Case Studies

Adaptation of IND to IMPD for submitting in EU countries

published 25 Mar 2021

Project based on:

US IND to be adapted and maintained as IMPD (Investigational Medicinal Product Dossier) for submission in EU countries as part of clinical trial application.

Company Description:

A US-based speciality pharmaceutical company. Its main areas of focus are ophthalmic and injectable preparations.

Support required/Problem statement:

To adapt the US-FDA approved IND (Investigational New Drug Application) for submission within the EU and to support preparation and submission of amendments subsequently.

Scope/added complexity:

  • Responsible for compiling the IMPD (Quality only IMPD) while taking into consideration significant interregional differences in content and format requirements.
  • The specific study population, nature of the product and duration of trial added to the complexity when compiling and amending the IMPD as Competent Authority questions referenced the safety risks associated with the potential presence of impurities in the IMP, requiring toxicological justification.
  • Due to the nature of the product, there were some stability issues and OOS results with respect to key parameters for some batches, which provided significant challenges resulting in amendments being made to the IMPD.
  • Changes to the process during development, changes to manufacturing lines and a change of Active Substance manufacturer also posed significant amendment challenges, while at the same time working with the supply team to ensure continuity of clinical trial supply.
  • Client-set target dates are invariably extremely challenging. Frequent ad hoc discussions with client have fostered a close working collaboration and team spirit, ensuring that all members of the team are well-coordinated and constantly aligned on the way forward.

Method:

All support is provided remotely.

Activities to date/Issues resolved:

  • Due diligence and gap analysis between the client’s US IND and EU IMPD requirements.
  • Providing technical guidance on resolution of gaps to ensure high speed of resolution while maintaining high quality and ensuring that the IMP remains suitable for use in all regions.
  • Co-ordinating with team responsible for submission of clinical trial application in multiple EU target markets.
  • Providing technical consultancy and strategic advice on responses to deficiency letters / requests for information received from Competent Authorities.
  • Assisting the client with classification of changes into substantial or non-substantial amendments and establishing the appropriate strategy for submission and for responding to requests for information from competent authorities.

Additional Information:

Reporting to: US-based Regulatory Affairs team.

Duration of contact: Activities commenced in February 2018 and work on amendments is still very active to date. Approvals have been obtained in all markets and RRL is supporting all regulatory activity involved with life cycle management of the IMPD.