In line with the project’s overall objective to improve and accelerate access to health interventions and therapeutic products in low- and middle-income countries (LMIC), Project Component II aims to make the Swissmedic authorisation procedure and the procedure for providing scientific advice accessible to representatives of regulatory authorities in these countries as well as to the WHO. Although other countries or regions may be involved, the initial focus in the pilot phase is on the East African Community (EAC) and on medicinal products for those diseases that affect the region disproportionately. The procedure builds on the existing procedure for Marketing Authorisation for Medicinal Products not intended for the Swiss Market (export registration). The National Regulatory Authorities (NRAs) have the option to participate actively in the assessment or to observe the procedure, with the aim of building their own capacities and to establish confidence in the process. Moreover, it is expected that the timelines for the WHO-PQ listing (Link) and marketing authorisation by NRAs will be significantly reduced, making essential medicines available for patients faster.
Draft Procedure for Scientific advice meetings during the developmental phase of a medicinal product intended for submission under the Swissmedic Marketing Authorisation for Global Health Products (MAGHP)