New guideline on assessment and control of mutagenic impurities in veterinary medicinal products
In December 2018 the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a guideline on the assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products. The calculated threshold values are intended to ensure the safety of medicinal products for veterinary use not only for animals but also for the final consumers of animal products.
The document provides the framework for the categorisation, qualification and control of relevant mutagenic impurities. The aim is to limit the risk for cancer associated with the exposure to potentially mutagenic substances.
The drafting of the guideline was initiated in 2016 and the adopted version comprises changes to the original draft that were collected during the public consultation period in 2017. The guideline will become effective in 2020 to enable an adequate transition period for implementation.
In the first place the guideline applies to new marketing authorization applications but – under certain circumstances – may also affect already authorized medicinal products for veterinary use. It should be used complementary to the existing VICH guidelines GL10 and GL11. The guideline does not apply to biologicals/biotechnologicals, fermentation products, radiopharmaceuticals, excipients or products used for the treatment of oncologic indications, which may be genotoxic as a part of their mode of action.
The “Threshold of Toxicological Concern” (TTC) concept is used to characterize any risk associated with potentially genotoxic impurities in veterinary medicinal products, as it is also incorporated into several other regulatory frameworks (e.g. on human medicinal products, food products and animal feed). The derived threshold values are calculated to ensure safety of medicinal products for veterinary use for animals, but also for the final consumers of animal products.
The Austrian member of the Safety Working Party for veterinary medicinal products was the rapporteur for this guideline.
- Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products (EMA/CVMP/SWP/377245/2016) https://www.ema.europa.eu/documents/scientific-guideline/guideline-assessment-control-dna-reactive-mutagenic-impurities-veterinary-medicinal-products_en.pdf