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The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising…
Access to patient data gathered in clinical trials is a highly controversial and complex issue that needs to balance three aspects: the public right to transparency regarding data used to approve new medicines, protection of the data privacy rights…
The global population is ageing, but inequalities remain in older people's access to treatment, especially people 75 years of age and older. These people receive less frequent interventions and lower quality medical treatment than their younger…
A risk management plan (RMP) is a complex regulatory document which is now required in the European Union as part of a medicine's approval process. This article offers practical guidance for medical writers who are interested in writing an RMP. In a…
The articles included in this section are a selection from the European Medicines Agency’s News and Press Release archive for August 2016 – Oct 2016. More information can be found on the Agency’s website: www.ema.europa.eu of medicines to treat…
The articles included in this section are a selection from the European Medicines Agency’s news and press release archive for November 2015 to March 2016.
The articles included in this section are a selection from the European Medicines Agency’s news and press release archive for April 2016 to July 2016.
The articles included in this section are a selection from the European Medicines Agency (EMA)’s News and Press Releases archive. More information can be found on the Agency’s website: www.ema.europa.eu.
The articles included in this section are a selection from the European Medicines Agency’s News and Press Release archive from July 2018 to September 2018. More information can be found on the agency’s website: www.ema.europa.eu
The articles included in this section are a selection from the European Medicines Agency (EMA)’s News and Press Releases archive from July 2019 to September 2019. More information can be found on the Agency’s website: www.ema.europa.eu.
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