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EMA

 •  December 1

EMA and European Commission publish updated Q&AsThe European Medicines Agency (EMA) and the European Commission have published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s withdrawal from the European Union (EU).Companies are reminded to plan in advance for the situation that the United Kingdom (UK) will...

EMA

 •  December 1

SummaryThis meeting will aim to define the opportunities and challenges in applying a common data model in Europe to support regulatory decision-making and agree guiding principles for the development of such a model, including key criteria for validation in the context of regulatory decision-making. A common data model could help harmonise...

EMA

 •  December 1

Title Committee for Advanced Therapies (CAT): 6-8 December 2017 Date 06/12/2017 - 08/12/2017 Location European Medicines Agency, London, UK Summary The Committee for Advanced Therapies (CAT) is the committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines.

EMA

 •  November 28

Additional guidance relates to medicines for human and veterinary useThe European Medicines Agency (EMA) has published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU).The guidance document outlines the practical and simplified requirements that companies should...

EMA

 •  November 24

Adaptations ensure a high level of quality for ATMPs and patient protectionThe European Commission has published a set of guidelines on good manufacturing practice (GMP) specific to advanced therapy medicinal products (ATMPs).ATMPs are medicines for human use that are based on genes or cells. These therapies offer ground-breaking new opportunities...

EMA

 •  November 22

Better safety monitoring for patients across EuropeThe European Medicines Agency (EMA) has launched today 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 makes it...

EMA

 •  November 7

Close collaboration with new host country as of day one key for successful moveWith less than two weeks to go before EU Member States select a new host city for the European Medicines Agency (EMA) on 20 November 2017, the Agency prepares itself to immediately start working with the new host country. As of that date, the Agency has less than 17...

EMA

 •  November 1

SummaryPrior knowledge has always been an important tool in designing both manufacturing processes and control strategies for medicinal products. The use of prior knowledge in regulatory application dossiers, to support manufacturing and control strategies, could be justifiable in certain circumstances. For prior knowledge to be used in this way,...

EMA

 •  October 31

Major milestone is a testimony to mutual trust1 November 2017 marks the coming into operation of further aspects of the mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories. This agreement, which updates...

EMA

 •  October 27

Studies show low adherence to restrictions aimed at reducing risks of kidney injury and deathThe European Medicines Agency (EMA) has started a new review of medicines containing hydroxyethyl-starch (HES). These products are used for the management of hypovolaemia (low blood volume) caused by acute (sudden) blood loss, where treatment with...