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On April 1, 2025, the European Medicines Agency opened the consultation period for its draft reflection paper on a tailored clinical approach in biosimilar development....more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be...more
On 28 April 2017, the European Commission (the EC) published a “roadmap” on the strategic approach to pharmaceuticals in the environment, particularly in the aquatic environment. Concurrently, the EC launched a 12-week...more