Ghana would from Monday November 27 to Tuesday November 28, host the 3rd Biennial Scientific Conference on Medical Products Regulation in Africa that would allow participants to deliberate on the proper regulations of medical products in Africa.
The conference would be organised by international stakeholders with support from the West African Health Organisation, (WAHO), NEPAD, the Government of Ghana, FAPMA, and the IFPMA.
It would bring together, key stakeholders including regulators, policymakers, academia, the scientific community, private sector and civil society from across Africa to deliberate on the theme for the conference: “Sustaining the Momentum for Regulatory Harmonisation in Africa”.
Participants are expected to discuss and contribute towards the future of regulation and harmonisation in Africa, which affects both industrial and regulatory aspects, as well as the aspirations of civil society, and its wish to benefit from best practice, and best medicine.
A document made available to the GNA by NEPAD and Penplusbytes on Friday said significant strides had been made over the years to enhance and modernize the regulation of pharmaceutical manufacturing and product quality across the world.
However, the drug registration system in Africa remained complex and varied, and with each country invoking separate audit and assessment processes, it almost guarantees that Africans would be the last to benefit from new drugs launched onto the international market and that the harmonisation of the processes for medicine registration was long overdue.
The document indicated that under the African Medicines Regulatory Harmonization (AMRH) initiative, there were some ongoing pilot projects aimed at improving national registration processes and these would go a long way towards meeting the goal of regulatory harmonization and convergence.
It revealed that many countries deal with regulatory issues independently, which meant that the manufacturers had to make a formal registration in every country, and each country’s regulatory agency would assess whether the drug was right for its market.
“These assessments may include visits to the manufacturing country to determine whether medicines are produced using good manufacturing systems and processes. What is needed is a single agency, which can do all this work once (rather than 50+ times) and then allow applicants and individual countries to benefit from it”.
It said with the many neglected tropical diseases, mechanisms needed to be found to encourage greater research and ethical clinical testing to find solutions for these diseases.
The conference would therefore, provide a platform for stakeholders to brainstorm on the role of ethical and regulatory approval of clinical trials of new medicines.
Delegates are expected from across the continent, as well as from industry and international regulatory agencies.
The organizing Committee for the conference comprised of the NEPAD Agency, the African Union Commission (AUC), the World Health Organization (WHO), and the National Medicines Regulatory Authorities (NMRAs).
The rest are the Regional Economic Communities (RECs) and Regional Health Organizations (RHOs), the International Federation for Pharmaceutical Manufacturers (IFPMA) and Associations and Federation of African Pharmaceutical Manufacturers Associations (FAPMA).