On 11 October the European Medicines Agency (EMEA) issued the new guideline
draft Guideline on Stability Testing: Stability Testing of existing active
substances and related finished products for consultation (end of the
commenting period will be 30 April 2008). This guideline will replace the still
valid Note for Guidance with the same title. The revision of the note was
necessary to adapt it to the stability guideline for veterinary drugs
(Stability Testing of new Veterinary drug substances and medicinal products),
which will become effective in January 2008.
The new guideline essentially comprises the following
requirements for investigating stability data for active substances and finished
products relative to the marketing authorisation:
The guideline also explicitly applies to herbal drugs and preparations; the
version valid so far did not include them.
In addition to long term (25°C) and accelerated (40°C)
testing, intermediate conditions will now also be mandatory i.e. testing
conditions in the middle temperature ranges at 30°C and 65% RH (exception:
substances and drugs that need to be stored in refrigerators or freezers).
Long term studies can be conducted for a 6-month period
either at 25°C/60% RH or at 30°C/65% RH. In the latter case it is not
necessary to provide data at 30°C/65% RH beyond the 6-month period.
For long term studies 6-months-data can already be
stated in the authorisation dossier.
Overall the new guideline draft is a lot more differentiated
regarding testing conditions for the various substance types and drug forms. The
decision tree at the end of the document is a good help for managing the
complexity of the various requirements. It offers an orientation for the
estimation of half-lives or retest periods.
The EMEA draft guideline is available
Stability testing of substances and finished products are a
central issue at the ECA conference Setting Specifications and Stability
Testing in Vienna, Austria, from 2628 November 2007.
Experienced speakers from authorities and the industry will provide
practical tips relative to stability testing within the authorisation
Dr. Gerhard Becker
On behalf of the European Compliance Academy (ECA)