Introduction
The Health Products Association (HPA), established in 1976 as a voice for the industry, has consistently acted as the representative body for companies in the natural health, nutritional supplement, and traditional medicine sectors, advocating for a rational, risk-based regulatory framework suited to these products.
Since the 1980s, the Association and other industry groups have collaborated with the various authorities and regulators, motivating for regulations that are appropriate to the paradigms of health supplements, traditional medicines and other non-allopathic health and belief systems. In every instance, the intention has been for regulations that ensure safety, quality and efficacy of products, affordability and choice for consumers and a supportive environment for sustainable businesses.
Foundational Years (1980–1989)
In the mid-1980s, tensions between the allopathic medical community and natural medicine practitioners was exemplified by the Minister of Health publicly declaring homeopathic medicines “ineffective and dangerous”, signalling a potential removal from the market. This provoked a major industry response: a delegation of South African homeopathic and natural health experts travelled to Europe and the USA in 1986 to study regulatory models abroad. Their findings were striking — no country applied a uniform or scientifically coherent system for regulating homeopathic or complementary medicines. This reinforced the need for South Africa to develop its own rational, evidence-informed approach.
In 1987, the first MCC Homeopathic Committee was constituted under the Medicines Control Council (MCC) to regulate homeopathic products responsibly. The committee comprised a homeopathic practitioner, a medical doctor, a lawyer, and an industry representative. Its work produced the so-called “pink list” of approved substances and indications, establishing the principle of regulating complementary medicines (CMs) based on safety, quality, and efficacy rather than pharmaceutical paradigms.
Expansion to the Complementary Medicines Committee (1990s)
In the early 1990s, the MCC recognised that the principles established for homeopathy could apply to other natural modalities — including herbal, Ayurvedic, Unani Tibb, anthroposophical, and nutritional systems — and therefore broadened the committee’s scope. The Complementary Medicines Committee (CMC) replaced the Homeopathic Committee, marking the first formal acknowledgment that complementary medicines required their own regulatory approach distinct from pharmaceuticals.
By 1996, broad stakeholder consultations between the Department of Health (DoH), the MCC, and the HPA led to a new “wide” Complementary Medicines Committee representing all paradigms. For the first time, stakeholder input was institutionalised through Broad-Based Reference Groups (BBRGs), allowing different traditional and complementary disciplines to participate in the regulatory process.
Key developments from this period included:
- Recognition that complementary medicines differ fundamentally from orthodox medicines and that access and availability to the public must be protected.
- Early development of an electronic lodgement system, modelled on the Therapeutic Goods Administration (TGA) in Australia, to facilitate rapid listing of products according to pre-approved substances and indications.
- Broad consensus between the MCC and industry on implementing this “listing procedure” as a pragmatic control system.
The SAMMDRA Act (1997–1998)
In 1997, under Registrar Prof. Johann Schlebusch, the MCC, with HPA collaboration, was ready to implement a comprehensive system of listing, safety schedules, approved ingredients, and permissible claims. However, sweeping administrative changes within the DoH halted progress. Senior officials involved in the project were replaced, and the implementation was indefinitely postponed.
In 1998, the South African Medicines and Medical Devices Regulatory Authority (SAMMDRA) Act was passed and signed into law by President Nelson Mandela. SAMMDRA would have created four independent boards — one specifically for Complementary and Alternative Medicines (CAMs). It introduced the concepts of graded control (G0–G3) and a dual-track system allowing fast listing for low-risk products and full review for higher-risk ones. The Act was supported by Parliament and accepted by the MCC, ANC Health Study Group, and the Parliamentary Portfolio Committee.
However, the SAMMDRA Act never came into operation because the accompanying regulations were not finalised. The change in MCC membership and secretariat that followed resulted in institutional memory loss and a complete halt to implementation.
Repetition and Stagnation (1998–2007)
Between 1998 and 2002, the HPA worked closely with successive MCC working groups to resurrect the listing model. Despite several drafts of proposed amendments to Act 101, none were enacted. In 2002, the MCC appointed consultant Peter Kreft, who prepared a comprehensive documentation package outlining the rationale, grading systems, adverse reaction reporting, and technical standards required for CAM regulation. In addition, “Listing Software” with a web interface was written.
On 22 February 2002, the MCC issued a “Call-Up Notice”, requesting all companies to submit applications for their complementary medicines. The industry responded by preparing dossiers using the informal listing structure aligned with international models. The Registrar later described this as a “first step toward registration”.
However, in the absence of statutory amendments, the call-up lacked legal clarity. Submissions were treated as reference material, and none were formally evaluated.
From 2004–2007, the DoH published new draft regulations that ignored the negotiated listing model. These drafts required complementary medicines to comply with the same stringent framework as pharmaceuticals, an approach the industry strongly opposed. Industry stakeholders mobilized under the Complementary Medicine Stakeholder Committee to oppose these regulations, successfully halting their publication. During this period, industry continued with the 2002 call-up process including the use of the accepted claims and substances with associated wording as per the listing system. Lists were further developed and updated by industry, the HPA and MCC.
