Meetings

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.

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.

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.