New EMEA Guideline Draft on Stability Testing with Modified Testing Conditions

 
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 here.

Author
Dr. Gerhard Becker
On behalf of the European Compliance Academy (ECA)