The second day of the 19th International Conference of Drug Regulatory Authorities (ICDRA) workshop concluded on October 15, 2024, at the Yashobhoomi Convention Centre, Dwarka, New Delhi. The event, being held for the first time in India, runs from October 14 to 18, 2024. It is hosted by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare in collaboration with the World Health Organization (WHO). The ICDRA aims to foster discussions on improving regulatory frameworks, access to quality medical products, and ensuring patient safety through global regulatory cooperation.
Shri Jagat Prakash Nadda, the Union Minister of Health & Family Welfare, inaugurated the event on October 14, welcoming regulators, policymakers, and health officials from WHO member states. This year’s ICDRA brings together representatives from various regulatory authorities across the globe to discuss innovations, challenges, and harmonization efforts within medical product regulation. Countries participating in the event include Singapore, Switzerland, South Africa, Brazil, Canada, Uganda, Tanzania, the USA, Nigeria, Botswana, and many others.
Key Focus Areas of the 19th ICDRA Workshop
The 19th ICDRA is designed to facilitate technical discussions on essential issues affecting healthcare product regulation. It aims to explore quality control, regulatory reforms, and measures to ensure the safety and accessibility of medical products. Specific focus areas include:
• Regulatory frameworks for new medical technologies and novel products
• Detection, prevention, and response to substandard or falsified products
• Smart regulation of clinical trials and herbal medicines
• Harmonization, rationalization, and collaborative regulation across borders
• Access to quality medical products and advanced therapies
The workshop emphasized the importance of reliance-based regulatory systems and prequalification processes to expedite product access. Discussions also explored the need to replace, reduce, and refine reliance on animal testing. Representatives from agencies like the African Medicines Agency (AMA) shared insights on their progress toward operationalization.
Presentations and Global Collaboration
Speakers and panelists from countries including India, USA, Netherlands, Singapore, Kenya, and Tanzania delivered presentations covering a broad range of topics. Key sessions addressed:
• Access to affordable and high-quality medical products
• Regulatory frameworks for Advanced Therapy Medicinal Products (ATMPs)
• Quality control of pharmaceutical starting materials, especially high-risk components
• WHO’s role in prequalifying In Vitro Diagnostics (IVDs) and medicines to enhance market access
• Implementation of the Collaborative Registration Procedure (CRP) to streamline regulatory approvals
The presentations highlighted the importance of international collaboration and shared experiences from different regulatory environments. They also examined the challenges and successes of reliance models for pre-market approval of IVDs and other medical devices.
Panel Discussions and Recommendations
Following the presentations, the workshop included moderated panel discussions, question-and-answer sessions, and the finalization of recommendations. Participants emphasized the impact of regulatory pathways that facilitate quicker product introductions and promote the availability of essential healthcare products. The sessions provided a platform to share best practices and address common regulatory challenges faced by countries.
A key takeaway from the discussions was the need to create robust regulatory frameworks for emerging therapies while reducing regulatory bottlenecks through harmonized standards and global cooperation. WHO prequalification was also promoted as a tool for increasing access to quality medical products, particularly in low- and middle-income countries.
Future Directions and Closing Remarks
The ICDRA workshop serves as a critical platform for shaping future regulatory strategies. By fostering dialogue among global stakeholders, the conference aims to streamline regulations and promote access to innovative medical technologies. With India hosting this event for the first time, it underscores the country’s commitment to advancing healthcare through effective regulatory mechanisms and global cooperation.
(Input From Various Sources)
(Rehash/Ankur Deka/MSM)