On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
EDQM Publishes Draft Guidelines on Endotoxins, Pyrogens and Sterile Products
The revisions are intended to clarify the existing Guidelines and bring these in line with current knowledge. In particular, the following revisions have been introduced to the Guidelines:
• A new section has been included on bacterial endotoxins. The amplification includes issues to be considered when establishing an endotoxin limit for a specific substance or product;
• A recommendation that a monocyte-activation test or test for bacterial endotoxins is preferred to the rabbit pyrogen test. This revision is intended to avoid the use of live animals and reflects the European Convention for the Protection of Vertebrate Animals used for experimental and other scientific purposes;
• A recommendation that a risk assessment be performed when using the bacterial endotoxin test as a pyrogenicity test. This is due to the potential for contamination by non-endotoxin pyrogens.
The draft Guidelines have been published on EDQM's online publication, Pharmeuropa, and are available here. The draft revisions are open for comments from manufacturers, industry associations and other interested parties until 31 December 2014. Details on how to comment are available here.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017