Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials

On 1 July 2021 the EMA published the draft guideline, revision 2.

This guidance addresses the specific documentation requirements on the biological, chemical and pharmaceutical quality of investigational medicinal product (IMP) containing biological/biotechnology derived substances. It applies to cases where no 'simplified IMP Dossier' is submitted.

Please note that requirements related to the Clinical Trial Regulation will apply only on entry into application of the Regulation. Scientific requirements apply from 26 April 2018.

Since clinical trials can be designed as multi-center studies potentially involving different Member States, it is the aim of this guideline to define harmonised requirements for the documentation to be submitted throughout the European Union.

Most available guidelines on the quality of biological / biotechnological medicinal products address quality requirements for marketing authorisation applications. Whilst these guidelines may not be fully applicable in the context of a clinical trial application, the principles outlined are applicable and should be taken into consideration during product development. The guidelines on Virus safety evaluation of biotechnological investigational medicinal products (EMEA/CHMP/BWP/398498/05) and Strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products (EMEA/CHMP/SWP/28367/07) should also be consulted.

In the context of an overall development strategy, several clinical trials, using products from different versions of the manufacturing process, may be initiated to generate data to support a Marketing Authorisation Application. The objective of this document is to address the quality requirements of an investigational medicinal product for a given clinical trial and not to provide guidance on a Company's overall development strategy for a medicinal product.

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