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Christian Meyer and Gisela Grabow of Maiwald discuss potential changes to the EU pharmaceutical regulation and their potential impact on data and market protection timelines for medicinal products In ...

Blood Transfusion Association explains how the EU’s updated SoHO Regulation is impacting the sustainable and safe supply of ...

National legislation on the authorization of veterinary medicinal products and the prohibition of using hormones and ...

There is a pressing need for companies to transition their EU clinical ... details of their products used in clinicals trial are up to date in the extended EudraVigilance medicinal product ...

BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation regarding BioArctic's partner Eisai ...

Advanced Therapy Medicinal Products offers new opportunities in treatment and intervention for diseases but it is not without challenges.

The UK’s medicines regulator has published long-awaited guidance on regulation of medicines ... importing medicines and investigational medicinal products, pharmacovigilance procedures and ...

The Belgian Health Care Knowledge Centre and Sciensano, in collaboration with several Belgian institutions, have launched the ...

The EU Regulation on horizontal cybersecurity requirements for products with digital elements, the so-called Cyber Resilience Act, has been officially adopted on 10 October 2024 and will be ...

Aflibercept-Biosimilar FYB203 / AHZANTIVE®/ Baiama® receives positive CHMP Opinion from EMA ...

In the European Union (EU), OMPD is granted by the EC following a recommendation from the European Medicines Agency (EMA) via its Committee for Orphan Medicinal Products (COMP). OMPD status ...