Why pharma teams are drowning in submissions and what to do about it – Part one

Regulatory affairs (RA) teams are under pressure more than ever before. Faced with a growing demand for pharmaceuticals, cumulative legislative changes and an approaching steep patent cliff, sponsors are struggling to find new ways to modernize, innovate and deliver therapeutics to market faster.   The greatest challenge isn’t just the volume of work, but the unpredictable complexity of a global regulatory landscape. Unlike demographic shifts such as the doubling of the world’s population aged 60 and above by 2050, or the $350 billion worldwide revenue loss that the industry will support through 2030 due to loss of exclusivity (LoE), regulatory change is a moving target, influenced by public health policies, technological progress and political agenda.  Legal and regulatory changes: growing pressure on the pharma industry  Looking ahead, the FDA and EMA will continue to push for modernization, introducing new frameworks and guidance around digitized submissions and AI.