Reliance and Worksharing Procedures: Industry and Regulator Perspectives

Regulatory reliance and worksharing pathways are important tools that help accelerate access to medicines by enabling regulatory agencies to collaborate or leverage the work of other trusted agencies. In doing so, regulatory authorities can streamline the approval process for medicines with a reduction in duplication of effort allowing resource to effectively prioritised, expediting access to safe and effective treatments. Industry benefits from these approaches that offer greater certainty in assessment timelines and harmonised outcomes.

This session will focus on perspectives from industry and regulators on some of the reliance and worksharing routes, together with examples of European Medicines Agency (EMA) and US Food and Drug Administration (FDA) collaboration, including:

- Cluster activities involving EMA, FDA and other global regulators, which are areas of cooperation focusing on special topics and therapeutic areas identified as requiring an intensified exchange of information and collaboration – examples of which include ATMPs, biosimilars, oncology and paediatrics.

- Parallel Scientific Advice and Protocol Assistance between EMA and FDA, which aims to increase dialogue between the two agencies and sponsors during medicinal product development, leading to a deeper understanding of the bases of regulatory decisions, avoidance of unnecessary testing replication or unnecessary diverse testing methodologies and overall optimisation of product development.

- Access Consortium, which facilitates collaborative assessment of medicine applications, including New Active Substances (NAS), Generics, and Biosimilars by a coalition of regulators including Health Canada, Swissmedic, the Australian Therapeutic Goods Administration (TGA), Health Sciences Authority of Singapore and the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK.

- UK’s International Reliance Procedure, which enables MHRA to take into account the regulatory outcome from another trusted regulatory agency and make a targeted assessment of an application. Regulators include the US FDA, Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, Health Canada, Swissmedic, the Australian Therapeutic Goods Administration (TGA) and Health Sciences Authority of Singapore.