European Commission which issued a guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev.3) (2011/C 73/01) on July 1, 2011 has again revised the same.
This 3rd technical revision has been undertaken to take into account the advancement of science in the area of transmissible spongiform encephalopathies, as well as the evolving situation regarding Bovine Spongiform Encephalopathy (BSE) across the world.
It is identical with the EMA note for Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products - Revision 3 (EMA/410/01 rev. 3) which became official on July 1.
For the classification of countries or regions according to their BSE risk, the revised chapter will make reference to the rules laid down by the World Organization for Animal Health (OIE), replacing the previous GBR classification. Nevertheless, for countries that were classified according to the GBR criteria but not yet according to the OIE criteria, the existing GBR classification should apply, provided that there is no evidence of significant change in their BSE risk.
New criteria for the sourcing and processing of gelatin and bovine blood derivatives used in the manufacture of medicinal products for human or veterinary use have been introduced, as well as a new subsection on Peptones.
The revised Note for Guidance replaces the previous revision of the Note for Guidance (EMEA/410/01 Rev. 2) published in the Official Journal of the European Union (C 24, 28.1.2004, p. 6)) as the revised chapter replaces the last version, first published in the 5th edition.
TSEs are chronic degenerative nervous diseases characterized by the accumulation of an abnormal isoform of a cellular glycoprotein. The TSE diseases in animals include: Bovine Spongiform Encephalopathy (BSE) in cattle, crapie in sheep and goats, Chronic Wasting Disease (CWD) in cervids (deer and elk), Transmissible Mink Encephalopathy (TME) in farmed mink, Feline Spongiform Encephalopathy (FSE) in felids (specifically domestic cats and captive large cats), and spongiform encephalopathy of exotic ungulates in zoos.
In humans, spongiform encephalopathies include different forms of Creutzfeldt-Jakob Disease (CJD), Kuru, Gerstmann- Sträussler-Scheinker Syndrome (GSS), and Fatal Familial Insomnia (FFI).
To minimize the risk, manufacturers have a choice to use materials from ‘non TSE-relevant animal species’ or non-animal origin which are preferred. The rationale for using materials derived from ‘TSE- relevant animal species’ instead of materials from ‘non-TSE- relevant species’ or of non-animal origin should be given. If materials from ‘TSE-relevant animal species’ have to be used, consideration should be given to all the necessary measures to minimize the risk of transmission of TSE, stated the guidance.
According to Kaushik Desai, chairman, Industrial Pharmacy Division, Indian Pharmaceutical Association, the new guidelines reinstates EU’s stringent norms. The need to test content for animal spongiform encephalopathy agents is mandated for all excipients and active ingredients used in formulations.
The companies engaged in export of pharma excipients and active ingredients need to certify that the products are free from animal spongiform encephalopathy agents, added sources from Karnataka pharma.