Uzbekistan Delegation Joins ICH Meetings in Rio de Janeiro and Signs Memorandum with NAFDAC

A delegation from Uzbekistan led by A. Temirov, Director of the Center for Safety of Pharmaceutical Products, took part in the meetings of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), held on 31 May – 3 June 2026 in Rio de Janeiro, Federative Republic of Brazil. The visit was carried out under the Center's Order No. 501 of 28 May 2026, and the delegation included F. Usmonova, Chief Specialist of the State Pharmacopoeia Development Department.

The programme featured meetings of the ICH Management Committee and the MedDRA Steering Committee, while 12 ICH Expert Working Groups (EWG) held face-to-face working sessions. The proceedings were opened by the Chair of the ICH Assembly, Dr. Gabriela Zenhäusern (Swissmedic, Switzerland), and Vice-Chair Mr. Jeffrey Skene (Health Canada, Canada); participants were welcomed by ANVISA President Dr. Leandro Safatle. Representatives of regulatory authorities took part, including Health Canada, PMDA (Japan), SFDA (Saudi Arabia), the U.S. Food and Drug Administration (FDA), the European Commission and ANVISA (Brazil).

A key outcome of the trip was the formal appointment of Farangiz Usmonova, Chief Specialist of the State Pharmacopoeia Development Department, as an Observer Expert (ICH Observer Expert) on the Expert Working Group developing the Annex to the ICH Q5E guideline. Established in January 2026, the group addresses post-manufacturing-change comparability for advanced therapy medicinal products (ATMP) — cell, gene and tissue-engineering products. At the close of the meeting, the experts reached agreement on the Concept Paper and decided to submit it for review by the ICH Management Committee.

Memorandum of cooperation signed with NAFDAC

Within the ICH Assembly and the general IPRP meetings, the delegation led by A. Temirov took part in a series of bilateral meetings. In particular, following official negotiations with Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC), a memorandum of cooperation was signed between the Center and NAFDAC. The document provides for cooperation in the state registration of pharmaceutical products, inspection activities, laboratory testing, development of the pharmacovigilance system, capacity-building for specialists, and the implementation of international standards.

NAFDAC is one of Africa's leading regulatory authorities, holding Maturity Level 3 (ML3) status under the World Health Organization (WHO) Global Benchmarking Tool. Participation in the Rio de Janeiro events served to deepen the integration of Uzbekistan's State Pharmacopoeia into international pharmaceutical harmonisation and to expand practical cooperation with leading regulators.