Reliance into Action : Understanding EMA Documents to Streamline Reliance for Marketing Authorization Applications

Abstract According to data gathered from across EU pharmaceutical trade associations, the European Medicines Agency (EMA) is one of the most frequently selected reference regulatory authority (RRA) for reliance procedures due its transparency, detailed decision-making reflected on its public assessment reports and easy access to information related to the assessment of medicines. This review discusses the implementation of unilateral reliance pathways for marketing authorization applications (MAAs) based on EMA assessment. The EMA established a focus group dedicated to reliance in 2022, with the primary aim of understanding the opportunities and hurdles encountered by European industry when using the EMA as RRA in global regulatory filings. A survey conducted among industry stakeholders revealed significant benefits of reliance pathways, including reduced approval timelines and decreased inquiries from relying authorities. However, the survey also highlighted persistent hurdles that hinder the benefits of unilateral reliance pathway, such as variability in documentation requirements and a lack of consistency across the documents requested by each national regulatory authority (NRA) when relying on EMA assessment. The findings highlight the need for collaboration between regulatory authorities and industry to streamline reliance processes and data requirements to make informed reliance decisions ultimately improving global access to safe, effective, and quality-assured medical products.