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Healthcare, Pharma & Life Sciences

Pharmaceutical & Life Sciences

SAHPRA regulates the registration, manufacture, import, and clinical trials of all medicines and medical devices in South Africa. Non-compliance carries product seizure, licence suspension, and criminal liability. GMP (Good Manufacturing Practice) compliance is the foundational manufacturing obligation.
Applicable legislation

Key legal frameworks

Medicines & Related Substances Act 101 of 1965 (as amended)
Pharmacy Act 53 of 1974
National Health Act 61 of 2003
Consumer Protection Act 68 of 2008
POPIA (clinical trial data and patient records)
Regulators

Who oversees this industry

SAHPRA. South African Health Products Regulatory AuthoritySAPC. South African Pharmacy CouncilDepartment of HealthEthics Review Committees (clinical trials)
King V principles most affected
P4. ReportingP8. RiskP9. Compliance
What Encircle tracks for Pharmaceutical & Life Sciences
SAHPRA medicine and medical device registration compliance
GMP compliance, manufacturing, storage, and distribution
Clinical trial authorisation and ethics committee approval
Adverse event / pharmacovigilance reporting to SAHPRA
SAPC pharmacy practice and responsible pharmacist obligations

Your Pharmaceutical & Life Sciences industry profile

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