The European Medicines Agency (EMA) has recently released proposed changes to the pharmaceutical regulations in the European Union (EU), the first major review of these requirements since 2004.
The reform aims to adapt the legislation to the needs of the 21st century and achieve several key objectives that will benefit both the industry and the public. While the proposed changes will bring some positive developments, there are some important considerations that have not been fully addressed.
Creating a single market to deliver safe, effective and affordable medicines for all patients in the EU is a unique challenge.
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