Meetings

2020-11-19T12:00:00 - 2020-11-20T12:00:00
/meeting/6th-meeting-virtual
Greece
Athens

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.

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2020-05-28T12:00:00
/meeting/5th-meeting-virtual
Canada
Vancouver

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.

 

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2019-11-20T12:00:00 - 2019-11-21T12:00:00
/meeting/4th-meeting
Singapore

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.

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2019-06-02T12:00:00 - 2019-06-03T12:00:00
/meeting/3rd-meeting
Netherlands
Amsterdam

The third meeting of the International Pharmaceutical Regulators Programme (IPRP) Management Committee (MC) was held on the 2nd and 3rd of June 2019 in Amsterdam, the Netherlands. A total of 22 IPRP Members and Observers from across the world participated in the meeting.

The MC welcomed the National Administration of Drugs, Foods and Medical Devices of Argentina (ANMAT, Argentina) and the Iran National Regulatory Authority (NRA, Iran) as new Members in Amsterdam. With these newest Members, IPRP now has 26 Members and 2 Observers globally. Dr. Junko Sato from MHLW/PMDA, Japan and Ms. Hacer Coşkun Çetintaş from TITCK, Turkey were elected as IPRP MC Chair and Vice-Chair respectively, to serve for a 1-year term.

The purpose of the meeting was to review progress of the IPRP Working Groups (WGs), share information on regional pharmaceutical regulation, and to discuss emerging regulatory topics.

The meeting involved a report from the 8 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, Bioequivalence for Generics and Information-Sharing for Generics. A Frequently Asked Questions document prepared by the IDMP WG was approved and will be published shortly on the IPRP website to support the implementation and promote the understanding of IDMP standards. The MC also endorsed the article developed by the Bioequivalence WG for Generics on Differences and Commonalities amongst Requirements for Additional Strength Biowaivers for Immediate Release Solid Oral Dosage Forms, which will be submitted for publication. The Assessment Report Template on Additional Strength Biowaivers for use by Regulatory Authorities, another deliverable of the Bioequivalence WG for Generics, is already available on the IPRP website.

In the meeting, information was shared, including comparing statutory and regulatory frameworks among regulators, to better identify and understand potential opportunities for 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 MC discussed the outcome of a survey developed by the World Health Organization (WHO) and conducted among IPRP parties on their experiences, challenges, perceived benefits and opportunities of reliance. The MC agreed to continue discussion at its next meeting with a focus on key considerations for reliance.

Another focus topic of the meeting was real-world evidence and the use of non-conventional data sources for pharmacovigilance purposes. Acknowledging the possible benefits that information sharing on this topic could bring to IPRP Regulators, but also its associated technical challenges, the MC agreed as a first line of action to pursue a scoping exercise to explore to what extent this topic could be undertaken within IPRP. Outcomes of the exercise and next steps for this line of work will be further discussed at the next MC meeting.

The next IPRP MC meeting will be held on the 20th and 21st of November 2019 in Singapore.

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2018-11-11T12:00:00 - 2018-11-12T12:00:00
/meeting/2nd-meeting
United States
Charlotte, NC

The second meeting of the International Pharmaceutical Regulators Programme (IPRP) Management Committe (MC) was held on the 11th and 12th of November 2018 in Charlotte, NC, USA with the participation of 19 IPRP Members and Observers.

 

With the MC welcoming in Charlotte its newest Member the Turkish Medicines and Medical Devices Agency (TITCK, Turkey), IPRP now has 23 Members and 2 Observers. The MC reaffirmed the inclusive membership of IPRP, comprised of regulatory authorities and organisations with responsibilities for the regulation of medicinal products for human use or related Regional Harmonisation Initiatives (RHIs) that wish to participate.

 

The meeting in Charlotte marked the end of the first year of the existence of the IPRP, which was launched in January 2018 stemming from the consolidation of the International Generic Drug Regulators Programme (IGDRP) and the International Pharmaceutical Regulators Forum (IPRF). The operationalisation of the IPRP was finalised with the endorsement of its stakeholder engagement plan to be published shortly on the newly launched IPRP website, www.iprp.global.   Other IPRP foundational documents are already published on the website, including the Terms of Reference (ToR), Standard Operating Procedure (SOP), and Strategic Vision. Please visit the new website for the latest achievements of IPRP, including publications of the IPRP Working Groups (WGs) and outcomes of the IPRP MC meetings. The IPRP Secretariat can also be reached via the contact form of the website for any external inquiry.

