For the first time Swissmedic, the Swiss Agency for Therapeutic Products, has authorised a new medicinal product (known as an “API with innovation”) under the MAGHP procedure. Experts from the National Regulatory Authorities (NRAs) of Uganda, Kenya, Tanzania (mainland and Zanzibar), South Sudan, Nigeria, Democratic Republic of Congo and Ethiopia have participated in the procedure.
Based on this form of cooperation between regulatory authorities, Swissmedic has authorised Carbetocin Ferring, injectable solution, for the prevention of uterine haemorrhage due to postpartum uterine atony. The decision represents a Swissmedic marketing authorisation according to the regulatory requirements in Switzerland. In the next phase of the procedure, the applicant will submit the dossier to the participating NRAs, which are expected to approve it in their respective jurisdictions within 90 calendar days from receipt.
The MAGHP procedure aims to make the Swissmedic authorisation procedure and the scientific advice procedure accessible to representatives of regulatory authorities in low- and middle-income countries as well as to the World Health Organization (WHO). Although other countries or regions may be involved, the initial focus in the pilot phase is on Sub-Saharan Africa and on medicinal products for those diseases that affect the region disproportionately.
The procedure builds on the existing procedure for marketing authorisation. The NRAs have the possibility to participate in the assessment with the aim of building their own capacities and establishing confidence in the process. Moreover, it is expected that the timelines for marketing authorisation by NRAs will be significantly reduced, accelerating access to essential medicines for patients.