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Animal Health News Archive

2015

April 2015

The European Medicines Agency’s (EMA) Committee for Medicinal Products For Veterinary Use (CVMP) and VICH Scientiic Guideline Updates

VICH Updates
  • GL24, Pharmacovigilance, Pharmacovigilance of veterinary medicinal products: management of Adverse Event Reports (AERs). Implementation date December 2015.
  • GL30, Pharmacovigilance: list of terms, Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms. Implementation date December 2015
  • GL35, Pharmacovigilance: ESTD, Pharmacovigilance: Electronic Standards for Transfer of Data. Implementation date December 2015
  • GL42, Pharmacovigilance: Data elements, Pharmacovigilance: Data Elements for Submission of Adverse Events Reports. Implementation date December 2015
  • GL23, Safety: Genotoxicity, Studies to evaluate the safety of residues of veterinary drug in human food: genotoxicity testing. Implementation date October 2015.

EMA CVMP Updates 

Safety and Residues of Pharmaceuticals, Toxicology
– VICH GL23(R): Studies to evaluate the safety of residues of veterinary drugs in human food: Genotoxicity testing Adopted guideline CVMP/VICH/526/2000, Effective date October 2015
Safety and Residues of Pharmaceuticals, Antimicrobials
– Risk of antimicrobial resistance transfer from companion animals, Reflection paper, EMA/CVMP/AWP/401740/2013, Overview of comments published January 2015
Safety and Residues of Pharmaceuticals, Biocides for use in animal husbandry
– Risk characterisation and assessment of Maximum Residue Limits (MRL) for biocides Overview of comments Adopted guideline EMA/CVMP/90250/2010 Effective date 1st August 2015
Efficacy Pharmaceuticals
– Demonstration of palatability of veterinary medicinal products Overview of comments, Adopted guideline CVMP/EWP/206024/2011, Effective date 1st February 2015
Immunologicals: General
– Use of heat treatment to inactivate retrovirus RD114 in live immunological veterinary medicinal products (IVMPs) Reflection paper EMA/CVMP/IWP/37924/2014, end of consultation was 31st March 2015
– Replacement of cell lines used for the production of immunological veterinary medicinal products (IVMPs) Reflection paper EMA/CVMP/IWP/37620/2014, end of consultation was 31st Mach 2015
– Guideline on the compliance of authorised equine influenza vaccines with OIE requirements Overview of comments Adopted guideline EMA/CVMP/IWP/97961/2013, effective date May 2015
– The procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus Draft guideline EMA/CVMP/IWP/205351/2006 Rev. 1, end of consultation 30th April 2015.

2014

April 2014 - Update of Veterinary Pharmaceuticals EMA Scientific Guidance

QUALITY

Non-immunologicals - Stability
VICH GL51: Quality: Statistical evaluation of stability data, Adopted guideline Ref. EMA/CVMP/VICH/858875/2011
Effective date 28 February 2014

SAFETY & RESIDUES

Pharmaceuticals - Residues and Withdrawal Periods
Injection-site residues: Considerations for risk assessment and residue surveillance. Release for consultation Draft reflection paper Ref. EMA/CVMP/520190/2007 Rev. 1
Deadline for comments 30 April 2014

EFFICACY GUIDELINES

General
VICH GL52 on Bioequivalence: blood level bioequivalence study. Draft guidance EMA/CVMP/VICH/751935/2013 Release for consultation. End of consultation 31 May 2014

Specific Guidance
Conduct of efficacy studies for non-steroidal anti-inflamatory drugs (NSAIDs) Adopted guideline Ref. CVMP/EWP/1061/2001. Effective from August 2014.

Products for intramammary use
Conduct of efficacy studies for intramammary products for use in cattle Draft guideline Ref. CVMP/EWP/141272/2011
Deadline for comments 30 April 2014

IMMUNOLOGICALS

General
VICH GL50: Biologicals: Testing harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use Adopted guideline Ref. EMA/CVMP/VICH/582610/2009.
Effective from March 2014

Requirements for combined vaccines and associations of immonological veterinary medicinal products (IVMPs) Adopted guideline Ref. EMA/CVMP/IWP/594618/2010
Effective from February 2014

VICH GL34: Biologicals: Testing for the detection of mycoplasma contamination Adopted guideline Ref. EMA/CVMP/VICH/463/2002
Effective from 28 February 2014.

2013

EMA Guidelines

QUALITY

API: Active Substance Master File Procedure, Adopted Guideline # CVMP/134/02 Rev. 3, and effective date Oct 2012
Non-Immunologicals: Setting Specifications for Related Impurities in Antibiotics, Adopted guidelines # CHMP/CVMP/ QWP/199250/09, and effective date June 2013

Post approval change management protocols

Questions and answers on post approval change management protocols Adopted guideline # EMA/CHMP/CVMP/QWP/586330/2010, implementation date October 2012.

