06/02/2026
On 04 February 2026, the Medicines Control Agency (MCA) convened a high-level Stakeholder Engagement Forum
MCA organised a forum with Stakeholders which served as a platform to align the Agency’s regulatory goals with the operations of Stakeholders, including Importers and Exporters, Distributors/Suppliers of Medicines and Related Products including Cosmetics and Medical Devices.
The Acting Executive Director, Mr. Essa Marenah, delivered the opening remarks, outlining MCA’s roadmap which also included the maintenance of its’ ISO 9001:2015 Certification since 2019 as inclined with international standards, thus as required by ISO MCA operations using the Quality Management System which ensures its Stakeholders and Public safety are of high importance to the Agency. In addition, the Agency also started its journey towards attaining WHO Maturity Level 3 (ML3) making it committed to "SMART Regulation," which balances rigorous oversight with operational efficiency.
On Human Capital Development, he informed that MCA requires a workforce equipped with advanced knowledge, skills and abilities to enable a meaningful service delivery to stakeholders.
Mr. Marenah emphasized that both under-regulation and over-regulation are detrimental to the healthcare ecosystem and will not be compromised, ensuring that safety, efficacy, and quality remain the priority of MCA.
Ms. Fatou Faal, Legal & Enforcement Officer, explained to Stakeholders about the new Amendment Act, 2025 which add a new dimension to MCA’s work relating to Marketing Authorisation and importation and it relates Section 26 , amended in 2025 by the National Assembly and accented by H.E The President on 20 January 2026 and Sub-section 4 and 5 which authorised the importation of Medicines and Related Product that are produced, manufactured or sourced and approved for sale and distribution from a Country with a Stringent Regulatory Authority (SRA).
Ms. Fatou Njie, Director Clinical Trial & Pharmacovigilance discussed the importance of ADRs/AEFIs reporting citing various outreach programs carried by MCA across the country highlighting the importance of reporting which will feed the National Pharmacovigilance Centre at MCA.
She encourages partners to be reporting of ADRs/AEFIs to MCA immediately within certain time frame, which will enhance decision-making accordingly.
Ms. Mariama Simah, Director Evaluation & Registration outlined the processes for product assessment and registration with emphasis on the requirements of listing, stating the guidelines for all the process are on MCA’s website and she encourages Stakeholders to read them for ease of collaboration with the Agency.
Mr. Tijan Jallow, Director of Operation, highlighted the importance of stakeholders supporting the agency by complying with the requirements for imports, export and licensing, which will minimize enforcement actions. He also reminded Stakeholder the importance of the letter shared with them which highlights the critical challenges the Agency faced in terms of compliance on various aspects including change of manufacturers licence number, unique flavour on the product and MCA registration number.
He stated MCA is still faced by challenges relating to expiry products disposal where some people will include items not approved for disposal and he encouraged Stakeholders to communicate with the Agency on time and to also do away from violating the Act to avoid regulatory sanctions.
There was a discussion which allowed Stakeholders to voice concerns, seek clarification on operational bottlenecks and make suggestions to MCA.
MCA Team provided clear, concise responses to all questions accordingly.
The Stakeholder Engagement Forum successfully bridged the communication gap between the Regulator and Stakeholders by fostering a spirit of "SMART Regulation" and partnership towards public safety.
