News

Approval of combined Advanced Therapy Product

With a press release dated from 26 April, the European Medicines Agency (EMA) announced the CAT and Committee for Medicinal Products for Human Use (CHMP) recommendation for approval of a combined advanced-therapy product. Read more.

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Risk-based Approach to Advanced Therapy Medicinal Products

In 2012, the EMA Draft guideline on the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products was open for comments. The risk-based approach is based on the identification of various risks associated with the clinical use of an ATMP and risk factors inherent to the ATMP with respect to quality, safety and efficacy. To learn more about this, click here.

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EMA announces streamlining of activities of Committee for Advanced Therapies

To optimise the efficiency of EMA and the Committee for Advanced Therapies' in the field of ATMP, EMA has streamlined the activities of the CAT. More details here.

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Commitee for Advanced Therapy Medicinal Products (CAT) - Public Call for Expression of Interest

For membership in the Committee for Advanced Therapy Medicinal Products (CAT), the European Commisiion published a public call for interested representatives of patients' associates and clinicians. Read more here.

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ATMP - EMA Reflection Paper on Classification of Advanced Therapy Medicinal Products

Recently, the European Medicines Agency published an Reflection Paper on classification of advanced therapy medicinal products. This document is open for consultation until 31 July 2012. Read on.

 

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EMA Position Statement on Creutzfeldt-Jakob Disease and advanced Therapy medicinal Products

In June 2011, the CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products was agreed to by the Biologics Working Party and adopted by the CHMP/CAT. Read more here.

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