A critical AU Model Law aimed at harmonizing medical products regulatory systems in Africa was endorsed by African Heads of State and Government at the January 2016 AU Summit in Addis Ababa, Ethiopia. The AU Model Law will contribute towards accelerate the regulation of safe, quality and affordable medical products and technologies in Ghana.
The West Africa Medicines Regulatory Harmonization (MRH) programme was launched in 2015 in Accra, Ghana. Ghana participated in the establishment of the joint MRH Project Steering Committee and formation of 7 Technical Working Groups (TWG’s). The TWG’s are tasked with developing technical guidelines of the MRH programme. In addition, a joint framework of collaboration between WAHO and WAEMU has been agreed upon.
Ghana has two designated RCORES specializing in Pharmacovigilance and medicines registration and evaluation and clinical trials oversight: University of Ghana Medical School – WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance; and Foods and Drugs Authority (FDA) of Ghana respectively. RCOREs are institutions with specific academic and technical regulatory science expertise and training capabilities capable of producing regulatory workforce in Africa.
Key Results
The West Africa Medicines Regulatory Harmonisation (MRH) programme was launched in 2015 in Accra, Ghana. Ghana participated in the establishment of the joint MRH Project Steering Committee and formation of seven Technical Working Groups (TWG’s). The TWG’s are tasked with developing technical guidelines of the MRH programme. In addition, a joint framework for collaboration between the West African Health Organisation (WAHO) and West African Economic and Monetary Union (WAEMU) has been agreed upon
Ghana has two designated RCORES specializing in Pharmacovigilance and medicines registration and evaluation and clinical trials oversight: University of Ghana Medical School – WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance; and Foods and Drugs Authority (FDA) of Ghana respectively. RCOREs are institutions with specific academic and technical regulatory science expertise and training capabilities capable of producing regulatory workforce in Africa
A critical AU Model Law aimed at harmonising medical products regulatory systems in Africa was endorsed by African Heads of State and Government at the January 2016 AU Summit in Addis Ababa, Ethiopia. The AU Model Law will contribute towards accelerate the regulation of safe, quality and affordable medical products and technologies in Burundi
Clinical trials were conducted by the FDA in 2017
A Clinical Trials Training Manual was published and widely circulated. This was in collaboration with University of Ghana School of Public Health, Ghana FDA, International Aids Vaccines Initiative (IAVI) and the NEPAD Agency. The published Clinical Trials Training Manual was piloted at the University of Ghana in June 2017. The Clinical Trials Training Manual includes modules ranging from Trial Management, Trial Implementation, Quality Assurance in Clinical Trials and End of Study Process. Other modules include Post Marketing Approval and Safety Monitoring, Risk Management and Signal Detection, as well as Clinical Trial Protocol Development and Developing Clinical Trial Applications, among others
