EMA to draft new guidance on assessing chemistry of active substances

Published: 19-Mar-2014
Regulatory

Will replace older guidelines approved in 2003 and 1987


New European Union (EU) guidance will be produced for EU pharmaceutical companies on assessing the chemistry of active substances.

The European Medicines Agency (EMA) is planning to release a draft by June. It will replace two older guidelines – approved in 2003 and 1987 – and it will take account of changes to related EU regulations, directives and guidance.

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