25 Aug SAHPRA Earns a Regulatory Accolade of Note
Pretoria, 25 August 2023 –The South African Health Products Regulatory Authority (SAHPRA) has been designated as a Regional Centre of Regulatory Excellence (RCORE) for Vaccines Regulatory Oversight for a period of four (4) years in the following functions:
- Overarching Regulatory Systems
- Marketing Authorisation and Registration
- Vigilance
- Market Surveillance and Control
- Licensing of Premises
- Regulatory Inspections
- Laboratory Access and Testing
- Clinical Trials
- Lot Release
The rationale behind the African Union Development Agency, New Partnership for Africa’s Development (AUDA-NEPAD) designating RCOREs is to support continent-wide regulatory systems strengthening through leveraging capacity in better resourced regulators. The reality of medicine regulatory capacity limitation on the continent continues to hinder access to essential medicines as well as limit progress in regulatory harmonisation efforts. The intention is to address this regulatory gap and ensure the acceleration and strengthening of regional medicines regulatory harmonisation initiatives. RCOREs are required to support regulatory workforce strengthening through training in regulatory functions and enhance skills through hands-on training and exchange programmes amongst National Medicines Regulatory Authorities.
About RCOREs
The Regional Centres of Regulatory Excellence (RCOREs) is an initiative of the AUDA-NEPAD. As part of its mandate to strengthen regulatory capacity development in Africa, AUDA-NEPAD through its AMRH programme has designated 11 RCOREs in eight different regulatory functions which include:
- Pharmacovigilance
- Training in core regulatory functions
- Quality assurance and quality control of medicines
- Medicine registration and evaluation, quality assurance/quality control and clinical trials oversight
- Licensing of the manufacture, import, export, distribution and inspection and surveillance of manufacturers, importers, wholesalers and dispensers of medicine
- Clinical trials oversight
- Registration and evaluation and clinical trials oversight
- Medicine evaluation and registration
Read here for more information on the regulatory functions of RCOREs.