Improving Flexibility By Omitting Expiry Dates

Post date: Oct 16, 2011 9:34:32 AM

This talk was presented by Evelyn Edwards (Clinical Supplies & IVRS Consultant) at the 9th Annual Informa Life Sciences Clinical Trials Supplies and Packaging Conference in Basel (10-11 October 2011)

The accompanying slides summarise the current discussions regarding the omission of expiry dates from Investigational Product (IP) for use in clinical trials. There is and always will be mixed reaction and uptake of the existing Directive 2003/94/EC which allows the exclusion of certain pieces of information where “its absence can be justified, e.g. use of a centralised electronic randomisation system”.

The ISPE (International Society for Pharmaceutical Engineering) and PDA (Parenteral Drug Association) White Paper: Use of Interactive Voice Response or Web Systems to Manage IMP Retest Dates (17-November-2009 Version 6.1), began the conversation. A survey was carried out by the team of 11 ISPE/PDA representatives and a summary of the results is included in the slides. The comfort levels of the various stakeholders were discussed with industry being the most supportive of IVRS managing expiry dates with unique medication/kit ID numbers possibly because of their understanding of and familiarity with the IVRS functions.

The European Medicines Agency has released a ‘Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials which focusses on the omission of expiry dates from IP. The presentation summarised the key points of each section of the EMA paper which discusses circumstances when it is or is not appropriate to omit expiry dates from labels and the expectations of sponsors, vendors and the IVR/IWR system. A link to the document and other relevant sites is included in the slides.

The consultation period has begun and closes on 15 February 2012. In view of “The potential for the revision of Annex 13” being considered in line with this EMA document I urge all to review and think about the impact on your sector of industry. Please register your approval or make comment on the paper in a timely manner.