PRIME movers: taking stock of the EMA's scheme
Views & Analysis
The European Medicines Agency’s PRIME scheme is becoming established as a way to hasten access to badly-needed medicines for serious diseases. Following its introduction in mid-2016, pharmaphorum’s Richard Staines takes stock of one of the agency’s flagship initiatives in the newly launched latest edition of Deep Dive: Market Access II.
Points covered in the article include:
- Scheme brings enhanced regulatory and scientific support to optimise innovative medicines addressing an unmet need.
- With PRIME, applicants are more confident that they are providing what is required, at the right time and the EMA gets better quality applications.
- Companies concentrating too much on the initial regulatory approval without planning the evidence needed for other stakeholders and post-authorisation development.
Read the full article here.
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