EAC Partner States' Experts Review Applications for Medical Products to Ensure their Quality and Efficacy

07 Feb 2022

East African Community Headquarters, Arusha, Tanzania, 7th February, 2022: Experts from EAC Partner States’ National Medicines Regulatory Authorities have convened in Entebbe, Uganda to conduct a joint scientific review to assess the safety, efficacy and quality of 20 medical products.

The five-day joint assessment aims at streamlining medicines evaluation and registration procedures in an effort to enhance access to good quality, safe and efficacious medicines in the region.

Dr. Felistas Chepwogen, the Head Regional Coordination, Pharmacy and Poisons Boards, Republic of Kenya, said that most of the EAC Partner States have challenges in assuring the safety, efficacy and quality of medicines circulating in their markets due to various factors including limited human and infrastructural capacity to regulate, varying standards of regulations, and long procedures to introduce new medicines in the market.

“As a region, we are now able to facilitate timely assessments and approvals of medicinal product dossiers by the regulatory authorities for pre-marketing evaluation, marketing authorization/registration and post-marketing review through such regional joint assessment sessions,” said Dr. Chepwogen.

Dr. Juliet Okecho, the Director of Product Assessment and Registration, on behalf of the Secretary, National Drug Authority, Republic of Uganda, hailed efforts by the EAC Secretariat in coordinating the National Medicines Regulatory Authorities for a noble cause against substandard and falsified medicines in the region through enhancing strategic partnerships within the region.

“I commend the collaborative efforts by EAC aimed at harnessing resources and supporting harmonization efforts on Medicine Evaluation and Registration (MER) within the region given the limited capacities of individual member states,” said Dr. Okecho.

The 22nd EAC Joint Assessment Session of Medical Product Dossiers meeting, which is scheduled from 7th to 11th February, 2022, is expected to review twenty 20 applications of medical products based on harmonized technical common documents to facilitate uniformity in medicines evaluation and avoid duplication of efforts between Medicines Regulatory Authorities in the EAC region.

Speaking on behalf of the EAC Secretary General, Ms. Jane Mashingia, the EAC Regional Technical Advisor, EAC-MRH Programme, hailed the experts for their dedication and commitment since the commencement of the EAC Joint Assessment Procedure in July 2015, noting that to date, 169 applications have been submitted by pharmaceutical manufacturers for joint scientific review.

“Out of the 169 application, 79 medical products have been recommended for marketing authorization, 20 new applications are currently under review, while the remaining are at different stages of review including more than 50 applications awaiting applicant responses to queries raised by regulators,” said Ms. Mashingia.

Ms. Mashingia said that strong governance of the pharmaceutical sector and effective, independent, and transparent regulatory systems would provide the foundation for greater access to medicines.

“Every country is obligated to regulate the pharmaceutical products sold within its borders. This includes, among others, pre-approval scientific assessment of essential medicines (registration) so that citizens can access these medicines and be assured that they meet acceptable standards of safety, quality, and efficacy,” said Ms. Mashingia.

The EAC Joint Assessment Procedure for medical products is based on technical guidelines compiled by a Technical Working Group (TWG) on Medicines Evaluation and Registration (MER) of the EAC Medicine Regulatory Harmonization (EAC MRH) Programme.

The group relied on their experience and knowledge on medicines registration requirements of their individual Countries, World Health Organization (WHO), and the International Conference on Harmonization of Technical Requirements for Registration of Medicines for Human Use (ICH), as well as other available literature.

Notes to Editors:

Harmonization of medicines registration is an explicit policy priority under Chapter 21 (Article 118) of the EAC Treaty and vital in enabling the free movement of goods in line with the EAC Common Market Protocol. The East African Community (EAC) Medicines Regulatory Harmonization is a regional programme and is part of the continental initiative, the “African Medicine Regulatory Harmonization (AMRH)” whose aim is to address the concerns of lack of standardized approaches in regulation of medicine, vaccines and medical devices.