In May 2014, Ghana's Food and Drugs Authority (FDA) was designated by the New Partnership for African Development (NEPAD) and the African Regulatory Harmonization (AMRH) as a Regional Centre of Regulatory Excellence (RCORE) in Clinical Trials and Drug Registration. This designation was assigned to FDA Ghana in recognition of the institution’s proven capacity and capability in training and delivering as a regulator of clinical trials.
As an RCORE, the FDA seeks to build regulatory capacity in Africa to facilitate quality review of clinical trials and harmonize existing clinical trial processes in the sub region in line with globally accepted standards. This is to ensure that African citizens have access to quality, safe and efficacious medication, medical devices and health products.
Following the FDA’s designation as an RCORE, the Clinical Trials Training Manual for Capacity Building in Regional Centres of Regulatory Excellence (RCOREs) and other training institutions was developed in 2016 by the FDA in collaboration with the University of Ghana School of Public Health. This manual can be found on the website of NEPAD.
Since 2017, FDA Ghana has been organizing an annual RCORE clinical trials fellowship that has trained a total of fifty-four (54) clinical trials regulatory experts from ten (10) African countries.
The RCORE Fellowship training is an intensive 4 week learning journey with theoretical and practical training modules. The specific objectives are the training are as follows:
Increasing regulatory workforce to facilitate review of clinical trials conducted in Africa.
Harmonising and improving existing clinical trial processes in Africa in line with globally accepted standards (WHO an ICH guidelines) while taking into consideration local conditions peculiar to each African country.
Providing a platform for regulators and researchers to continually share ideas, knowledge and experiences over the years.
Helping African regulators to enhance and effectively apply the existing regulatory tools in the regulator’s toolkit.
Building capacity and enhancing skills of regulators in the area of effective clinical trial regulation through hands-on training and exchange programmes to help improve their output.
So far, the RCORE training has been well appreciated by the participants with training objectives and expected learning outcomes being achieved. Participants have reported increased knowledge of drug development processes and the impact of research on the safety, quality and efficacy of medicines. Trainees were keen on using the knowledge and skills acquired in their respective fields of work and improving clinical trial regulation in their home countries and the sub-region. It can therefore be deduced that the training was effective in accomplishing its core goal of building the capacity of the participants to strengthen and harmonize the clinical trial regulatory systems in Africa.
The RCORE training therefore has the potential to enhance the conduct of clinical trials in Africa, thus the training of RCORE trainers as part of the BERC-Africa project would serve as a significant step towards the achievement of this aim. The BERC-Africa project also offers the opportunity for the FDA Ghana to extend the scope of this RCORE training to serve Francophone countries for the first time. Under this funding, provision has been made to enable the translation and delivery of the RCORE training and training material in French.