Op-ed by Dr Ahmed Jamsheed Mohamed, WHO Representative to Bangladesh
When a mother brings her child for vaccination, she rarely thinks about the science behind the vial of vaccine or the regulatory checks completed long before that moment. She trusts that the vaccine is safe and will protect her child.
That trust underpins public health. Every day, millions of people across Bangladesh rely on medicines and vaccines without seeing the system that ensures they are safe, effective and of assured quality. At the heart of that system is the Directorate General of Drug Administration (DGDA), Bangladesh's National Regulatory Authority (NRA).
The DGDA – and with it, Bangladesh – is now on the threshold of a critical milestone: achieving World Health Organization (WHO) Maturity Level 3 (ML3) for vaccine regulation. ML3 is an internationally recognized benchmark demonstrating that a regulatory system is stable, well-functioning and capable of consistently protecting public health. Only a select group of NRAs worldwide have attained ML3 or the higher Maturity Level 4, with some also recognized as WHO-Listed Authorities for specific regulatory functions.
In Bangladesh, health and well-being, the economy and overall health security stand to benefit from this certification. Countries with mature regulatory systems are better equipped to protect their populations from substandard and ineffective vaccines and other medical products. This strengthens confidence among patients and families that the vaccines and medicines they receive meet internationally recognized standards of safety, quality and effectiveness, leading to better health outcomes and increased human and economic development.
Effective regulation will also strengthen Bangladesh’s position in global health and life sciences markets, supporting economic diversification and long-term resilience. In 2025 Bangladesh spent approximately US$ 120 million procuring vaccines from international suppliers which could rise to around US$ 400 million by 2030 as routine immunization expands and new vaccines are introduced. Achieving ML3 will help reduce these costs, which is especially important as Bangladesh prepares to graduate from Least Developed Country (LDC) status and transitions away from LDC-related flexibilities in vaccine procurement.
For overall health security, ML3 will strengthen Bangladesh's ability to ensure timely, reliable and equitable access to vaccines during public health emergencies. The COVID-19 pandemic underscored the risks of relying on external vaccine supplies and the importance of combining strong regulatory systems with domestic manufacturing capacity.
These benefits are substantial, but the opposite is also true: delays in achieving ML3 status will constrain Bangladesh’s ability to realize the full health, economic and health security benefits that a mature regulatory system provide, and which the country is capable of unlocking.
Building a stronger regulatory system
Achieving ML3 for vaccine regulation would mark the successful completion of one journey and the beginning of the next. Since 2017, Bangladesh has strengthened its regulatory system by enacting the Drugs and Cosmetics Act 2023, updating regulatory procedures, strengthening inspection and laboratory capacity, and investing in workforce development.
This reflects a shared commitment across government, industry and development partners to strengthen oversight across the pharmaceutical sector, recognizing that achieving ML3 for vaccine regulation will lay the foundation for extending the same regulatory maturity to essential medicines. In a country where around 98% of medicines consumed are produced locally, and where pharmaceutical manufacturers export to around 150 countries, this is especially important.
But the journey is not yet complete, and the achievement is not yet secured. To reach ML3 for vaccine regulation by 2027, five priorities stand out.
First, Bangladesh must maintain momentum in implementing the ML3 Roadmap and the DGDA’s Institutional Development Plan, ensuring that reforms are completed on schedule and deliver measurable results.
Second, the Drugs and Cosmetics Act 2023 must be fully operationalized through the timely approval and implementation of a series of key drug regulations, providing the regulatory framework needed to support a mature and effective system.
Third, the DGDA must be equipped with the people and structure required to deliver its mandate. This includes approving the revised organogram and filling critical human resource gaps.
Fourth, regulatory functions must be backed by adequate and sustainable financing. A high-performing regulatory authority depends not only on sound policies but also on the resources to implement them effectively.
Fifth, a high-level national task force should oversee implementation of the Roadmap, coordinate action across ministries and agencies, and maintain momentum towards the 2027 target.
This journey is about more than a global benchmark. It is about strengthening public trust, supporting a world-class pharmaceutical sector and strengthening health security.
Above all, it is about ensuring that every mother who brings her child for vaccination can be confident that the vaccine is safe and will protect her child – the true measure of success.