The second day (15^th October 2024) of 19^th International Conference of Drug Regulatory Authorities (ICDRA) workshop happening in Yashobhoomi Convention Centre, Dwarka, New Delhi, concluded today. There were a number of technical presentations and moderated panel discussion on the regulatory framework of various regulatory agencies across the world.

Yesterday, Shri Jagat Prakash Nadda, Union Minister of Health & Family Welfare inaugurated the 19^th ICDRA. The event which is being hosted for the first time in India, from 14^th – 18^th October 2024 by the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, in collaboration with the World Health Organization (WHO) brought together regulatory authorities, policymakers, and health officials from different WHO member states.

The purpose of 19^th ICDRA is to facilitate focused discussions on quality issues, regulatory reforms and strengthening regulatory systems, safety of medical products, detection, prevention and response to substandard and falsified medical products, access to quality medical products, smart regulation of clinical trials, regulatory collaboration, harmonization, rationalization and reliance, access to new and novel technologies, regulation of novel medical products, regulation of herbal medicines, etc.

During the workshop, co-moderators, Speakers and panellists from different countries like Singapore, Switzerland, South Africa, Brazil, Uganda, Tanzania, Netherlands, Canada, Zambia, Zimbabwe, Thailand, El Salvador, Nigeria, USA, Ghana, Kenya, Botswana, Denmark, and India delivered presentations on a range of issues like Access to Medical Products, Quality of Pharmaceutical Starting Materials, Regulation of Advanced Therapy Medicinal Products and Replacing, Reducing and Refining dependence on animal studies, Improving Access to Medical Devices (including IVDs) Through Prequalification and Reliance and Prequalification of Medical Products etc. The African Medicines Agency provided update on the operationalisation of the AMA.

The main objective of the presentations was to discuss the impact of facilitated product introduction pathways on increasing access to medical products. They aimed to promote awareness of the dimensions and impact of issues related to the quality of pharmaceutical starting materials, sharing experiences, approaches, and interventions from regulators and other stakeholders, with a focus on high-risk starting materials. The presentations also sought to promote the establishment of robust regulatory frameworks for Advanced Therapy Medicinal Products, raise awareness and create opportunities for replacing, reducing, and refining reliance on animal studies, and provide information on the WHO prequalification of IVDs. Additionally, they explained the processes of reliance and recognition through prequalification and the Collaborative Registration Procedure (CRP), while addressing the successes and challenges of implementing reliance for IVD pre-market approval, and promoting the WHO Prequalification of Medicines (WHO PQT).

The presentations were followed by moderated panel discussions, Q&A sessions and finalization of recommendation/suggestions.

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MV

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