The South African Medicines Regulatory Environment

All medicines sold in South Africa have to be registered by the Medicines Control Council (MCC), a statutory medicines regulatory authority created by an Act of Parliament [27]. The MCC consists of 23 ministerially appointed members. The Council is supported by a series of nine expert committees, with a total of 146 members (including members of Council) [28]. In addition to the enabling Act, the operations of the MCC are governed by extensive regulations issued by the Minister of Health and by a detailed set of guidelines. The secretariat of the MCC is currently located within the National Department of Health. The MCC is required to only consider issues of quality, efficacy and safety, and there is no linkage between patent status and regulatory approval. The MCC is in the process of transitioning to a new structure, the South African Health Products Regulatory Authority. Under the new system, which will be co-funded from increased user fees, decision making will be done by the staff of the Authority, rather than the appointed members of the Council. The number of technically qualified staff is therefore expected to rise considerably, even though access to advice from external expert committees will still be possible. The legislation to give effect to these changes was passed by Parliament in late 2015 but has yet to be brought into effect [29].

Although accurate and updated data are difficult to access, it is known that there are considerable delays in the regulatory approval of medicines in South Africa. Delays ranging from 18 months to 3 years have been reported, affecting both new chemical entities and generic applications [23]. Although provision is made for an expedited approval process, it is unclear whether this has resulted in any faster approvals. The uncritical application of this procedure to all medicines that appear on the Essential Medicines List, regardless of how many equivalents are already registered, has been blamed by Leng et al. for exacerbating the backlog of applications at the MCC [30]. Leng et al. cited reports of a back-log of more than 3000 applications in 2010. They also provided data showing that, between 2007 and 2012, the MCC issued 149 marketing authorisations for new chemical entities, 18 for biological medicines, 2626 for generic medicines (of which 513 were ‘multiples’, where two or more dossiers for the same product were submitted, under different proprietary names). In this period, 14 new chemical entities and 158 generic medicines were registered via the expedited approval process. Critically, there is no publicly accessible register of medicines, showing all products for which a marketing authorisation has been issued by the MCC. It is also not possible to determine the basis for registration of generic medicines. A new Electronic Data Management System (EDMS) is under development but has yet to be fully implemented. Use of the electronic Common Technical Document (eCTD) format for dossier submissions is also being piloted.

Nonetheless, South Africa’s medicines regulatory system is considered to be of adequate quality, as shown by its membership of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), of which the South African Registrar of Medicines is the current chairperson [31]. As the PIC/S web site explains: ‘Before a regulatory authority can become a member of the PIC Scheme, a detailed assessment is undertaken to determine whether the authority has the arrangements and competence necessary to apply an inspection system comparable to that of current PIC/S members. This assessment involves an examination of the authority’s inspection and licensing system, quality system, legislative requirements, inspector training, etc., and is followed by a visit by a PIC/S delegation to observe inspectors carrying out actual GMP inspections.’

The MCC does not operate its own quality control laboratories but out-sources such services to the WHO-accredited Centre for Quality Assurance of Medicines (CENQAM), located at the North-West University [32]. The Centre is also a designated as the WHO Collaborating Centre for the Quality Assurance of Medicines. No data are available on the extent to which substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products have been detected or reported in South Africa.

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