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Published: 1-Dec-2003


The European Agency for the Evaluation of Medicinal Products (EMEA) earmarked €3.3m for fee reductions regarding market approval applications for orphan drugs this year. It also streamlined the fee exemption application process, sending out receipts that signalled approval of a lower charge rather than a time consuming formal notification.

Studies into the nutritional impact of zinc in food supplements and its use in anti-ageing drugs are being funded by a new €166m tranche of the EU's sixth framework programme for research. The Commission said no focused research has been conducted in this area. Zinc deficiency can cause frailty, general disability, cancer and atherosclerosis.

EMEA and the US FDA have launched their first parallel scientific advice procedure since September's signing of a confidentiality agreement regarding such co-operation. This first pilot exchange of views follows a request from an unnamed pharmaceutical manufacturer for guidance on approving orphan medicinal products.

The European Commission has ordered that €170m be released at once from the European Development Fund to be spent on the fight against malaria, tuberculosis and HIV/AIDS. The money had originally been earmarked for spending over a four-year period (2003-2006).

EMEA has warned of a high rate of virologic failures in HIV patients treated with once-daily triple nucleosides/nucleotides reverse transcriptase inhibitor combinations containing didanosine, lamivudine and tenofovir. EMEA's scientific committee has asked the marketing authorisation holder to investigate.

  

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