New Delhi [India], October 15 : The second day of the 19th International Conference of Drug Regulatory Authorities (ICDRA) workshop, held at the Yashobhoomi Convention Centre, Dwarka, New Delhi, concluded on Tuesday. The day featured several technical presentations and moderated panel discussions on the regulatory frameworks of various agencies worldwide, the Government of India said in a press release.
On Monday, Union Minister of Health & Family Welfare, Jagat Prakash Nadda, inaugurated the 19th ICDRA. The event, hosted for the first time in India from 14th to 18th 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 WHO member states.
The 19th ICDRA aims to facilitate focused discussions on quality issues, regulatory reforms, and the strengthening of regulatory systems, medical product safety, the detection, prevention, and response to substandard and falsified medical products, access to quality medical products, the regulation of clinical trials, regulatory collaboration, harmonisation, rationalisation, and reliance, as well as the regulation of new and novel technologies and herbal medicines.
During the workshop, co-moderators, speakers, and panellists from various countries, including Singapore, Switzerland, South Africa, Brazil, Uganda, Tanzania, the Netherlands, Canada, Zambia, Zimbabwe, Thailand, El Salvador, Nigeria, the USA, Ghana, Kenya, Botswana, Denmark, and India, delivered presentations on topics such as access to medical products, the quality of pharmaceutical starting materials, the regulation of advanced therapy medicinal products, reducing reliance on animal studies, and improving access to medical devices (including IVDs) through prequalification and reliance.
The African Medicines Agency also provided an update on the operationalisation of the AMA.
The primary objective of the presentations was to discuss the impact of facilitated product introduction pathways in increasing access to medical products. They aimed to raise awareness of issues related to the quality of pharmaceutical starting materials by sharing experiences, approaches, and interventions from regulators and other stakeholders, with a focus on high-risk starting materials.
The presentations also promoted the establishment of robust regulatory frameworks for advanced therapy medicinal products, advocated for reducing reliance on animal studies, and provided information on the WHO prequalification of IVDs. Furthermore, they discussed processes of reliance and recognition through prequalification and the Collaborative Registration Procedure (CRP), addressing both successes and challenges in 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 the finalisation of recommendations and suggestions.