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September 5, 2023
By now, most involved in the clinical trials disclosures field are aware of the upcoming reinstatement of the European Medicine Agency's (EMA) landmark transparency regulation: Policy 0070. Policy...
August 3, 2023
In a globalized pharmaceutical industry, ensuring the integrity and reliability of clinical data is of utmost importance. Recently, the Spanish Medicines Agency conducted a comprehensive Good...
April 13, 2023
Key messages from the mid-point achievements report To strengthen regulatory and scientific support for innovative medicines and diagnostics development, in March 2020 EMA published its Regulatory...
August 23, 2022
The European Medicines Agency (EMA) is supporting the European Union's (EU) response to the monkeypox outbreak. It is in close contact with medicine developers and its partner organisations in the EU...
August 22, 2022
Orphan Designation of ATMPs for Rare Diseases: MPS II Case Study Many advanced therapy medicinal products (ATMPs) in development in the EU are for rare diseases and conditions. Since the...
August 19, 2022
August 19, 2022 EMA’s Emergency Task Force (ETF) has reviewed data on the monkeypox vaccine Imvanex 1 used as an intradermal injection (given just below the top layer of the skin). The vaccine is...
August 10, 2022
The European Medicines Agency (EMA) provides support to medicine developers researching and developing potential COVID-19 medicines. Dedicated guidance, rapid procedures and contact points are...
August 8, 2022
Pharmaceutical companies should understand EU Health Technology Assessment (HTA) authorities requirements early in the product development phase. Engagement with HTA authorities during clinical...
August 3, 2022
August 2022 EMA Regulatory and Procedural Guideline Parallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing...