EFPIA On How EU Can Become A ‘World Leader’ In Life Sciences
Report Draws On 60 Case Studies Of Regulatory Hurdles
More agile regulatory processes, a much shorter period for the European Commission to make new drug approval decisions, and a firm legal basis for the European Medicines Agency in assessing combination products. These are among proposals put forward by Europe’s R&D-based pharmaceutical industry amid moves to revise the EU medicines legislation.
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With proposals for an overhaul of the EU medicines legislation due at the end of this year, EFPIA has published its formal response to the European Commission’s consultation with suggestions for facilitating new antibiotic development, testing new regulatory approaches to novel medicines, and tackling medicine shortages.
From Innovation Mindsets To Incentives And COVID-19 Lessons: How EU Pharma Legislation Should Evolve
If the EU wants to become a more competitive space for innovation it can take a few lessons from both the US and the COVID-10 pandemic, say European pharma industry representatives. Fostering better communication between regulators and companies is just one example.
Challenges to the use of real-world data and the importance of wider international regulatory collaborations were among topics addressed by the European industry body EFPIA in a survey of its member companies.