WHO Support to Global Health Products Procedures such as EU-Medicines for all (EU-M4all) and Swissmedic Marketing Authorization for Global Heath Products (MAGHP)
Regulation and Prequalification
Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.
Global Health Products Procedures
International collaboration in the evaluation of medicines to be used globally and WHO Role
The Global Health Products Procedures such as EU-Medicines for all (EU-M4all) or Swissmedic Marketing Authorization for Global Health products are based on the principle of involving WHO experts and National Regulatory Authorities in the evaluation conducted by EMA or Swissmedic. The aim is to build trust and capacity, to increase collaboration and to facilitate access to quality-assured medicines globally.
European Union Medicines for All procedures (previously referred as Article 58)
The European Medicines Agency (EMA), in cooperation with the World Health Organization (WHO), can provide scientific opinions on high priority human medicines, including vaccines, that are intended for markets outside of the European Union (EU). WHO is involved in the eligibility procedure to the EU-M4all, as EMA consults the WHO team before confirming eligibility to the procedure. The role of WHO is also to facilitate participation of WHO experts and target National Regulatory Authorities in the scientific evaluation conducted by EMA (e.g. for scientific advice and initial authorization). In order to start an EU-M4all procedure, please contact the EMA.
Swissmedic Marketing Authorization for Global Health Products
The procedure builds on the normal procedure for marketing authorization for medicinal products conducted by Swissmedic, involving WHO experts. National Regulatory Authorities (NRAs) are also 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 authorization by NRAs will be significantly reduced, making essential medicines available for patients faster. The role of WHO is to facilitates participation of WHO experts and target National Regulatory Authorities in the scientific evaluation conducted by Swissmedic (e.g. for scientific advice and initial authorization). In order to start a MAGHP procedure, please contact the Swissmedic.
Contact us:
/regulation-and-prequalification-(rpq)/regulation-and-safety-(reg)/global-health-products--ok.jpg?sfvrsn=95dae5fc_3 "Global-Health-Products--ok")