South African GMP — Medicines and Related Substances Act
The South African Health Products Regulatory Authority (SAHPRA) regulates medicines and medical devices under the Medicines and Related Substances Act 101 of 1965 (as amended), licensing manufacturers and importers and inspecting them for GMP compliance. SAHPRA replaced the Medicines Control Council in 2018; South Africa has been a PIC/S participating authority since 1 July 2007 — the first in Africa — so SAHPRA applies the PIC/S GMP standard, and in 2022 it attained WHO Maturity Level 3 for vaccine regulation.
What this does not cover
stated in the document's own scope- Applies the PIC/S GMP Guide rather than a separate South African GMP code.
- Covers medicines and medical devices under Act 101 of 1965; other product classes fall outside this instrument.
- WHO Maturity Level 3 is a maturity classification, not the same as formal inclusion on the WHO-Listed Authority list.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
The South African Health Products Regulatory Authority (SAHPRA) regulates medicines and medical devices under the Medicines and Related Substances Act 101 of 1965 (as amended), licensing manufacturers and importers and inspecting them for GMP compliance. SAHPRA applies the PIC/S Guide to Good Manufacturing Practice as its GMP standard. It replaced the Medicines Control Council (MCC) in 2018 as a public entity with a wider remit, inheriting the MCC’s inspection and licensing functions and its place in the international GMP framework.
Scope & applicability
Manufacturers and importers of medicines and medical devices supplying South Africa. Product registration is governed by SAHPRA under the same Act.
Legal basis & how it acquires force
The Medicines and Related Substances Act 101 of 1965 is South Africa’s binding medicines statute; it enables the licensing of manufacturers and importers, the registration of medicines, and the regulation of medical devices, and it establishes SAHPRA as the authority that administers them. A manufacturing or import licence is a legal requirement, conditional on GMP compliance that SAHPRA verifies by inspection. The Act and its regulations, not guidance, are the source of the obligation.
Document structure
| Part | Covers |
|---|---|
| Licensing framework | Manufacturer and importer licences issued under Act 101 of 1965 |
| Adopted GMP standard (PIC/S Part I) | Basic requirements for medicinal products — quality system, personnel, premises, documentation, production, and quality control |
| Adopted GMP standard (PIC/S Part II) | Basic requirements for active substances used as starting materials |
| Annexes | The PIC/S annexes applied to specialised operations such as sterile manufacture |
| Registration and inspection | Medicine registration under the Act and SAHPRA’s GMP inspection programme |
Key requirements
- Hold a SAHPRA manufacturing or import licence under Act 101 of 1965.
- Comply with the PIC/S GMP standard SAHPRA applies.
- Maintain the quality-system, qualification, and validation documentation required for licensing and inspection.
Implementation tips
- SAHPRA inherited the Medicines Control Council’s PIC/S membership — GMP evidence from other PIC/S authorities supports South African licensing.
Revision notes
SAHPRA succeeded the Medicines Control Council in 2018; South Africa acceded to PIC/S in 2007, and SAHPRA reached WHO Maturity Level 3 for vaccines in 2022.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
South Africa has been a PIC/S participating authority since 1 July 2007 — the first member from Africa — a status SAHPRA carries forward from the Medicines Control Council, so its GMP standard is the PIC/S Guide that mirrors EU GMP. In 2022 SAHPRA attained WHO Maturity Level 3 for vaccine regulation, one step in the WHO classification that makes an authority eligible, after further evaluation, for the WHO-Listed Authority list — a recognition of a stable, well-functioning regulatory system rather than the same thing as full listing.
Act 101 of 1965 (GMP): frequently asked questions
Quick answers to common questions about Act 101 of 1965 (GMP).
What law does SAHPRA regulate under?
The Medicines and Related Substances Act 101 of 1965 (as amended). It enables manufacturer and importer licensing, medicine registration, and device regulation, and establishes SAHPRA as the administering authority.
Is South Africa a PIC/S member?
Yes. South Africa has been a PIC/S participating authority since 1 July 2007 — the first from Africa — and SAHPRA carries that membership forward from the Medicines Control Council it replaced in 2018.
What does SAHPRA’s WHO Maturity Level 3 mean?
In 2022 WHO assessed SAHPRA at Maturity Level 3 for vaccine regulation, meaning a stable, well-functioning, integrated regulatory system. ML3 makes an authority eligible, after further evaluation, for the WHO-Listed Authority list; it is not the same as full listing.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.