EMA

EMEA and FDA launch Good Clinical Practice Initiative

The European Medicines Agency and the FDA have agreed to launch a joint initiative to collaborate on international Good Clinical Practice (GCP) inspection activities. This initiative comes under the scope of the confidentiality arrangements between the European Commission, the European Medicines Agency and the US FDA. The objectives of the initiative include the sharing of information on inspection planning, policy and outcomes and the conduct of collaborative inspections.

European Medicines Agency review of pandemic vaccines underway

The European Medicines Agency has started to receive data on H1N1 pandemic vaccines and the review began in July, with the commitment from the Committee for Medicinal Products for Human Use, to fast-track the review of data as vaccine manufacturers make them available. Given the public health threat posed by the current pandemic, the Agency's goal is to ensure data submitted to support marketing authorisations for vaccines are reviewed as early as possible, before the beginning of the Northern hemisphere flu season, expected in September.

European Medicines Agency update on safety of insulin glargine

Following review of all available information on a possible relationship between insulin analogues, in particular insulin glargine, and the risk of cancer, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the available data does not provide a cause for concern and that changes to the prescribing advice are therefore not necessary.

European Medicines Agency update on safety of insulin glargine

The European Medicines Agency (EMEA) is looking into four recently published registry studies investigating a possible relationship between insulin analogues, in particular insulin glargine, and the risk of cancer. The studies were published on the Diabetologia website on 26 June 2009.

European Medicines Agency recommends withdrawal of dextropropoxyphene-containing medicines

Finalising a review of the safety and efficacy of dextropropoxyphene-containing medicines, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that their risks, particularly the risk of potentially fatal overdose, are greater than their benefits. The Committee therefore recommended that the marketing authorisations for these medicines be withdrawn across the European Union.

European Medicines Agency launches public consultation on new transparency policy

The European Medicines Agency is inviting comments on its draft transparency policy until 25 September 2009. Since its inauguration in 1995, the Agency has worked continuously to improve the transparency of its operations, often extending the levels of transparency beyond the existing legal requirements. Bringing together all these initiatives, the new draft transparency policy describes for the first time in one comprehensive document the Agency's vision on its level of openness towards its stakeholders.

European public health agencies evaluate antibiotic resistance of Staphylococcus aureus

The European Food Safety Authority (EFSA), the European Centre for Disease Control and Prevention (ECDC) and the European Medicines Agency (EMEA) have published today a joint Scientific Report on meticillin resistant Staphylococcus aureus (MRSA) in livestock, pets and foods.

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