Swissmedic procedure for scientific advice and Marketing Authorisation for Global Health Products (MAGHP)

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^[1](LMICs), 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) are invited to participate actively 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 the marketing authorisation by NRAs will be significantly reduced, making essential medicines available for patients faster.

Relevant Administrative Ordinances

ZL000_00_014e_WL Guidance document Time limits for authorization applications HMV4 (PDF, 386 kB, 01.01.2023)

ZL101_00_005e_WL Guidance document Authorisation of human medicinal product with new active substance HMV4 (PDF, 251 kB, 15.09.2021)

ZL101_00_012e_WL Guidance document Authorisation biosimilar HMV4 (PDF, 279 kB, 01.03.2021)

ZL101_00_007e_WL Guidance document Authorisation of human medicinal product with known active pharmaceutical substance HMV4 (PDF, 395 kB, 01.06.2022)

_{[1] As defined by the World Bank

(https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups)}