On 25 April 2014, the European Medicines Agency (“EMA”) published a Draft Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission (“Draft Guideline”). The Draft Guideline is open for consultation until 31 October 2014.
This Draft Guideline provides guidance on the process validation of biotechnology-derived proteins used as active substances in the manufacture of medicinal products. The Draft Guideline also determines the validation data to be submitted as part of an application for marketing authorisation or variation of an existing authorisation for a medicinal product.
The Draft Guideline applies to recombinant proteins and polypeptides, their derivatives, and products of which they are components (for example, conjugates) and other biological products such as vaccines or blood products, as appropriate. In addition, the Draft Guideline advises pharmaceutical companies to consult with the appropriate competent authorities to determine if the provisions of the Draft Guideline are applicable to the company’s biological product.
Pharmaceutical companies interested in submitting comments on the Draft Guideline may submit their comments to BWPSecretariat@ema.europa.eu using the template which is referenced in the Draft Guideline.