The first episode of our video series features Dr Laurie Smaldone Alsup, former CSO and CMO, currently SVP of Regulatory Science at NDA engaged in a thoughtful dialogue with regulatory pioneer Dr Thomas Lönngren regarding opportunities and developments in European healthcare regulation. Dr Lönngren, having served as Executive Director of the EMA for 10 years during which reforms in orphan drugs, paediatrics and pharmacovigilance legislation took place, was able to provide valuable insights into regulatory changes in Europe.

The conversation between these two regulatory titans revolved around the upcoming changes to the European regulatory framework. In the near future, two new legislative initiatives will impact pharmaceutical companies.

At the Regulatory Horizon

A new Health Technology Assessment Regulation is taking effect in 2025. This process will require oncology and advanced therapy products to undergo a joint scientific assessment after receiving approval from the European Medicines Agency. The goal of this assessment is to guide reimbursement decisions across European member states.

The experts emphasized that companies working in oncology and advanced therapies need to understand the full scope of this new Health Technology Assessment process, including the mandated review and joint assessment of these products at a European level after regulatory approval.

Dr Lönngren also highlighted one of the more significant proposed changes to the Pharmaceutical Legislation, which is the European Commission's initiative to lower the number of years for market exclusivity protection for orphan drugs. The goal of this proposal is to address the current issues around availability and access to new medicines across European Union member states.

Dr Lönngren advised companies to carefully evaluate how such shortened exclusivity timeframes may impact the anticipated return on their investment and regulatory status of products in development, as this proposal seeks to strengthen post-approval availability at the potential expense of longer market protections.

Actions for Biotech Companies

To effectively plan for these upcoming regulatory changes in Europe, biotech companies should take the following actions:

  • Closely monitor proposed changes and understand implications for regulatory pathways and business strategies.
  • Non-EU biotech companies can leverage regulatory expertise like NDA's to navigate the evolving landscape effectively.
  • Oncology/orphan drug developers must plan for the 2025 joint assessment mechanism and factor in the exclusivity changes that are currently under consideration.


In his conversation with Dr Laurie Smaldone Alsup, Dr Thomas Lönngren provided insightful perspectives on upcoming regulatory changes in Europe based on his extensive experience at the European Medicines Agency. Two major new areas were identified and Dr. Lönngren advised smaller biotech companies to closely track these evolving EU regulations and leverage experts. Understanding the new legislative environment will be important for effectively planning their development and commercialization strategies for the lucrative EU market in the future.

If you need assistance in navigating these changes or have questions about their impact on your business, consider reaching out to regulatory experts like NDA. Your proactive approach to understanding and responding to these developments will be key to your success in the dynamic EU market.

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