Iran, Argentina Join International Drug Regulators Group
Regulators from Iran and Argentina have joined the International Pharmaceutical Regulators Programme (IPRP) as members, the IPRP announced following its third management committee meeting in Amsterdam earlier this month.Less than a year after its first management committee meeting, IPRP’s membership has expanded to 26 members and two observers with the addition of Iran’s National Regulatory Authority (NRA) and Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT).
During the meeting the group voted to elect Junko Sato of Japan’s Ministry of Health, Labour and Welfare and Hacer Coşkun Çetintaş from the Turkish Medicines and Medical Devices Agency (TİTCK) to one-year terms as chair and vice-chair of the management committee.
The IRPR’s eight working groups presented updates on their activities since its second management committee meeting in Charlotte, North Carolina last November, including reports on nanomedicines; biosimilars; cell and gene therapies; bioequivalence and information-sharing for generics; and identification of medicinal products (IDMP).
The management committee also approved a frequently asked questions (FAQ) on IDMP which was recently published to the IPRP website, as well as an article from the bioequivalence working group titled, Differences and Commonalities amongst Requirements for Additional Strength Biowaivers for Immediate Release Solid Oral Dosage Forms, which IRPR says will be submitted for publication.
The committee also discussed the different statutory and regulatory frameworks among its members to look for opportunities for mutual reliance and agreed to focus on reliance across regulatory authorities at its next meeting in Singapore in November.
Additionally, the committee discussed applications for real-world evidence and “non-conventional data sources” for pharmacovigilance as well as the benefits and technical challenges to information sharing across regulators. The committee agreed to conduct a scoping exercise to determine how real-world evidence information sharing could be undertaken by the IPRP.
IPRP