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

In accordance with the Order of the State Institution "Center for the Safety of Pharmaceutical Products" (hereinafter referred to as the Center) dated May 28, 2026 No. 501, from May 31 to June 3, 2026, the delegation of Uzbekistan headed by the Director of the Center A. Temirov paid a business trip to Rio de Janeiro, Federative Republic of Brazil. Among the members of this delegation was F. Usmanova, Chief Specialist of the Department of Development of State Pharmacopoeia F. Usmonova.

Information on cooperation with the visited (state/organizations):

Meetings of the ICH Steering Committee and the MedDRA Steering Committee were held. Alternatively, 12 ICH Expert Working Group (EWG) held face-to-face working sessions.

The meeting was opened by Dr. Gabriela Zenhäusern, Chair of the ICH Assembly, and Mr. Jeffrey Skene (Health Canada, Canada), Deputy Chair. The guests were greeted by Dr. Leandro Safatle, President of the Brazilian National Sanitary Control Agency – ANVISA.

The meeting was attended by representatives of the following regulatory bodies: Health Canada (Canada), Pharmaceutical and Medical Products Agency (PMDA, Japan), SFDA (Saudi Arabia), US Food and Drug Administration (USA), European Commission, Brazilian Health Surveillance Agency (ANVISA, Brazil) and others.

For information: In January 2026, the Secretariat of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) sent an official notification of the establishment of an Expert Working Group (EWG) to develop an Annex to the ICH Q5E Directive.

At the end of the nomination process, Farangiz Usmonova, Chief Specialist of the Department of State Pharmacopoeia Development, was officially included in the ICH Q5E Annex EWG Expert Working Group as an ICH Observer Expert and was invited to the ICH Biannual Meeting.

The main purpose of the meeting of the expert working groups was to reach a final agreement among the experts on the Concept Paper of the ICH Q5E Annex on the issues of comparability after changes in the manufacturing process for advanced therapeutic drugs (ATMP) such as cell, gene and tissue engineering products.

During the meeting, the provisions of the ICH Q5E Core Guidelines were revised and aspects specific to ATMP products were clarified. The scientific and technical challenges that arise in the assessment of comparability for cell therapy, gene therapy, and other ATMP areas were discussed by the experts.

On the first day of the meeting, the current EU and US guidelines on comparability on ATMP products were reviewed. In particular, presentations were made on the European Commission’s 2019 and US FDA’s 2023 documents and views on their practical application were exchanged.

During the second day , national guidelines on ATMP comparability, developed by the regulatory authorities of Japan, China and the Republic of Korea, were presented. The commonalities and differences of these documents were analyzed and issues that need to be harmonized at the level of the ICH were identified. Also, aspects requiring special attention for ATMP products were discussed by the experts. In particular, issues related to the low number of product batches, the variability of biological raw materials, patient-specific products, regional sources of starting materials and the complexity of production were considered.

On the third and fourth days of the meeting, discussions were held with the participation of regulators and industry representatives, the results of which were considered in the preparation of materials to be submitted to the ICH Assembly. The next face-to-face meeting scheduled in Prague was also discussed. At the joint meeting with the ICH Q6(R1) Expert Working Group, the harmonization of specifications and comparability requirements for ATMP products, as well as the preliminary structure of the ICH Q5E Annex document, the formation of the authors' group, and further work plans were agreed.

According to the results of the meeting, the following results were achieved:

1. An agreement was reached among the experts on the Concept Paper for the ICH Q5E Annex document and it was decided to submit the document for consideration by the ICH Management Committee.
2. A common approach was formed on the main scientific and technical aspects that should be taken into account when evaluating the comparability for ATMP products.
3. The regulatory requirements applied in different regions were analyzed and the prospects for their harmonization at the international level were discussed.
4. An agreement was reached on the structure of the ICH Q5E Annex Directive and future development plans.
5. Professional contacts with ICH members and representatives of observer countries were strengthened, and international experience in advanced therapeutic drugs was studied.

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Between Uzbekistan and NAFDAC within the framework of the ICH Assembly
Memorandum of cooperation signed

At the same time, within the framework of the General Meetings of the ICH Assembly and IPRP, the delegation of Uzbekistan headed by the Director of the Center for Safety of Pharmaceutical Products A. Temirov took part in a number of bilateral meetings.

In particular, a formal meeting was held with representatives of the National Drugs and Food Control Agency of Nigeria (NAFDAC). Following the negotiations, a Memorandum of Cooperation was signed between the Centre for Pharmaceutical Product Safety and NAFDAC.

This memorandum provides for the development of cooperation in the field of state registration of pharmaceutical products, inspection activities, laboratory tests, development of the pharmacocontrol system, capacity building of specialists and the introduction of international standards.

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Photo of members of the delegation of Uzbekistan during the meeting with experts of the ICH Assembly and IPRP

During the meeting, NAFDAC’s advanced experience in regulatory activities was closely acquainted. As noted, NAFDAC is one of the leading regulatory bodies in Africa that has achieved Maturity Level 3 (ML3) status according to the WHO Global Benchmarking Tool Assessment System issued by the World Health Organization, and has successfully confirmed this status.

The parties exchanged views on expanding practical cooperation in the areas of regulation of pharmaceutical products, laboratory activities, inspection system, pharmacocontrol and advanced training of specialists.