Significant Guidelines regarding Veterinary Medicinal Products

On 20 December 2011, the EMA published significant guidelines for manufacturers of medicinal products for veterinary use: some of them as final documents, others as drafts for comments.

From a quality aspect, the guideline on statistical evaluation of stability data (Draft VICH GL51: Quality: statistical evaluation of stability data) is particularly interesting.

This guideline presents Step 4 in the VICH procedure (VICH = International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products). The VICH Guideline "GL(3) Stability Testing of New Veterinary Drug Substances and Medicinal Products" describes essential requirements regarding stability testing of veterinary medicinal products.

In this new guideline, extrapolation - i.e. the extension of the retest period or the shelf life of a veterinary medicinal products beyond the investigated period at ambient temperature - is explicitly permitted, particularly if no significant change is observed at the accelerated condition. 

The guideline also presents the different statistical approaches which may be used. In Annex A, you can find a decision tree how to proceed.

By the way, the content of this guideline is identical to the corresponding ICH/ (EMA) Guideline Q1E "Evaluation for Stability Data" for Medicinal Products for Human Use.

In addition, further documents have been published for veterinary medicinal products:

  • Draft VICH GL50: Biologicals: testing harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use
  • Scientific guideline: Reflection paper on testing strategy and risk assessment for plants, adopted
  • Draft guideline on risk characterisation and assessment of maximum residue limits (MRLs) for biocides 
  • Draft VICH GL34: Biologicals: testing for the detection of Mycoplasma contamination

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