South Africa: SAHPRA Appointed as RCORE for Vaccines Regulatory Oversight

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.

Source: South African Health Products Regulatory Authority (SAHPRA)