- Seventy nine out of 169 medical products now recommended for marketing authorization
- Long procedures to introduce new products on market still a concern
- Every country told to strengthen border controls on medicines
East African countries are yet to guarantee the safety, efficacy and quality of medicines circulating in their markets as their capacity to regulate the products remains limited, a meeting has heard.
Regional experts are meeting in Kampala, Uganda to conduct a scientific assessment of 20 applications of medical products, a move that comes in the wake of persistent reports about the presence of substandard medicines.
National Medicines Regulatory Authorities in the East African Community are carrying out a five-day joint assessment that is expected to streamline medicines evaluation and registration procedures in an effort to enhance access to good quality, safe and efficacious medicines in the region.
“[Regulation is affected] by various factors including limited human and infrastructural capacity to regulate, varying standards of regulations, and long procedures to introduce new medicines in the market,’’ said Dr Felistas Chepwogen, the Head Regional Coordination, Pharmacy and Poisons Boards of Kenya.
At the moment, according to Chepwogen, the region is currently 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.
Uganda’s Director of Product Assessment and Registration Dr Juliet Okecho, said the noble cause against substandard and falsified medicines in the region through enhancing strategic partnerships with in the region is commendable.
To date 169 applications have been submitted by pharmaceutical manufacturers for joint scientific review, as per the Assessment Procedure in July.
The 22nd EAC Joint Assessment Session of Medical Product Dossiers meeting, which is scheduled from 7th to 11th February, 2022, is expected to review applications of medical products from the region.
The evaluation, according a statement released by the EAC, is based on harmonized technical common documents that would facilitate uniformity in medicines evaluation and avoid duplication of efforts between Medicines Regulatory Authorities.
Speaking on behalf of the EAC Secretary General, Ms. Jane Mashingia, the EAC Regional Technical Advisor, EAC-MRH Programme, said out of the 169 applications submitted, 79 medical products have been recommended for marketing authorization, 20 new applications are currently under review.
“…the remaining are at different stages of review including more than 50 applications awaiting applicant responses to queries raised by regulators,” said Ms. Mashingia.
“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 Mashingia.