The second day of the 19th International Conference of Drug Regulatory Authorities (ICDRA) took place on 15th October 2024 at the Yashobhoomi Convention Centre, Dwarka, New Delhi. The day was filled with technical presentations and panel discussions that focused on global regulatory frameworks for drug safety and medical products.
Inauguration by Health Minister Jagat Prakash Nadda
The conference, being hosted for the first time in India, was inaugurated on 14th October 2024 by Union Minister of Health & Family Welfare, Jagat Prakash Nadda. The Central Drugs Standard Control Organization (CDSCO), part of the Ministry of Health and Family Welfare, is organizing the event in collaboration with the World Health Organization (WHO).
The conference, running from 14th – 18th October 2024, brings together regulatory authorities, policymakers, and health officials from various WHO member states. The goal is to have focused discussions on regulatory reforms, drug safety, and the improvement of medical product access.
Purpose of the 19th ICDRA
The conference aims to discuss several key areas, such as:
- Quality issues in medical products
- Regulatory system reforms
- Safety of medical products
- Detection and prevention of substandard and falsified products
- Access to quality medical products
- Regulation of novel technologies and herbal medicines
- Smart regulation of clinical trials
The discussions are designed to strengthen regulatory frameworks globally and ensure the safe, reliable, and effective use of medical products.
Countries Participating in Discussions
Speakers, co-moderators, and panellists from various countries, including Singapore, Switzerland, South Africa, Brazil, Uganda, Tanzania, Netherlands, Canada, Zambia, Zimbabwe, Thailand, El Salvador, Nigeria, USA, Ghana, Kenya, Botswana, Denmark, and India, shared their expertise.
These experts delivered presentations on topics such as:
- Access to medical products
- Quality of pharmaceutical starting materials
- Regulation of advanced therapy medicinal products
- Replacing animal studies with alternative research methods
- Improving access to medical devices through prequalification and reliance
The African Medicines Agency (AMA) also provided an update on its operationalization during the workshop.
Key Objectives of Presentations
The main focus of these presentations was to increase access to medical products through improved regulatory pathways. Some of the core objectives discussed include:
- Raising awareness about the quality and safety of pharmaceutical starting materials
- Promoting the establishment of regulatory frameworks for Advanced Therapy Medicinal Products (ATMPs)
- Replacing and refining reliance on animal studies in drug development
- Enhancing prequalification processes for medical devices and medicines
- Collaborative Registration Procedure (CRP) to ensure pre-market approval of medical products in various countries
Insights from Panel Discussions
The day concluded with moderated panel discussions, where global experts exchanged their thoughts on the day’s topics. These discussions were followed by Q&A sessions, allowing participants to share their questions and concerns. The day wrapped up with the finalization of recommendations for improving global regulatory systems and increasing access to safe medical products.
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