be considered at the next meeting.

Additionally, the IPRP Members shared their experiences on challenges encountered within the course of implementation of ICH Guidelines, in particular on electronic standards. In view of the importance of ICH Guideline implementation and the need for further discussion, the MC will keep this topic as an agenda item for the next meetings.

Highlights of the meeting also included reports from the 8 IPRP Working Groups (WGs) on Nanomedicines, Cell Therapy, Gene Therapy, Identification of Medicinal Products (IDMP), Quality, Biosimilars, Bioequivalence for Generics, and Pharmacovigilance, presenting their achievements over the past months and their future activities. The MC endorsed the Quality Assessment Report – Full Dossier Template developed by the Quality WG, which provides a common template for the assessment of technical information contained in Common Technical Document (CTD) Module 3 and will assist regulators in the review of applications for marketing authorisation. This template completes the suite of IPRP Quality regulatory tools for the assessment of Quality information related to drug substances and drug products, and will be available shortly on the IPRP website.

The next IPRP MC meeting is planned for the 22nd and 23rd of November 2021 in a virtual format.

The Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) held its sixth meeting on the 19th and 20th of November 2020, with the participation of Representatives from 25 out of the 32 IPRP Members and Observers. For the second time in 2020, the meeting was organised in a virtual format due to the COVID-19 pandemic.

Following the departure of the previous IPRP MC Vice-Chair, the MC elected Dr. Peter Bachmann from EC/EMA, Europe to serve the remainder of the annual term which ends in June 2021.

IPRP Members and Observers shared the latest significant updates on pharmaceutical regulation in their regions, as well as their respective responses to the COVID-19 pandemic. The main focus topic of the meeting was Reliance, the act by which one regulatory authority takes into account and give significant weight to assessments performed by another regulatory authority or other trusted institution in reaching its own decision. The MC agreed to continue advancing discussion on this topic within IPRP in the coming year. The publication of an article on the outcome of a survey developed by the World Health Organization (WHO) and conducted amongst IPRP parties on their experiences of Reliance is expected in the coming months and a second publication is foreseen in 2021 focusing on Reliance in the context of a Public Health Emergency.

The MC reviewed the outcome of the pilot project of the Information-Sharing Working Group (WG) for Generics for the sharing of information on the evaluation of Generic Drug applications and agreed to confirm the closure of the pilot project and the WG. The MC will take into account the experience gained with the pilot to the other IPRP activities and continue moving forward on this topic as part of its broader discussion on Reliance.

Highlights of the meeting also included reports from the IPRP WGs on Nanomedicines, Gene Therapy, Cell Therapy, Identification of Medicinal Products (IDMP), Quality, Biosimilars, Bioequivalence for Generics, and Pharmacovigilance, on their progress and planned activities for 2021. The MC endorsed the final mandate and 2021 work plan of the Pharmacovigilance WG, which will be available shortly on the IPRP website. The Pharmacovigilance WG was established earlier this year to leverage knowledge-sharing and  advance pharmacovigilance collaboration between IPRP members. The MC also noted the progress and milestones reached electronically by WGs, including the finalisation by the Bioequivalence WG for Generics of an article on Biowaivers for dosage forms (oral and injectable products), which has been submitted for publication in a peer review journal.

The next IPRP MC meeting is planned for the 7th and 8th of June 2021 and will be held again in a virtual setting.

The Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) held its fifth meeting on the 28th of May 2020. Representatives from 25 IPRP Members and Observers joined the meeting which was organised in a virtual setting.

The IPRP welcomed as its newest Member the Food and Drug Administration of Indonesia, Badan POM. With this continued expansion in membership, a total of 30 Members and 2 Observers from across the world are currently cooperating within IPRP. Dr. Junko Sato from MHLW/PMDA, Japan and Ms. Hacer Coşkun Çetintaş from TITCK, Turkey were re-elected by consensus as IPRP MC Chair and Vice-Chair respectively, to serve for a further 1-year term.

The meeting included reports from the IPRP Working Groups (WGs) on Nanomedicines, Gene Therapy, Cell Therapy, Identification of Medicinal Product (IDMP), Quality, Biosimilars, Bioequivalence for Generics, and Pharmacovigilance, presenting their achievements since the last meeting and their future activities. The MC endorsed the Guidance for Quality Assessors - Drug Product, developed by the Quality WG, which will provide guidance and assistance to Quality Assessors in the assessment of the technical information contained in the Drug Product Quality Module (Module 3.2.P) and will facilitate the preparation of Quality Assessment Reports. This document will be available shortly on the IPRP website.

IPRP Members and Observers shared the latest updates on pharmaceutical regulation in their regions as well as actions put in place and specific responses to the COVID-19 pandemic. The MC also discussed next steps for the publication of the outcome of the survey developed by the World Health Organization (WHO) and conducted among IPRP parties on their experiences of Reliance, the act by which one regulatory authority takes into account the work performed by another regulatory authority or other trusted institution in reaching its own decision. The publication of an article on this topic is expected before the end of 2020.

The next IPRP MC meeting is planned for the 18th and 19th of November 2020 in Athens, Greece.

The fourth meeting of the International Pharmaceutical Regulators Programme (IPRP) Management Committee (MC) was held on the 20th and 21st of November 2019 in Singapore. Representatives from 25 IPRP Members and Observers from across the world participated in the meeting.

Three new Members were welcomed by the MC: the Center for Pharmaceutical and Enforcement Division of Israel (CPED), the National Pharmaceutical Regulatory Agency of Malaysia (NPRA) and the Saudi Arabia Food and Drug Agency (SFDA). With these newest Members, a total of 29 Members and 2 Observers are now participating in IPRP cooperation activities.

The purpose of the meeting was to review progress of the IPRP Working Groups (WGs), to share information on regional pharmaceutical regulation, and to discuss emerging regulatory topics including in particular Real-World Evidence and Reliance. PIC/S was invited as an ad-hoc Observer participant for this meeting and presented to the MC areas of PIC/S activities in international cooperation relevant to IPRP activities.

The meeting involved a report from the IPRP WGs on activities and achievements since their last report to the MC: Nanomedicines, Biosimilars, Gene Therapy, Cell Therapy, Identification of Medicinal Product (IDMP), Quality for Generics, and Bioequivalence for Generics. The MC reviewed the work conducted by the pilot project of the Information-Sharing WG for Generics for the sharing of information on the evaluation of Generic Drug applications and agreed in view of its completion to propose the closure of the project by the time of the next meeting.

Following-on from discussions held at the previous meeting on real-world evidence and the use of non-conventional data sources for pharmacovigilance purposes, the MC decided to proceed with the establishment of a Pharmacovigilance Working Group with a mandate to leverage knowledge-sharing and opportunities to advance collaboration in the area of pharmacovigilance between IPRP members. This WG will initiate activites after the meeting to develop its work plan and define steps to be taken to enhance the area of pharmacovigilance through collaborations and knowledge-sharing on appropriate methodologies to use and analyze structured and unstructured data, and to complement traditional spontaneous reporting systems through this process, when necessary.

The MC also discussed the outcome of the survey developed by the World Health Organization (WHO) and conducted among IPRP parties on their experiences of Reliance, the act by which one regulatory authority takes into account the work performed by another regulatory authority or other trusted institution in reaching its own decision. The results of the survey were already shared on the IPRP website and will inform the development of an article to be published in 2020. The MC will continue further discussion on this topic at its next meeting.

The next IPRP MC meeting will be held on the 27th and 28th of May 2020 in Vancouver, Canada.