The National Department of Health, in collaboration with the World Health Organization (WHO), convened a high-level workshop today at Dixies Bungalow to review the Draft Medicines Bill and align the Corrective and Preventive Actions (CAPA) Plan with the Institutional Development Plan (IDP) for Papua New Guinea’s medicines regulatory system.
The workshop was officially opened by Dr Dora Lenturut, Deputy Secretary for National Health Standards & Compliance, and Mr Vali Karo, Acting Manager of the Pharmaceutical Services Standards Branch (PSSB). Participants included representatives from the National Department of Health—including PSSB, disease programs, procurement, and the legal team—as well as the Central Provincial Health Authority (PHA).
“This workshop marks a critical step in institutionalizing regulatory improvements and ensuring that our legal and operational frameworks support the delivery of safe, effective, and quality-assured medicines,” said Dr Masahiro Zakoji, WHO Officer-in-Charge, who delivered opening remarks on behalf of WHO.
Dr Dora Lenturut emphasized two critical priorities for Papua New Guinea’s medicines regulatory reform:
- Ensuring access to quality medical products is essential for safeguarding the health and safety of the population.
- Inclusion of traditional and complementary medicine products must be given due consideration in the legislative and regulatory framework to reflect the realities of healthcare practices in PNG.
The workshop builds on the momentum of the 2024 Global Benchmarking assessment, which led to the development of the Institutional Development Plan (IDP)—a strategic roadmap for strengthening regulatory functions in line with national health priorities.
Papua New Guinea is the first Pacific Island Country to initiate CAPA planning, demonstrating its commitment to regulatory reform. The CAPA process provides a structured mechanism to address gaps in technical capacity, infrastructure, and governance, while the revised Medicines Bill will ensure that regulatory functions are legally mandated, transparent, and enforceable.
“The integration of CAPA actions into the Medicines Bill is essential for safeguarding public health and protecting our population from substandard and falsified medicines,” said Mr Karo.
The workshop provides an opportunity to refine CAPA priorities, revisit the IDP, and ensure that legislative reforms are contextually relevant and aligned with international best practices.
WHO reaffirmed its commitment to supporting Papua New Guinea through technical guidance and capacity-building initiatives.
“We encourage all participants to actively contribute to shaping a robust and responsive regulatory system that meets the needs of the people of Papua New Guinea,” Dr Zakoji added