The Biological Medicines Evaluation and Research Unit (BMERU) is a sub-unit of Medicines Evaluation within the South African Health Product Regulatory Authority (SAHPRA).
On the 15th of November 2013, the Minister of Health published amendments to the General Regulations made in terms of the Medicines and Related Substance Act, 1965 (Act 101 of 1965) (hereafter referred to as “then General Regulations”), which established a category of medicines, Complementary Medicines (Category D) and effectively established a regulatory framework for this category.
The Clinical Trial Unit of the South African Health Products Regulatory Authority (SAHPRA) provides legal framework for the review of clinical trials and Bioequivalence studies for human participants and recommends approval of the conduct of clinical trials.
The main purpose of this programme is to ensure public access to health products that comply with quality standards through inspections. The focus of this programme is on the assessment of site compliance, with current good regulatory and vigilance practices.
The medical device unit of SAHPRA regulates the licencing of medical device establishments and the registration of medical devices (In vitro diagnostics (IVDs) and non-IVD medical devices) in South Africa to ensure the availability of medical devices that comply with an acceptable level of safety, quality and performance.
The Names and Scheduling Unit of SAHPRA evaluates the suitability and applicability of any proprietary name proposed to be used in connection with a medicine and evaluates the scheduling status of a medicine.
Radiation Control regulates all activities involving electronic generators of ionising radiation as well as radioactive sources used outside the nuclear fuel cycle.
No therapeutic product is ever completely risk free. Some risks may be known when a medicine is first entered on the market. However, some information only comes to light after more people use the products.
The Section 21 Unit (Orthodox Medicines for Human Use) of the South African Health Products Authority (SAHPRA) processes and evaluates applications from applicants (treating practitioners) for access to unregistered medication within South Africa (SA).
