EDCTP aims at improving the quality of clinical trials, integrity of data collected, safety of the participants involved and ultimately registration of products in countries that need them most. Together with WHO, EDCTP is funding a series of activities and projects that aim to strengthen the national regulatory framework in Africa.

Regulatory pathways activities:

• Joint review of clinical trial applications for drugs and vaccines
• African Vaccine Regulatory Forum (AVAREF)
• Link between regulatory submissions of clinical trial applications and entries in clinical trials registries: Establishment of a strategy to link regulation and registration of clinical trials
• Training activities aimed at harmonisation of regulatory requirements for the clinical trials of vaccines and medicines
• Interactive activities on roles and responsibilities of Ethics Committees and National Regulatory Authorities for the regulatory oversight of clinical trials.

Global Training Network Activities:     

• Training course on authorisation of clinical trial applications
• Training course on Good Clinical Practice inspections
• Training skills course for trainers of above mentioned courses
• Monitoring of regulatory functions and progress in Africa.

• WHO programme to strengthen regulatory systems in African countries with focus on clinical trial application and inspection of clinical trials
  World Health Organization (WHO)