EMA releases new guideline on stability testing

Published: 23-Apr-2014
Regulatory

While allowing for flexibility to encompass a variety of practical situations


Guidance on stability testing during applications for variations to an existing marketing authorisation has been released by the European Medicines Agency (EMA). It states what stability data should generally be required, while allowing for 'sufficient flexibility to encompass the variety of different practical situations' regarding the science and material under evaluation.

For instance, the new guidance says if the quality characteristics of an active substance are changed so that stability may be compromised, comparative stability data is recommended. For active substances considered unstable, six months data on at least three batches of a pilot-scale batch size are needed and three months for active substances known to be stable.

EMA’s advice also says what stability testing data is required when a company changes its manufacturing site or process for a medicine, or adjusts its immediate packaging.

'The stability data outlined in this guideline reflects the usual expectation of the regulators,' said a comment within the guidance.

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