19th International Conference of Drug Regulatory Authorities (ICDRA) Workshop Concludes in New Delhi

New Delhi: The second day of the 19th International Conference of Drug Regulatory Authorities (ICDRA) workshop held at the Yashobhoomi Convention Centre in Dwarka, New Delhi, wrapped up today, featuring a series of insightful technical presentations and moderated panel discussions focused on the regulatory frameworks of various agencies worldwide.

Inaugurated yesterday by Jagat Prakash Nadda, Union Minister of Health and Family Welfare, the 19th ICDRA is being hosted in India for the first time from October 14 to 18, 2024. The event is organized by the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, in collaboration with the World Health Organization (WHO). The conference has brought together regulatory authorities, policymakers, and health officials from numerous WHO member states to discuss pressing global health issues.

The primary aim of the 19th ICDRA is to facilitate focused discussions on various critical topics, including quality assurance, regulatory reforms, and the strengthening of regulatory systems. Key areas of concern include the safety of medical products, detection and prevention of substandard and falsified products, access to quality medical products, smart regulation of clinical trials, and the regulation of novel medical products, including herbal medicines.

During the workshop, speakers and panelists from countries including Singapore, Switzerland, South Africa, Brazil, Uganda, and many others delivered presentations on a wide array of topics. These included Access to Medical Products, Quality of Pharmaceutical Starting Materials, and the Regulation of Advanced Therapy Medicinal Products. The discussions emphasized innovative approaches, such as replacing, reducing, and refining dependence on animal studies, and improving access to medical devices through prequalification.

A significant update was provided by the African Medicines Agency on its operationalization, highlighting collaborative efforts across the continent.

The presentations aimed to enhance awareness regarding the quality of pharmaceutical starting materials and promote the establishment of robust regulatory frameworks for Advanced Therapy Medicinal Products. They also focused on creating opportunities for reducing reliance on animal studies, emphasizing the need for alternatives in drug development.

Additionally, the workshop addressed the processes of reliance and recognition through prequalification and the Collaborative Registration Procedure (CRP). Participants discussed the successes and challenges of implementing reliance for IVD pre-market approval and promoted the WHO Prequalification of Medicines (WHO PQT).