IMPD - extension of shelf-life - substantial amendment?

Dear Colleagues,

it seems that some EU countries are now asking for a substantial amendment for shelf-life extension even if the IMPD includes under “P.8 Stability” the proposed text explaining the non-substantial shelf-life extension plan.

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Could you please confirm if you experience the same?

See example of IMPD text that is added to not require notification of a substantial amendment as long as the following criteria are met:

  1. All stability data must meet applicable specifications (Section P.5.1) for tests in the
    stability protocol for long-term storage conditions.
  2. An evaluation of long-term stability data show all test parameters remaining within
    applicable specifications upon extension to a new shelf life.
  3. Stability data for GMP lots drug product are currently being generated at long-term storage conditions and at accelerated storage conditions. These clinical lots will continue to be monitored throughout the course of the clinical study.
  4. Dating extensions based on available real time data and acceptable accelerated data will
    not exceed 12 months plus the available real time data.

Thanks in advance for your feedback.

Wish you All a great day !

Kind regards,

Gabriel

Hi Gabriel,
Thank you for raising this. This is not an issue I have come across recently where future extension of shelf-life is proposed. In addition to the points you have listed (which seem reasonable), do you also include a stability protocol listing future timepoints to be included for stability testing? In my experience, if this has been provided (per following IMPD guidance) along with conditions for extrapolation based on those at the end of these guidance documents, then it has been accepted without questions.

Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials (europa.eu)

Guideline on the requirements for the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (europa.eu)

Kind Regards,
Steve

Hi Steve,

thanks very much for your reply. Finally, it turned out that the issue identified could be challenged and we are still being able to not submit substantial amendments for future shelf life extension as long as of course the IMPD describes well this situation.

This discussion will help I hope anyone interested on how to avoid substantial amendments when increasing the shelf-life of the drug product during a clinical study run in EU.

Wish you a great day !

Gabriel