1. Veterinary Vaccines / Biologicals in the EU Points of interest
NEW PRODUCT TYPES AUTHORISED:
CYTOPOINT:
First veterinary monoclonal antibody product in EU: 25th April 2017
Active: Caninised monoclonal antibody specifically targeting canine interleukin-31.
Indication: Treatment of clinical manifestations of atopic dermatitis in dogs.
CLYNAV:
First veterinary DNA vaccine in EU: 27th June 2017
Active: DNA plasmid coding for salmon alphavirus subtype 3.
Indication: Reduce impaired daily weight gain, mortality and cardiac, pancreatic and skeletal muscle lesions caused by pancreas disease in salmon due to SAV3 infection.
IWP GUIDELINES:
Published:
Requirements for the production and control of IVMPs (EMA/CVMP/IWP/206555/2010-Rev.1). Effective May 2017
New annex 2 on methods to demonstrate freedom from extraneous agents in IVMPs – replaces September 1994 Guideline 7BIm10a.
Under revision:
1996 Guideline on use of adjuvanted veterinary vaccines (EMA/CVMP/IWP/043/97).
Target date for public consultation of draft revision: Qtr
2001 Guideline: DNA vaccines non-amplifiable in eukaryotic cells for veterinary use EMA/CVMP/IWP/07/98
Target date for public consultation of draft revision: 2019
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ADVENT Q + A DOCUMENTS:
Specific questions on:
Allogenic mesenchymal stem cell-based products -
Tumorigenicity (EMA/CVMP/ADVENT/791465/2016) Effective 09th November 2017
Extraneous agents (EMA/CVMP/ADVENT/803494/2016)
Effective: 13th June 2017
Sterility
(EMA/CVMP/ADVENT/751229/2016)
Effective: 15th June 2017
Monoclonal antibodies for veterinary use: (EMA/CVMP/ADVENT/307606/2017
Effective: 07th December 2017
NOVEL PRODUCTS:
Stem Cell based products:  
Allogenic stem cell-based veterinary medicines originating from tissues (e.g. bone marrow or fat) from a donor from the same species of animal
Being developed mainly for treatment of joint inflammation / lameness in horses.
EU Network Training Centre – ASSESSOR TRAINING:
Harmonisation of assessment throughout the EU-
exchange of scientific and regulatory practices across the network.
October 2016: Safety and efficacy of IVMPs  (48 assessors)
October 2017: Quality assessment of IVMPs (54 assessors)
For further information contact
nationalstemcellcenters.com
bio.udel.edu