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EMA

 •  September 12

Awareness session for international regulators and NGOs on the work of EMA and European medicines regulatory systemThe 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...

EMA

 •  September 6

The CVMP will be holding an interested parties meeting as part of regular stakeholder liaison. Topics for discussion this year will include antimicrobials resistance (AMR), persistent, bioaccumulative and toxic (PBT) assessments, quality guidelines on veterinary medicines, the Pilot Project on the Harmonisation and Optimisation of Veterinary...

EMA

 •  September 5

SummaryThis joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include discussions on the work plans for 2018/19; a proposal for revision of PCWP/HCPWP mandates and rules of procedure; a proposal for streamlining the process for re-assessment of eligibility status, compassionate use...

EMA

 •  September 1

EMA implements new submission form for post-authorisation measuresThe European Medicines Agency (EMA) has launched a new form to help marketing authorisation holders submit data generated to satisfy post-authorisation measures (PAMs) for centrally authorised products.PAMs require marketing authorisation holders (MAHs) to provide additional data on...

EMA

 •  September 1

Title Committee for Advanced Therapies (CAT): 6-8 September 2017 Date 06/09/2017 - 08/09/2017 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

 •  August 24

EMA closed from 18:30 on Friday 25 August until 7:30 on Tuesday 29 August 2017Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +44 (0)20 3660 7600. Please note that this is an emergency number and should only be used in the event of a potentially serious problem with a centrally authorised...

EMA

 •  August 23

New commitment allows FDA to share full inspection reports with European Commission and EMAThe European Commission (EC), the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential...

EMA

 •  August 16

Brief interruption expected from 07:00-08:00 (UK time) on Thursday 17 August due to essential maintenanceThe European Medicines Agency (EMA) website will be briefly unavailable from 07:00-08:00 (UK time) on 17 August due to essential maintenance. During this time, a holding page will display EMA contact details, including the emergency number for...

EMA

 •  August 8

East African Community (EAC) envisages the creation of regional regulatory entityAs part of the European Medicines Agency's (EMA) ongoing collaboration with African regulators, a delegation of Heads of Agencies from the East African Community (EAC) visited EMA to gather information on the structure and operations of EMA. The meeting that took place...

EMA

 •  August 1

Business continuity plan aims to preserve Agency’s ability to protect public and animal healthThe European Medicines Agency (EMA) has developed and initiated a business continuity plan to deal with the uncertainty and workload implications linked to the United Kingdom’s (UK’s) withdrawal from the European Union (EU) and the Agency’s...