Biotech Values

[elmono]

I found a link to a new EMEA guideline regarding biotech-derived proteins, that especifically deals with quality issues. Hypothetically, since we are talking about a recombinant product here, GTCB has to deal with all the issues described in this document and the EMEA wants to already put this guideline into full practice. Personally I found the requirements described in the document pretty intimidating

Could it just be that the main reason for the additional questions that the EMEA is planning on asking, might have to do with intensified regulations? Or are my thoughts very much 'off track'.

This is the link:

http://www.emea.eu.int/pdfs/human/bwp/4934805en.pdf

elmono

The document's title is:

GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE: QUALITY ISSUES

Happy to hear comments from the specialists regarding this document