HeDPAC Supports Guyana’s Efforts to Build a Stronger Medicines Regulatory System

August 2026

Georgetown, Guyana

The Health Development Partnership for Africa and the Caribbean (HeDPAC) has deepened its technical engagement with the Government of Guyana, with a focus on strengthening the country’s medicines regulatory system and the institutional capacity of the Guyana Food and Drug Department (FDD). The engagement took place during a HeDPAC technical mission to Guyana from 31 July to 8 August 2026, within the framework of its partnership with the Ministry of Health.

Supporting a stronger medicines regulatory system

A central component of the mission was engagement with the leadership and technical teams of the FDD. On 6 August, the HeDPAC delegation met with FDD Director General Ms. Tandeka Barton to gain a better understanding of the Department’s regulatory mandate, institutional capacity, ongoing reforms and priorities for technical support.

The discussions highlighted Guyana’s ongoing efforts to modernize its medicines regulatory system. The FDD currently regulates food, medicines, cosmetics and medical devices and has 49 staff. An institutional reform process is underway to separate food regulation from the regulation of medicines, cosmetics and medical devices, with the latter remaining under the Ministry of Health.

Strengthening regulatory and inspection capacity was identified as a priority. The Department currently has 11 inspectors, including two senior inspectors, placing significant demands on available staff. Plans are underway to recruit additional personnel in line with a proposed new organizational structure.

HeDPAC’s engagement seeks to complement these national reform efforts through targeted technical assistance and institutional capacity development. As part of this collaboration, a Technical Advisor has been recruited through HeDPAC’s technical assistance to the Ministry of Health to support the FDD.

Advancing regulatory legislation and WHO GBT readiness

Strengthening the legal foundation for medicines regulation is another key priority. Guyana is developing a new Drug Bill to provide a stronger legislative basis for medicines regulation.

The draft legislation has undergone stakeholder consultations, including with the private sector and pharmaceutical associations. The mission identified opportunities for further technical input to strengthen the Bill’s alignment with the World Health Organization’s Global Benchmarking Tool (GBT) requirements while ensuring that it reflects Guyana’s national regulatory priorities.

HeDPAC will explore opportunities to provide continued technical support to address identified gaps and support the progression of the legislation towards adoption and effective implementation.

Building regulatory capacity for a growing pharmaceutical sector

The importance of regulatory strengthening was further underscored during the delegation’s meeting with Hon. Dr Anthony Frank, Minister of Health, on 7 August 2026.

The Minister reaffirmed the Government’s commitment to strengthening the legal, institutional and technical foundations of the country’s medicines regulatory system, including legislation, organizational structures and laboratory capacity. He emphasized the importance of a robust regulatory framework to oversee the importation of medicines and health products and the export of locally manufactured products.

This priority is closely linked to Guyana’s ambition to become a biomanufacturing hub for the region. The Government is considering an initial focus on the production of essential products, including intravenous fluids and peritoneal dialysis fluids. Strengthened regulatory capacity will be essential to ensuring that locally manufactured products meet appropriate standards of quality, safety and efficacy and can access regional markets.

Digital transformation and interoperable regulatory systems

The discussions also highlighted the importance of digital transformation in medicines regulation and supply management.

The Minister emphasized the need to transition from paper-based processes to an electronic inventory and tracking system for medicines and health-product imports, with interoperability across relevant government platforms, including customs and other institutions involved in importation and clearance.

Such systems would strengthen traceability, transparency and regulatory oversight while improving inventory management and monitoring of medicines and health-product flows.

Expanding laboratory capacity

Laboratory capacity is another important pillar of Guyana’s regulatory development agenda. The FDD’s regulatory laboratory is accredited for conformity assessment, with technical support from the Caribbean Public Health Agency (CARPHA).

Plans are underway to expand laboratory capacity through four additional laboratories or units, including facilities for cosmetics, analytical testing and pharmaceutical drug testing. A new four-storey facility is also being developed with support from the European Union and PAHO, alongside additional technical assistance through an EU-supported initiative.

These investments will provide an important foundation for strengthening the technical functions required for a modern and effective regulatory system.

Linking regulation, local production and regional access

The mission highlighted the broader strategic importance of medicines regulation within Guyana’s health and economic development agenda. As the country advances its ambitions for local pharmaceutical and biomanufacturing, regulatory capacity will be increasingly important to ensuring appropriate oversight of locally produced health products and supporting their potential access to regional markets.

The Minister also highlighted the importance of pooled procurement mechanisms, including Guyana’s engagement with the PAHO Strategic Fund and Revolving Fund, to support reliable access to quality-assured medicines and improve procurement efficiency.

Deepening Partnership for Continued Technical Cooperation

The mission builds on the ongoing collaboration between HeDPAC and Guyana’s Ministry of Health and provides a foundation for continued technical assistance in priority areas including regulatory legislation, institutional development, inspection and laboratory capacity, digitalization and regulatory preparedness for local pharmaceutical manufacturing.

As Guyana advances its ambition to strengthen domestic production and expand regional access to essential health products, a capable, modern and internationally aligned medicines regulatory system will be critical to safeguarding quality and safety while enabling pharmaceutical development and regional health security.