ICH E6 GCP Guideline: Updated GMP for IMP Principles

The ICH Management Committee has published a draft version of the updated principles that are currently under development by the ICH E6(R3) Expert Working Group (EWG). According to the ICH, the ICH E6 Good Clinical Practice (GCP) Guideline principles are "interdependent and should be considered in their totality to assure ethical trial conduct, participant safety, and reliable results of clinical trials". However, at this stage, the EWG is not taking public comments on the principles. Once the ICH E6(R3) Guideline reaches Step 2/3 of the ICH guideline development process, the EWG will invite and consider public input.

Impact on GMP for IMPs

The current principles of the ICH GCP Guideline (ICH E6 (R2)) relating to GMP for Investigational Medicinal Products, IMPs, include the following:

  • IMPs should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.

With the third revision of ICH E6 (ICH E6(R3)), these GMP for IMP principles are expected to be expanded to the following:

IMPs used in a clinical trial should be manufactured in accordance with applicable GMP standards and be stored, shipped, and handled in accordance with the product specifications and the trial protocol. In particular the following applies:

  • IMPs should be manufactured under GMP.
  • Measures should be in place to ensure that the IMP provided to trial participants retains its quality.
  • IMPs should be used in accordance with the protocol and relevant study documents.
  • Manufacturing, handling, and labelling of IMPs should be undertaken in a manner that maintains blinding, and treatment assignment, where applicable.
  • IMP labelling should follow the appropriate regulatory requirements.
  • Risk-based approaches should be considered when implementing proportionate measures to ensure GMP and the appropriate shipping and handling of the IMP.

Previously, the WHO already published two new draft documents relating to Development and GMP for IMPs: "Good Practices for Research and Development Facilities" and "GMP for IMPs".

The Draft Principles of ICH E6 GCP can be found on the ICH Guideline page. For additional information on the ICH E6 revision, please see the Reflection Paper on Renovation of Good Clinical Practice and the Concept Paper. Other materials, including the current guideline, ICH E6(R2): Guideline for Good Clinical Practice, the business plan, work plan, an expert list, and reports of prior public engagements are available on the ICH website - Efficacy Guidelines.

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