Portia Nkambule

Chief Regulatory Officer, South African Health Products Regulatory Authority

I am a pharmacist (B. Pharm degree, University of the Witwatersrand) with Master’s degree in Public Health and have worked for the Medicines Control Council of South Africa within the Department of Health since 2000. I have experience in management, medicines regulations, protocol reviews, protocol amendment reviews, bioequivalence protocol reviews, Good Clinical Practice (GCP) inspections, pharmacovigilance (trained by World Health Organization Uppsala Monitoring Centre in Sweden), evaluation of package inserts and patient information leaflets for registration of medicines. I have acted as the Cluster Manager: Food Control, Pharmaceutical trade and product regulation on several occasions.

I was appointed Director of Clinical Evaluations and Trials directorate in 2012 in the Cluster: Food Control, Pharmaceutical trade and product regulation within the Department of Health. I was responsible for the oversight of Clinical Trials Unit, Clinical Evaluations Pre-Registration Unit, Clinical Evaluations Post Registration Unit, Pharmacovigilance Unit, and Section 21 Unit (unit responsible for authorization of the use of unregistered medicines). I was also overseeing the activities of the following expert committees of the Medicines Control Council: Clinical trials committee, Clinical committee and Pharmacovigilance committee. I also supported and participated in the following working groups and sub committees: Harmonization working group, Clinical Trials policy working group, Clinical Evaluation policy working group, Clinical Peer Review Group and Priority Review working group.

I am currently appointed as the Chief Regulatory Officer of the South African Health Products Regulatory Authority in South Africa. I am responsible for the regulatory functions of SAHPRA, including regulatory systems, registration of medicines (orthodox, veterinary and complementary medicines), vigilance, post marketing surveillance, licensing establishments, inspections, clinical trial oversight, lot releases of vaccines and authorization of unregistered medicines.

I have participated in the reviews of the Medicines and Related Substances Act 101 of 1965 and its regulations, development of clinical trial policies and guidelines, development of policies and guidelines for package inserts and patient information leaflets evaluations, pharmacovigilance policies, facilitated at the World Health Organization GTN/VQ Clinical Trials Authorization training course held in South Africa in 2009; participated in the WHO Global Benchmarking Tool (GBT) self-benchmarking training, participated as a WHO GBT assessor for the NRA and served as a panelist, chaired, co-chaired and presented at various conferences and workshops on regulation of medicines and clinical trials. I have represented our organization at the following local, regional and international forums:

1. The National Health Research Ethics Council – Council appointed by the Minister of Health in line with the National Health Act 61 of 2003. The Council advises the Department of Health on the management of health research ethics matters in South Africa.

2. SADC Heads of agencies regulators forum which provides technical advice and guidance on regulatory issues relating to medicines and health commodities in the SADC region. The Regulators’ Forum acts as the Project Steering Committee for medicines regulatory harmonization activities and supports implementation of regulatory harmonization initiatives and strengthening of the medicines regulatory capacity in the region in-line with the SADC pharmaceutical business plan.

3. Zazibona initiative which is a collaboration in medicine review between national medicines regulatory authorities of all participating countries in the SADC region.

4. The African Vaccine Regulatory Forum (AVAREF) which aims to strengthen ethics and regulatory capacity for clinical trials ensuring oversight of product development in African countries. I was a member of the AVAREF Steering Committee representing the SADC region.

5. The WHO Developing Countries Vaccine Regulatory Network which aims to support and promote the strengthening of the regulatory oversight during the clinical development of vaccines, authorization and inspection of clinical trials, evaluation of investigational products, evaluation of registration dossiers and post marketing surveillance in developing countries.

6. The African Medicines Regulatory Conference (AMRC) which seeks to position medical products regulation in Africa as a strategic framework for effectively contributing to Post 2015 development agenda and the African Union agenda 2063 by facilitating access to the needed medical products, vaccines and technologies.

7. Bi-annual Scientific Conference which reviews progress made with regards to medicines regulatory activities and actions for sustaining the momentum for regulatory systems strengthening and harmonization in Africa.

8. African Medicines Regulatory Harmonization (AMRH) programme of the African Union NEPAD which is a precursor of the African Medicines Agency (AMA) - Regulatory Capacity Development Technical Committee and Medicines Policy and the Regulatory Reform Technical Committee.





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