The challenges addressed by the reform are fundamental. Medicines authorized for marketing in the EU still do not reach patients fast enough and are not equally available in all member states. There are significant gaps in response to unmet medical needs, rare diseases and antimicrobial resistance. High prices for innovative treatments and drug shortages remain a major concern for patients and health systems. In addition, for the EU to remain an attractive investment destination and a global leader in drug development, it must adapt its regulations to the digital transformation and new technologies, while cutting red tape and simplifying procedures. In addition, new regulations must take into account the environmental impact of drug production in line with the goals of the European Green Deal.
The review includes proposals for a new directive and a new regulation that amend and replace existing pharmaceutical legislation, including regulations on medicines for children and medicines for rare diseases. It aims to achieve the following main objectives:
- Creating a single market for medicines to ensure that all patients across the EU have quick and equal access to safe, effective and affordable medicines;
- Continue to offer an attractive and innovation-friendly framework for drug research, development and manufacturing in Europe;
- Dramatically reduce the administrative burden by significantly speeding up procedures, reducing the time it takes to issue marketing authorizations for drugs so that they reach patients more quickly;
- Incr...
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