EFPIA responds to EMA consultation on Regulatory Science Strategy

EFPIA has released its response to an EMA consultation, calling for support for innovation in clinical trials, improvement in regulatory advice provision, and promotion of real-world evidence use.

The European Medicines Agency (EMA) closed its EMA Regulatory Science Strategy to 2025 consultation at the end of June. It sought input on reform of its regulatory activities to better reflect the environment in which it operates. The EMA gave its goals as:

  • catalysing the integration of science and technology in medicine development
  • driving collaborative evidence generation –  improving the scientific quality of evaluations
  • advancing patient-centred access to medicines in partnership with healthcare systems (for human medicines only)
  • addressing emerging health threats
  • enabling and leveraging research and innovation in regulatory science

The European Federation of Pharmaceutical Industries and Associations (EFPIA) said:

“All five strategic goals within RSS 2025 address important priorities for the advancement of medicines and therapeutic care in Europe. In many cases, the recommendations set out by EMA are interrelated and interdependent. In practice, pursuing one recommendation may imply the need to progress others. Following EMA’s reflections from this consultation, industry anticipates the release of EMA’s 5-year implementation work plan, which will detail the Agency’s priority operations to action its regulatory science strategy.”

Read EFPIA’s response here.

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Published on 5. July 2019 in News, News EU