EMA

Countdown to launch of new EudraVigilance System

On 22 November 2017, the European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The new system will have enhanced features for the reporting and analysis of suspected adverse reactions to support a better safety monitoring of medicines and a more efficient reporting process for stakeholders.

EMA publishes comments on Member States' hosting bids

The European Medicines Agency (EMA) has published the information it submitted to the European Commission in support of its assessment of the 19 Member States' bids to host the Agency. This decision comes following the recent publication of isolated pieces of information circulating in the press in order to complete the picture and set the record straight.

How the EU regulates medicines

The European Medicines Agency (EMA) will host an awareness session to present the European Union’s (EU) medicines regulatory system and EMA's role in it to international regulators and non-governmental organisations. A clear understanding of how medicines are regulated in different parts of the word is of prime importance in an increasingly globalised world where regulators rely on close cooperation.

EMA launches survey to assess whether patients and doctors are aware of the arrangements for reporting of side effects

The European Medicines Agency (EMA) has launched a survey to better understand patients’ and healthcare professionals’ awareness of reporting adverse drug reactions, including for medicines under ‘additional monitoring’. Medicines under additional monitoring are monitored particularly closely by regulatory authorities.

EMA and EUnetHTA step up interaction to align data requirements

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) are stepping up their efforts to provide developers of medicines with simultaneous, coordinated advice on their development plans and facilitate alignment of data requirements. This initiative provides a single gateway for requests for parallel consultations with EMA and HTA bodies in the Member States on evidence-generation plans to support decision-making on marketing authorisation and health technology assessment.

Green light given for new EudraVigilance system for collection and monitoring of suspected adverse reactions

The European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The new version of EudraVigilance will go live on 22 November 2017 with enhanced functionalities for reporting and analysing suspected adverse reactions.

European and US regulators agree on mutual recognition of inspections of medicines manufacturers

Regulators in the European Union (EU) and the United States (US) have agreed to recognise inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic. Each year, national competent authorities from the EU and the US Food and Drug Administration (FDA) inspect many production sites of medicinal products in the EU, the US and elsewhere in the world, to ensure that these sites operate in compliance with good manufacturing practice (GMP).

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