Attempts at Renewal (2008–2011)
In 2008, a new set of draft regulations introduced a separate “Category D” for Complementary Medicines. These included a proposed fast-track registration and screening system, which the HPA provided comment on. However the regulations were never promulgated.
The MCC passed a resolution to rescind the 2002 call-up and the HPA lodged an appeal against this decision. No hearing took place, but a negotiated settlement was reached, resulting in no call-ups would take place yet. The 2002 call-up submissions were allowed to continue, with a more intense review of each application during 2010, which was welcomed by Industry.
By 2011, the HPA had developed a comprehensive regulatory proposal, including:
- Low-risk products: Simple listing based on accepted ingredients and claims.
- Medium-risk products: Simplified review.
- High-risk products: Full registration.
- Risk-based GMP: using Food Supplement GMP aligned with ISO 22000.
- Introduction of a Responsible Person model under the Companies Act, rather than a pharmacist-only system.
The 2013–2018 Regulatory Crisis
The 2013 regulations, followed by amendments in 2017, formalised the classification of complementary medicines under Category D of the Medicines Act. These regulations subjected even low-risk vitamins, minerals, and herbal supplements to pharmaceutical-level Good Manufacturing Practice (PIC/S GMP), eCTD and full registration processes.
The HPA filed extensive objections and participated in consultations, arguing that:
- Health supplements should fall under Food Law, in accordance with the Codex Alimentarius (CAC/GL 55–2005).
- Complementary Medicines required a distinct regulatory directorate with its own Registrar and simplified pathways.
- Responsible Person designations should be broadened beyond pharmacists.
- GMP requirements should be modified to include food safety certifications such as FSSC 22000, BRC, ISO 22000, or equivalent.
These new regulations were published with no period for comment offered. In addition, they replicated the 2004 drafts almost verbatim, which prompted the HPA’s legal challenge in 2014. The validity of the regulations were challenged, arguing they were unlawfully enacted, without consultation. The case resulted in a rift between the HPA and SAHPRA (which was the successor to the MCC), leading to a loss of formal engagement between the two entities.
Several updates to the Regulations and Guidelines were published with almost zero engagement with the HPA. In order to re-establish contact with the Regulator, litigation was suspended. The HPA provided extensive comment to the newly published regulations, but received no feedback. Various forums were set up to engage with the Regulator, but the Regulator stood by the Regulations with no changes.
In 2016 further draft regulations were published for comment. Some of the changes proposed by the HPA were accepted, but the regulations were not promulgated. At this time, complementary companies were not able to launch new products without full registration, stifling the industry.
Further Regulations were published for comment, with a deadline for comment of January 2017, followed by updated Annexures and Guidelines. The HPA commented on all. On 25 August 2017, the General Regulations to the Medicines and Related Substances Act, 101 of 1965 (Regulations, 2017) were published.
Section 54 of these Regulations repealed the regulations published under Government Notice No. R510 of 10 April 2003. In terms of this,
- Health Supplements were included into the Regulations, with no change to Allopathic standards
- Comments on the requirements for licencing, Responsible Pharmacist, the registration process, CTD and others also were ignored.
The HPA surveyed its members regarding the expected costs of CTD, finding
- Approximate costs for a single active ingredient tablet could vary between R105 000 – R210 000 per product
- For multiple ingredient tablets, which formed the majority of products on the market, approximate per product costs varied between R277 000 and R431 000.
Clearly this was going to be unaffordable for complementary medicines companies and was likely to cripple the industry.
Industry continued to comment on the inappropriateness of legislation as it was published. On 12 June 2018, at a meeting between the SAHPRA CEO and the complementary medicines industry, the HPA presented the industry’s concerns. Following the meeting the HPA was invited to form an independent complementary medicines working group to engage with SAHPRA. Through this forum the HPA requested exemptions from 18A, 18B and 22G of the Act, down scheduling of certain substances and voiced concerns with CTD, the definitions, guidelines, fees and others.
2019-2022: ANHP / SAHPRA / NDoH Court Case
During this period, the HPA, chaired the Industry Technical Group (ITG) which interfaced with SAHPRA on all items, proactively attempting to raise awareness with SAHPRA on all the issues of concern. The HPA introduced a globally accepted minimum standard for Good Manufacturing Process (GMP) and processes for wholesaling and distributing of low-risk category D products.
SAHPRA indicated they found them to be acceptable in principle, but to date have not published them in the guidelines.
In March 2021 the HPA and the DSA met with SAPC to request that, in certain types of complementary medicines companies, a Responsible Person be permitted to fulfil the role of a Responsible Pharmacist, due to the lack of a functional role and inappropriateness of a person with this training. The HPA was referred to the Minister of Health and a submission was made in June 2021.
To date, no response has been received, despite multiple requests for a decision on this matter.
