Source: Asia Development Bank
Strengthening regulatory frameworks is critical in ensuring that vaccines are quickly approved and distributed. Using a systematic approach, gaps in key areas of the regulatory system can be identified, prioritized, and effectively addressed through regulatory capacity building and education of regulatory professionals.
The World Health Organization Global Benchmarking Tool was developed to evaluate regulatory systems objectively and systematically, identify strengths and areas for improvement, guide interventions, and monitor progress in strengthening the regulatory system. Consistent and regular training of national regulators can also complement regulatory systems strengthening efforts by focusing on the identified gaps.
The diverse and fragmented regulatory environment in Asia and the Pacific calls for regulatory convergence[1] and cooperation to facilitate timely and equitable access in the region. Stable, well-functioning national regulatory authorities in the region listed as WHO Maturity Level 3 and 4 and WHO Listed Authorities, such as those in the People’s Republic of China, India, Indonesia, Republic of Korea, Singapore, Thailand, and Viet Nam, could foster regional regulatory cooperation and serve as reference agencies for lower-resourced regulatory agencies.
Such cooperation could be facilitated by formalized processes and relationships such as memoranda of understanding. For example, Singapore’s Health Sciences Authority has adopted a confidence-based regulatory approach that leverages the decisions of established and trusted regulatory agencies through formal recognition mechanisms and has expedited reviews without compromising the robustness of regulatory decisions. This has reduced approval timelines to 90 working days from 270 working days for the Health Sciences Authority’s full evaluation route under its verification evaluation system.
Confidence-based approaches can be adopted in various stages of the vaccine life cycle. The ASEAN Mutual Recognition Arrangement on Good Manufacturing Practice Inspection enables member states to leverage on the regulatory inspections performed by other member states. It is legally binding for member states to recognize one another’s good manufacturing practice certificates, benchmarked against the international Pharmaceutical Inspection Cooperation Scheme.
Regulatory cooperation can range from legally-binding mechanisms in the form of mutual recognition agreements and reliance mechanisms to other forms of cooperation such as joint collaborative assessments, report sharing and work sharing. Work sharing can promote mutual learning and the sharing of best practices among participating national regulatory authorities and can encourage regulatory convergence. For industry, the work-sharing model can be commercially attractive, providing simultaneous access to multiple countries and shorten timelines with the consolidation of questions.
While cooperation on vaccine regulation is still nascent, there are other examples of regulatory cooperative mechanisms. Work sharing is practiced by Access Consortium, comprising the national regulatory authorities of Australia, Canada, Singapore, Switzerland and the United Kingdom. A similar coalition is the Opening Procedures at EMA to Non-EU authorities (OPEN) initiative, led by the EMA, which partners Australia, Brazil, Canada, Japan, Switzerland and WHO in joint assessments. In Asia and the Pacific, the Indo-Pacific Regulatory Strengthening Program, comprising Cambodia, Indonesia, Laos, Myanmar, Papua New Guinea, Thailand, and Viet Nam, and supported by Australia, successfully expedited approval of the antimalarial tafenoquine in Thailand in 2019 in its joint review.
While the work-sharing model has its advantages, the following points also need to be considered:
- Participating national regulatory authorities may have different priority drug lists and approval timelines.
- Participating national regulatory authorities may have different technical requirements.
- Lack of clarity in regulatory decisions could impact company filing strategies.
Convergence of regulatory requirements can further contribute to successful work-sharing collaborations. One way to incentivize the alignment of key regulatory requirements is the creation of a consensus on indicators that measure overall efficiency of the work-sharing pathway, which participating countries can jointly work towards. Regional regulatory convergence efforts include the APEC Action Plan on Vaccination Across the Life-Course, which sets key policy targets to achieve by 2030. Priorities for alignment include post-approval change management, labeling, and packaging.