EU regulators combine efforts on cell-based and gene therapy products

Published: 18-Nov-2013

EMA and EDQM stage a joint symposium on the difficulty of securing information about the quality of raw materials

The European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines and HealthCare (EDQM) have joined forces to promote quality standards for manufacturing cell-based and gene therapy pharmaceuticals. The two bodies have staged a joint symposium on the difficulty of securing suitable information about the quality of raw materials, increasing the difficulty of assessing their impact on medicine quality and safety.

Topics discussed included what quality attributes are important for raw materials, and relations between manufacturers and users.

Participants also debated what raw materials should be included in the European Pharmacopoeia, which tries to harmonise medicine laws for the 47 member countries of the Council of Europe, which is independent of the European Union (EU) and includes non-EU states, such as Russia.

The meeting also looked at how raw materials should be grouped in regulations. There was agreement that 'the current lack of harmonisation in the quality standards for raw materials represented a challenge,' said the EDQM.

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