EMA

European Medicines Agency starts new review of cardiovascular risks of non-selective NSAIDs

The European Medicines Agency is reviewing the latest available data on the cardiovascular safety of non-selective NSAIDs (non-steroidal anti-inflammatory drugs). NSAIDS have been the subject of several European reviews in relation to gastrointestinal and cardiovascular safety and the occurrence of serious skin reactions. At the outcome of the last review on the cardiovascular safety of non-selective NSAIDs, in 2006, the Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the overall benefit-risk balance remained positive, but the possibility of a small increased risk of thrombotic events such as heart attacks or stroke with non-selective NSAIDs could not be excluded.

European Medicines Agency launches database of clinical studies in children completed before 2007

The European Medicines Agency has published a new database containing information on studies of medicines authorised in the European Union that were carried out in children and completed before the Paediatric Regulation came into force in 2007. The Article 45 paediatric studies database allows users to search for information on the studies’ names and aims, the medicines studied and the ages of patients included. For a subset of studies, documents summarising the study’s results are also available.

European Medicines Agency launches new database of European experts

Coinciding with the entry into force of new rules on how to handle conflicts of interests of scientific experts, the European Medicines Agency launched its new experts database. The database allows the public for the first time to directly search for the declarations of interests of all experts who have been nominated by competent authorities for medicines regulation across the European Union to be involved in the Agency's activities.

EU Clinical Trials Register recognised as 'primary registry' of WHO's International Clinical Trials Registry Platform

The World Health Organization (WHO) has recognised the European Union Clinical Trials Register (EU-CTR) as one of the primary registries for its International Clinical Trials Registry Platform (ICTRP). ICTRP is a web-based portal that allows access to a wide range of information from different clinical-trial registers from across the world. EU-CTR's recognition means that its information will be available through this portal by the end of the year, once the technical processes to allow transfer of the information are complete. It is also an endorsement of EU-CTR's importance for potential clinical-trial participants as well as sponsors, researchers, ethics committees and policymakers.

Concept paper on pharmacovigilance implementing measures released for consultation

The European Commission is seeking views from the public on a concept paper on implementing measures for the performance of activities related to the safety monitoring of medicines. The paper, which is open for consultation until 7 November 2011, provides technical details that the European Medicines Agency, medicines regulatory authorities in European Union (EU) Member States and marketing-authorisation holders will need to apply when implementing the new pharmacovigilance legislation.

New validation criteria for electronic submissions from 1 September 2011

The European Medicines Agency is informing pharmaceutical companies that a new version of the validation criteria for electronic applications for human medicines is coming into effect on Thursday 1 September. The Agency will be applying new electronic common technical document (eCTD) validation criteria (version 3.1) upon technical validation of all eCTD sequences received from this date. The Agency has agreed the new criteria with regulatory authorities in European Union (EU) Member States.

European Medicines Agency and its international partners complete successful inspection pilots

Two pilot programmes of collaboration on inspections between the European Medicines Agency (EMA) and its international partners in the United States and Australia have concluded successfully, according to two recently published reports. The two programmes focus on increasing international regulatory collaboration among the regulatory agencies so that drug quality and safety can be enhanced globally. The report on the joint good clinical practice (GCP) inspection pilot programme details the success of information-sharing and collaboration on inspections relating to clinical trials. Under the joint GCP inspection pilot, the EMA and the US Food and Drug Administration (FDA) exchanged more than 250 documents relating to 54 different medicines and, in conjunction with the GCP inspectors of the EU Member States, organised 13 collaborative inspections of clinical trials.

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