EMA Guideline for Stability Testing for Applications for Variations in revision

The new Variations Regulation together with the two "supporting Guidelines" on the different variation types ("classification guideline") and on the procedure when submitting variations ("procedural guideline") has been in effect since the beginning of this year. In consequence, all guidelines associated with variations for an existing authorisation must promptly be aligned to avoid regulatory gaps or inconsistencies.

EMA is taking the first step with the "Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation" (CPMP/QWP/576/96 Rev 1; EMEA/CVMP/373/04), which has been in effect since 1 December 2005. This guideline still refers to the previous, now repealed Regulations EC 1084/2003 and 1085/2003. It only describes the variation types IA, IB and II and is now to be adapted accordingly. In charge is the Joint CHMP/CVMP Quality Working Party.

EMA announced the revision on March 3rd with a draft paper on the need for revision of the document and subsequently opened the annotation period. Comments or change requests to be considered in the revise of the guideline may be submitted to the EMA until 30 April 2010.

The draft paper can be found here here which will also take you to the Guideline to be revised and to a template for submitting comments to the EMA.

Dr. Gerhard Becker
On behalf of ECA

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