Requirements for quality documentation concerning biological investigational medicinal products in clinical trials
|Current effective version|
|Reference number||EMA/CHMP/BWP/534898/2008 Rev. 1|
|Keywords||Biological product, investigational medicinal product (IMP), clinical trial, quality|
This document 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 enty into application of the Regulation. Scientific requirements apply from 26 April 2018.
In operation: 15/04/2012-26/04/2018
- Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials
- Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial
- ICH Q5C Stability testing of biotechnological/biological products
- ICH Q5D Derivation and characterisation of cell substrates used for production of biotechnological/biological products
- Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products
- Plasma-derived medicinal products
- Process validation for finished products – information and data to be provided in regulatory submissions
- Strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products
- Virus safety evaluation of biotechnological investigational medicinal products