Eswatini has achieved a key health system milestone with the formal establishment of the Medicines Regulatory Authority (MRA) following the unveiling of its Board today, January, 8, 2026 by the Minister of Health, Hon. Mduduzi Matsebula. This institutional development transitions the former Medicines Regulatory Unit into a fully empowered statutory authority tasked with oversight of medical products.

 

 

Legal basis for the Authority

The MRA is established under the Medicines and Related Substances Control Act No. 9 of 2016, which provides for the creation of an independent regulatory authority to oversee medicines, medical devices, complementary medicines, and scheduled substances in the Kingdom of Eswatini. The Act outlines the functions, governance and board composition of the Authority, and provides the framework for its operations.

Mandate and regulatory scope

Once fully operational, the MRA will be responsible for:

    • Registration of medicines, medical devices and complementary medicines, ensuring products meet national standards for quality, safety and efficacy.

    • Regulating labelling requirements, helping ensure accurate and clear product information for users.

    • Oversight of advertising and promotional practices for medical products.

    • Regulating the sale and distribution of medicines and controlling scheduled substances across the health system.

These responsibilities bring Eswatini in alignment with international expectations for a national medicines regulatory authority and strengthen the legal framework for product oversight.

Implementation roadmap and current progress

Although the Act was passed in 2016, the establishment of the MRA was delayed by funding, technical and structural challenges, and required enabling regulations before full enforcement. According to legal analysis of the Act, implementation depends on subsidiary regulations that are to be developed and approved by the Minister of Health. These regulations determine when specific provisions of the Act come into force and support organisational readiness.

Recent government reporting confirms that the Medicines Regulatory Unit has been working to implement recommendations from health product regulatory system assessments and prepare for the transition to a full Authority. These efforts include drafting policies, guidelines and operational procedures required for the MRA’s functions.

Strengthening regulatory governance

The formalisation of the MRA as a statutory authority enhances regulatory governance by providing:

    • Legal autonomy and clear accountability for decision making.

    • A structured governance framework through a Board with defined expertise.

    • Capacity to enforce regulatory actions, policy and compliance across the health products sector.

This transformation supports broader health system objectives, improving oversight, transparency and alignment with regional regulatory harmonisation efforts.

Public health impact

A functioning national regulatory authority is essential for safeguarding public health. It helps prevent the circulation of substandard or falsified products, supports efficient market authorisation processes, and improves confidence among healthcare providers, patients and stakeholders in the pharmaceutical and medical device sectors.

Looking ahead

With the MRA now established and board members appointed, Eswatini advances toward full regulatory implementation. Key next steps include finalisation and enactment of the regulations that enable the Authority’s mandates, staffing and operational readiness, and ongoing engagement with regional and international partners to strengthen regulatory systems.

The establishment of the MRA marks a critical step in the Kingdom’s commitment to ensuring safe, effective, and quality medical products for all.