EMA consultation: Guidelines on the requirements for quality documentation concerning medicinal products in clinical trials

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The European Medicines Agency has published for public consultation the two guidelines below, which are to be seen in connection with Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, which came into force on June 20, 2014.

Since clinical trials will often be designed as multi-centre studies, potentially involving different Member States, it is the aim of these guidelines to define harmonised requirements for the documentation to be submitted throughout the European Union.

This guideline addresses the documentation on the chemical and pharmaceutical quality of IMPs and Auxiliary Medicinal Products containing chemically defined drug substances, synthetic peptides, synthetic oligonucleotides, herbal substances, herbal preparations and chemically defined radio-active/radio-labelled substances to be submitted to the competent authority for approval prior to beginning a clinical trial in humans. It includes the requirements for IMPs and Auxiliary Medicinal Products to be tested in phase I, phase II, phase III and phase IV studies as well as the requirements for modified and unmodified comparator products and IMPs to be tested in generic bioequivalence studies.

Comments should be provided using this template and sent to QWP@ema.europa.eu by 31 August 2021.

For more information please click here.

This guideline addresses the specific documentation requirements on the biological, chemical and pharmaceutical quality of IMPs containing biological/biotechnology derived substances.

It also lists, as regards documentation on the biological, chemical and pharmaceutical quality of the IMP, examples of modifications which are typically considered as ‘substantial’.  

The guidance outlined in this document applies to proteins and polypeptides, their derivatives, and products of which they are components (e.g. conjugates). These proteins and polypeptides are produced from recombinant or non-recombinant cell-culture expression systems and can be highly purified and characterised using an appropriate set of analytical procedures. The guideline also applies to Auxiliary Medicinal Products containing these proteins and polypeptides as active substances. The requirements depend on the type of the product (authorised/not authorised/modified/non-modified medicinal product).  

The principles may also apply to other product types such as proteins and polypeptides isolated from tissues and body fluids.  

Advanced Therapy Medicinal Products are excluded from this guideline.

Comments should be provided using this template and sent to BWPsecretariat@ema.europa.eu by 31 August 2021.

For more information please click here.

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For more information on the European regulatory system for medicines, please click here (brochure available in all languages).

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