Accelerate Registration of Medical Products

Progetto concluso

Efforts in research and development of medical products for diseases disproportionately affecting people in low and lower middle-income countries have been multiplied. Yet, after successful development of a medical product 4-7 years elapse before it is registered in these countries. Through the World Health Organisation and the Swiss Agency for Therapeutic Products, SDC aims to strengthen capacities of African medicines regulatory authorities and increase the efficiency of regional and global medicines regulatory procedures.

Paese/Regione Tema Periodo Budget
Africa
Sanità
Rafforzamento dei sistemi sanitari
01.12.2015 - 31.12.2018
CHF 1'970'000
Contesto

Access to safe and efficacious quality medical products is a complex issue. A major factor delaying access that is often overlooked is the lengthy evaluation and registration procedure that may last up to 7 years in some low and lower-middle income countries. This “drug-lag” causes unnecessary ill-health and death.

Obiettivi

Foster access to efficacious and safe quality medical products for people in low and middle-income countries, especially in sub-Saharan Africa, through medicines regulatory systems strengthening at the global, regional and country level.

Gruppi target

Primary beneficiaries are people in East African and other low and lower middle-income countries who are in need of medical products for which marketing authorisation at the level of Swissmedic and registration in their home countries will be sought. Secondary beneficiaries are collaborators of the six national medicines regulatory authorities in the East African Community who benefit from capacity building measures provided by WHO and Swissmedic in the countries. Organisations that seek marketing authorisation for their global health products are also beneficiaries.

Effetti a medio termine

Evaluation and registration of medical products for diseases disproportionately affecting people in low and lower middle-income countries is accelerated at the global and national level.

Risultati

Risultati principali attesi:  

Output 1: The technical and managerial capacities of national medicines regulatory authorities (NMRAs) in Member States in the East African Community (EAC) are strengthened.

Output 2: Regional harmonization: Medical product dossiers submitted to the EAC NMRAs are jointly assessed in accordance with harmonised guidelines and established procedures.

Global level:

Output 3: Swissmedic marketing authorisation procedure for medical products against diseases disproportionately affecting people in low and lower middle-income countries is used by relevant applicants (e.g. Product Development Partnerships).

Output 4: Swissmedic scientific advice procedure during developmental phase of a medical product for diseases disproportionately affecting people in low and lower middle-income countries is used by NMRAs and the WHO pre-qualification programme.


Risultati fasi precedenti:  

  • Around 80 guidelines were developed and endorsed at national level by the respective EAC Members States.
  • Five generic (non-patented) products, previously approved through the WHO prequalification programme, were registered within one to three months in all five EAC Member States thanks to joint dossier assessments.


Direzione/Ufficio responsabile DSC
Credito Cooperazione allo sviluppo
Partner del progetto Partner contrattuale
Organizzazione delle Nazioni Unite (ONU)
  • Organizzazione mondiale della sanità


Altri partner

Swiss Agency for Therapeutic Products (Swissmedic), Bill and Melinda Gates Foundation, East African Community, Agency for New Partnership for Africa’s Development

Coordinamento con altri progetti e attori

Medicines for Malaria Venture (MMV), Drugs for Neglected Diseases Initiative (DNDi), Swiss Tropical and Public Health Institute (Swiss TPH)

Budget Fase in corso Budget Svizzera CHF   1'970'000 Budget svizzero attualmente già speso CHF   1'970'000
Fasi del progetto Fase 2 01.01.2019 - 31.12.2021   (Fase in corso)

Fase 1 01.12.2015 - 31.12.2018   (Completed)