Despite no remedy being in provided, SAHPRA released multiple new guidelines, including:
- Guideline 7.02 (Roadmap)
- Guideline 7.04 (on product submission and registration processes),
- Guideline 7.06 (addressing advertising and labeling),
- Borderline Products Guideline,
- New Appeal Procedures
- Licence application guidelines
- Certificate of Free Sale
The HPA responded to each through formal submissions via the ITG, and used the opportunity to argue that the requirements in the licence application guideline were overly aligned with the pharmaceutical model and ignored existing food supplement GMP standards.
In January 2022, the HPA submitted an Internal Appeal in terms of section 24A(1) of the Medicines Act. The grievances were multi-faceted, incorporating most of the issues raised over the years with SAHPRA regarding the regulations and guidelines.
The Alliance of Natural Health Products (ANHP) / SAHPRA / Minister of Health appeal case, was heard in the Supreme Court of Appeal in April 2022. SAHPRA and the Minister of Health lost the case, with costs. Complementary medicines that did not make therapeutic claims were ruled to not be medicines and should therefore not be regulated as a medicine. The Minister was given 12 months to provide a remedy. To date, no remedy has been provided.
2023: Consolidated Industry Advocacy and Regulatory Response
Throughout 2023, the HPA intensified its policy work, chairing the Industry Technical Group and coordinating regular engagements with SAHPRA officials. The following key actions took place through the year:
- Publication of Draft Regulations (24 March 2023) – The HPA prepared a detailed written submission addressing definitional inconsistencies, excessive regulatory burdens, and the need for a distinct regulatory category for Health Supplements separate from Medicinal Products.
- June 2023: A direct meeting was held with the SAHPRA CEO, where the HPA presented a comprehensive outline of its concerns, including:
- The economic impact of current regulatory uncertainty;
- Proposals for an integrated listing model and transitional licensing approach;
- Concerns over the misapplication of the Common Technical Document (CTD) format to complementary medicines.
- December 2023: The HPA presented in person through a public participation process to present its concerns and comments to the regulations.
- In parallel, the HPA and the Direct Selling Association (DSA) jointly re-submitted formal applications to the Minister of Health requesting that the Responsible Person / Responsible Pharmacist requirements be reviewed and replaced with a more practical, inclusive framework.
2024: Continued Policy Engagement and Government Dialogue
In 2024 the HPA continued to chair the ITG and sustained its high-level advocacy and sector coordination. Key events and actions included:
- Resubmitted request to the Minister of Health (jointly with DSA) regarding the Responsible Person issue, which remained unanswered.
- Captains of Industry engagement (August 2024): HPA leaders Peter Kreft and Riel Malan attended the national Captains of Industry meeting, where SAHPRA’s COO publicly announced plans to adopt the Common Technical Document (CTD) system for complementary medicines. The HPA immediately warned that this would be administratively unworkable and inconsistent with low-risk product oversight.
- November 2024: SAHPRA issued written responses to questions raised by Peter Kreft at the August Captains of Industry meeting and hosted a CAMs industry workshop (21 November 2024) to explain its stance. The Authority reaffirmed its intention to maintain CTD-based submissions and stringent licensing, contrary to HPA’s position.
2025: Continued Advocacy and Awaiting Policy Outcomes
The year 2025 has been characterised by intense regulatory dialogue and continued uncertainty:
- The HPA continued to chair the Industry Technical Group, maintaining a proactive role in ensuring that all issues accumulated since 2019 remained on the policy agenda.
- SAHPRA’s CEO confirmed that draft amended regulations had been forwarded to the Minister of Health and that the Authority awaited ministerial feedback.
- Peter Kreft again raised the CTD issue at the Captains of Industry meeting (14 May 2025).
- The HPA met once more with the SAHPRA CEO, addressing strategic concerns including:
- The ongoing CTD requirement for complementary medicines;
- Borderline product guideline
- The lack of approvals received for Annexure B applications
- Port Health import detentions
- Free Sale Certificate delays.
- The HPA sent a formal letter to SAHPRA requesting collaborative engagement in developing a workable system for complementary medicine submissions before implementation.
- Between May and August news surfaced that the Minister of Health was to commission an economic impact study prior to signing the Regulations. The HPA submitted a formal request to the Minister for an expansion of the scope of the study, listing study areas it felt were essential to a comprehensive and credible result. The request has been confirmed as received by the Minister’s office, but no acknowledgment has yet been given that it will be incorporated into the study.
Conclusion
The complementary medicines sector’s history in South Africa reveals a 40-year struggle to achieve balanced, risk-based regulation aligned with global norms. The HPA’s consistent advocacy has sought to secure consumer safety while preserving access, protecting small manufacturers, and promoting product innovation.
The HPA’s proposed independent directorate model offers a pragmatic path forward — one that recognises the distinct nature of complementary medicines and aligns South Africa with successful international systems such as those in Australia and Canada.