On 25 August 2023, the South African Health Products Regulatory Authority (SAHPRA) was appointed as the Regional Centre of Regulatory Excellence (RCORE) for Vaccines Regulatory Oversight for 4 years. SAHPRA will be responsible on:
Overarching regulatory system
Marketing authorization and registration
Vigilance
Market surveillance and control
Licensing of premises
Regulatory inspections
Laboratory access and testing
Clinical trials
Lot release
The African Union Development Agency, New Partnership for Africa’s Development (AUDA-NEPAD) builds up the RCOREs to strengthen the regulatory capacity development in Africa and to support the system by utilizing the potential of better-resourced regulators . 11 RCOREs have been appointed through the African Medicines Regulatory Harmonization (AMRH) program for 8 different regulatory functions, including:
Pharmacovigilance
Training in core regulatory functions
Quality assurance and quality of medicines
Medicine registration and evaluation, quality assurance, quality control, and clinical trials oversight
Manufacturers’ licensing, import, export, distribution, inspection, and surveillance of manufacturers. importers, wholesalers, and dispensers of medicines
Medicine evaluation and registration
Access to essential medications is significantly hampered by the medicine regulatory capacity limitation, which also places a cap on the effort of regulatory harmonization. Consequently, RCOREs are taking on the responsibility of strengthening the regulatory workforce through regulatory functions training and exchange programs among National Medicines Regulatory Authorities for skills enhancement.