2024-06-16-亚开行-加强孟加拉国疫苗监管生态系统_形势和政策建议（英）_20页_619kb

Strengthening the Regulatory Ecosystem for Vaccines in Bangladesh

Bangladesh aims to enhance its regulatory capabilities to improve public health outcomes and support local vaccine manufacturing. Key challenges include delays in vaccine registration compared to high-income countries, limitations in regulatory processes, and infrastructure gaps. Opportunities exist to strengthen the regulatory lifecycle framework and align with global standards.

Current Regulatory Environment

The Directorate General of Drug Administration (DGDA) oversees vaccine regulation. Efforts include a five-year strategic plan and legislative reforms. Harmonization and digitalization of regulatory processes are needed to improve efficiency.

Opportunities for Improvement

Regulatory Life Cycle

• Preclinical and Clinical Research: Strengthen guidelines, laboratory practices, and workforce capacity.
• Registration and Marketing Authorization: Establish clearer timelines, adopt Common Technical Document (CTD) standards, and improve transparency.
• Manufacturing and Quality Control: Enhance Good Manufacturing Practices (GMP), invest in digital tools, and join international regulatory networks.
• Supply Chain Management: Improve storage infrastructure, implement traceability systems, and streamline import processes.
• Post-Market Surveillance: Strengthen pharmacovigilance systems, adopt standardized reporting formats (e.g., E2B(R3)), and enhance adverse event monitoring.

Key Policy Recommendations

1. Regulatory Framework Harmonization: Align with international standards and participate in regional initiatives.
2. Capacity Building: Implement training programs for regulatory personnel and develop a central training facility.
3. Infrastructure and IT: Upgrade laboratory and storage facilities, and leverage electronic systems for regulatory processes.
4. Enhance Regulatory Functions: Establish transparent timelines and implement self-assessment systems.

By addressing these areas, Bangladesh can build a robust regulatory ecosystem that ensures vaccine safety, efficacy, and availability, contributing to public health and economic growth.