SAFETY AND RESIDUES

Pharmaceuticals: Assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicine, Draft guideline, # EMA/CVMP/ERA/52740/2012, and deadline for comments 1 February 2013.

EFFICACY

Pharmaceuticals: Demonstration of palatability of veterinary medicinal products, Draft guideline, # CVMP/EWP/206024/20110, and end of consultation 13th May 2013 Conduct of efficacy studies for NSAIDs (EMEA/CVMP/237/01), Draft guideline’ #EMA/CVMP/EWP/1061/2001, and deadline for comments 31st May 2013.

Testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats Concept paper, #EMA/CVMP/EWP/290691/2012, and end of consultation January 2013.

IMMUNOLOGICALS

General: Table of extraneous agents to be tested for in relation to the Guideline on requirements for the production and control of immunological veterinary medicinal products, Draft guideline, # EMA/CVMP/IWP/105112/2011, and end of consultation 31st May 2013

Requirements for the production and control of immunological veterinary medicinal products, Adopted guideline, # EMA/CVMP/IWP/206555/2010, and implementation date 1st January 2013.

VICH Guidelines

Safety: General approach to testing microbiological ADI VICH GL36, Studies to evaluate the safety of residues of veterinary drugs in human food: General Approach to establish a microbiological ADI and implementation date June 2013.

2012

Animals in Scientific procedures: Govenment response to public consultation on European Directive 2010/63/EU on the protection of animals used for scientific purposes

The government intend to copy most of the provisions of the directive into UK law as they stand, however ministers have highlighted a number of areas where stricter standards will apply, including:

  • The retention of 'special protection' for dogs, cats and horses, as well as non-human primates
  • Provision for higher levels of care and accommodation for animals in cases where the annex to the directive specifies lower standards than current UK provision

The response and the accompanying Written Ministerial Statement can be accessed through the Home Office website here

European Medicines Agency - Veterinary Medicines Scientific Guidelines Update

Quality

Impurities
VICH GL18: Residual solvents in new veterinary medicinal products , active substances and excipients, Adopted Guidelines Ref, CVMP?VICH/502/99-Rev.1, effective date July 2012.

Stability
VICH GL51: Quality: statistical evaluation of styability data, Draft guideline. Ref, EMA/CVMP/VICH/858875/2011, end of consultation 12 June 2012.

Manufacture of medicinal products
Process validation, Draft guidance. Ref EMA/CHMP/CVMP/QWP/99738/2012, deadline for comments 31 October 2012.

Safety and Residues

Environmental Risk Assessment
Testing strategy and risk assessment for plants, Adopted reflection paper. Ref, EMA/CVMP/ERA/147844/2011, effective date 1 June 2012.

Establishment of Maximum Residue Limits
Assessment of Pharmacological/Pharmacodynamic data to establish a Pharmacological ADI Draft guideline. Ref, CVMP/SWP/355689/2006, end of consultation 31 July 2012. 

Biocides
Risk characterisation and assessment of Maximum Residue Limits (MRL) for biocides draft guideline. Ref, EMA/CVMP/90250/2010. end of consultation 30 June 2012.

Efficacy

General
Revision: Statistical principles for veterinary clinical trials Adopted guideline. Ref, CVMP/EWP/81976/2010, effective date, 1 August 2012. 

Immunologicals

General
VICH GL50: Biologicals: testing harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use, draft guideline. Ref, CVMP/VICH/582610/2009, end of consultation 12 June 2012.

VICH Guidelines
GL18, Impurities; Residual Solvents, 'Impurities:Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients', quality guideline, implementation date June 2012.

European Medicines Agency

Overview of comments received on the CVMP reflection paper on risk management plans for centrally authorised veterinary medicinal products (EMEA/CVMP/126726/2007)

Click here

Concept paper introducing a review and update to existing EU guidelines on residue studies to bring these into line with the International Cooperation on Harmonisation of Technical Requirements for Registratyion of Veterinary Medicinal Products metabolism and residue guidelines GL46 to 49

Click here

EMA Consultation: Medicial Products for Veterinary Use

Draft VICH GL34: Biologicals: testing for the detection of mycoplasma contamination. The document is available for consultation by clicking here. Please note that the deadline for comments for this draft guideline is 12 March 2012.

Draft VICH GL50: Biologicals: testing harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use. The document is available for consultation by clicking here. Please note that the deadline for comments for the draft document is 12 June 2012.

Draft VICH GL51: Quality: statistical evaluation of stability data. The document is available for consultation by clicking here. Please note that the deadline for comments for this draft guideline is 12 June 2012.

Draft guideline on risk characterisation and assessment of maximum residue limits (MRLs) for biocides.
This document is available for consultation by clicking here. Please note that the deadline for comments for this draft guideline is 30 June 2012.

Comments relating to these draft guidelines should be provided using the link to the template in the draft guidance document. The completed comments form should be sent to vet-guidelines@ema.europe.eu.