Use of starting materials and intermediates collected from different sources in the manufacturing of non-recombinant biological medicinal products - Scientific guideline

This document clarifies the definition of starting materials for specific groups of biologicals. It presents CHMP's current position on the use of variant processes in early manufacturing stages of these products.

Keywords: Starting materials, sourcing, intermediates, heparins, urine derived products, plasma derived medicinal products, manufacturing process

Current effective version

Guideline on the use of starting materials and intermediates collected from different sources in the manufacturing of non-recombinant biological medicinal products

Adopted Reference Number: EMA/CHMP/BWP/729106/2011 Summary:

In 2007 the Co-ordination group for Mutual recognition and Decentralised procedures (CMDh) clarified the regulatory status as ”biological medicinal product” for a group of medicinal substances derived from biological sources such as heparins, gonadotrophins and urokinase.

Document history

Overview of comments received on 'Reflection paper on the use of starting materials and intermediates collected from different sources in the manufacturing of non-recombinant biological medicinal products'

Reference Number: EMA/CHMP/BWP/661511/2012

Reflection paper on the use of starting materials and intermediates collected from different sources in the manufacturing of biological medicinal products

Draft: consultation closed Consultation dates: 27/02/2012 to 31/08/2012 Reference Number: EMA/CHMP/BWP/729106/2011 Summary:

In the European pharmaceutical legislation, requirements are outlined for particulars and documents that should accompany an application for marketing authorisation of a biological medicinal product.