 

The meeting involved a report from 7 of the 8 IPRP WGs, specifically: Nanomedicines, Biosimilars, Gene Therapy, Cell Therapy, Identification of Medicinal Product (IDMP), Quality for Generics and Bioequivalence for Generics, with several milestones achieved. The MC endorsed the Reflection Paper of the Cell Therapy WG on “General Principles to Address the Nature and Duration of Follow-up for Subjects of Clinical Trials Using Cell Therapy Products” to be published on the IPRP website. Several other publications are also expected in the coming months including: a survey on liposomal product recommendations developed by the Nanomedicines WG, a Frequently Asked Questions (FAQ) by the IDMP WG, a survey on administrative procedures and terminologies for Quality-related post-approval changes by the Quality WG for Generics, and an assessment report template for additional strength biowaivers (immediate release dosage forms) by the Bioequivalence WG for Generics.

 

A main focus topic of the meeting was 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, which has been seen by an increasing number of countries as an important means of improving the efficiency of regulatory operations. In this spirit, the MC has agreed to further use IPRP as a forum for discussion of best practices related to reliance and to assist the WHO in developing further guidance and tools through the experience of IPRP members.

 

The IPRP Members also shared their experiences on challenges encountered within the course of implementation of ICH Guidelines and discussed case studies related in particular to the implementation of ICH Guidelines on electronic standards. Recognising the importance of ICH guideline implementation and the need for further discussion, the MC agreed to keep this topic as a standing agenda item for IPRP meetings going forward.

 

The next IPRP MC meeting will be held on the 2nd and 3rd of June 2019 in Amsterdam, the Netherlands.

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2018-06-02T12:00:00 - 2018-06-03T12:00:00
/meeting/1st-meeting
Japan
Kobe

The inaugural meeting of the International Pharmaceutical Regulators Programme (IPRP) Management Committe (MC) was held on June 2nd and 3rd 2018 in Kobe, Japan with the participation of 20 IPRP Members and Observers.

 

The IPRP was launched in January 2018 stemming from the consolidation of the International Generic Drug Regulators Programme (IGDRP) and the International Pharmaceutical Regulators Forum (IPRF). The purpose of IPRP is to create a venue for regulatory authorities and organizations to share information, discuss issues of common concern, discuss emerging scientific areas of relevance to drug development and regulation, and work towards regulatory convergence. IPRP is comprised of representatives from pharmaceutical regulatory authorities and organisations with responsibilities for the regulation of medicinal products for human use or Regional Harmonisation Initiatives (RHIs) that wish to participate.

 

The first MC meeting focused on the operationalisation of the IPRP through the finalisation and adoption of the IPRP Terms of Reference (ToR). Other foundational elements such as the Strategic Vision, Standard Operating Procedure (SOP) for the MC and Working Groups (WGs), and launch of the new IPRP website will be completed in the coming months. Several IPRP foundational documents will be published on the new website at: www.iprp.global.

 

ANVISA, Brasil and Health Canada, Canada were elected as IPRP MC Chair and Vice-Chair respectively, to serve for a 1-year term.

 

The meeting involved a report from each of the 8 IPRP WGs on: Nanomedicines, Biosimilars, Gene Therapy, Cell Therapy, Identification of Medicinal Product (IDMP), Quality for Generics and Bioequivalence for Generics, as well as Information Sharing for Generics for the sharing of the European Medicines Agency (EMA) review reports.

 

The MC endorsed the Reflection Paper on Expectations for Biodistribution Assessments for Gene Therapy Products that will shortly be published on the IPRP website. Furthermore, two other publications are expected to be submitted to the MC for approval in the coming months: a Reflection Paper developed by the Cell Therapy WG on General Principles to Address the Nature and Duration of Follow-up for Subjects of Clinical Trials Using Cell Therapy Products; and a Survey conducted by the Bioequivalence WG for Generics of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the IPRP.

 

Presentations on focus topics including antimicrobial resistance and the opioids crisis in Canada and USA were provided as well as relevant regulatory updates from IPRP Members and Observers. Discussions took place on potential new topics for ICH. Real World Evidence was identified as a topic of interest which need further experience; and a mapping exercise of the data requirements for novel excipients and how they are defined in each region will be carried out by IPRP.

 

The next IPRP MC meeting will be held on November 11th-12th 2018 in Charlotte, North Carolina, USA.

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