New EMA Draft Guideline on Stability Data regarding Applications for Variations to a Marketing Authorisation

On 27 July 2011, the EMA published a revision of the "Guideline on stability testing for applications for variations to a marketing authorisation" dating from 2005.

This guideline addresses the requirements in terms of stability testing data which drug manufacturers have to provide when applying variations to a marketing authorisation. Due to the extensive changes in the new Variations Regulation EC 1234/2008 from 1st January 2010, the revision of the guideline was necessary.

Type IB variations have been added to the Variations Regulation as a new standard category. A new paragraph on the requirements on stability data for IB variations has therefore been amended. In accordance with EC 1234/2008, the draft contains many differentiated regulations regarding stability testing for type II variations. These regulations concern stability data which are necessary when submitting following variations:

  • Introduction of a new API manufacturer supported by an Active Substance Master File (ASMF)
  • Change in the manufacturer of starting materials, reagent or intermediate
  • Change to an API manufacturer who uses an alternative route of synthesis or different manufacturing conditions, which may change important quality characteristics such as impurity profile or physico-chemical properties of the API and its bioavailability
  • Change in coating weight of oral dosage forms
  • Change in immediate packaging of the API
  • Change in the manufacturing process and in the batch size of the finished product

Furthermore, the draft guideline requires the performance of follow-up stability studies on commitment batches for all type IA variations (as long as stability data must be generated for the change in question).

Please see the new draft guideline as well as the currently valid guideline for comparison. 


During the conference "Setting Specifications - Stability Testing

" from 5 - 7 October 2011 in Frankfurt, you will receive current information regarding the topic stability data in case of variations.

Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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