Open Call in ERA Initiative on Strengthening regulatory capacity for supporting conduct of clinical trials - EDCTP3 Joint Undertaking

The ERA initiative launched a call on supporting global health focusing on the topic of Strengthening regulatory capacity for supporting conduct of clinical trials with deadline for full proposals on 30 August 2022, 17:00 CEST.

Deadline:

30 August 2022 at 17:00 CEST: deadline for full proposals

Weblink (URL):

Link

Short Call Abstract:

The aim of this call is to support activities that contribute to one or several expected outcomes:

  • Enhanced regulatory capacity to conduct clinical trials in sub-Saharan Africa countries, complementing the work of the African Vaccine Regulatory Forum (AVAREF);
  • Increased common regulatory mechanisms across sub-Saharan Africa countries, including better alignment with regional standards and overarching continental mechanisms such as the African Medicines Agency;
  • Better equipped health systems to integrate new or improved health technologies;
  • Improved efficiency regarding the process of market authorisation of new or improved health technologies;
  • Improved efficiency of the National Regulatory Agencies (NRAs) concerning clinical trials oversight;
  • Lessons and principles that will help continental or regional Regulatory Agencies in sub-Saharan Africa to better define their function, frameworks and capabilities;
  • Stronger African ownership and leadership of clinical research in sub-Saharan Africa countries;
  • Better collaboration between NRAs and national and institutional research ethics committees, research integrity offices and data access committees;
  • Accelerated maturity towards level 4 of the Regulatory Agencies in sub-Saharan Africa.

SSH aspects (keywords/disciplines):

Disciplines may include (but are not limited to) law, political sciences, economics, etc.

Specific participation requirements (optional):

According to the Article 110 of the Council Regulation (EU) 2021/2085, funding from the Global Health EDCTP3 Joint Undertaking is restricted to legal entities established in Member States or associated countries or in the constituent states of the EDCTP Association.

Constituent states of the EDCTP Association that are not Member States or associated countries are: Burkina Faso, Cameroon, Congo, Cote d/Ivoire, Ethiopia, Gabon, the Gambia, Ghana, Kenya, Mali, Mozambique, Niger, Nigeria, Senegal, South Africa, Tanzania, Uganda, United Kingdom, Zambia;

Countries

The Member States of the European Union, including their outermost regions;

The Oversees Countries and Territories (OCTs) linked to Member States;

Eligible non-EU countries:

  • Countries associated to Horizon Europe
  • Countries that are members of the EDCTP Association