EMEA/EC pharmaceutical news in brief

Published: 14-Aug-2009

The European Medicines Agency (EMEA) has recommended its first marketing authorisation for an advanced therapy medicinal product, ChondroCelect, developed by Belgium's TiGenix. It is a cell-based medicine, used to repair defects in the cartilage of the femoral condyle.


The European Medicines Agency (EMEA) has recommended its first marketing authorisation for an advanced therapy medicinal product, ChondroCelect, developed by Belgium's TiGenix. It is a cell-based medicine, used to repair defects in the cartilage of the femoral condyle.

It has also launched a Public consultation on a new transparency policy.

The agency has also released Guidance in EudraVigilance individual case safety report data quality checking and Advice for EudraVigilance testing by business partners .

EMEA has issued new Standard operating procedures for assessing active substances in centrally authorised products.

The agency has also released a Draft guideline on the clinical evaluation of antifungal agents .

Meanwhile, the European Commission has launched a Revised guidance for requesting authorisation of a medicinal product clinical trial ; and invites comments by 8 September.

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