Module 9 2021

19/03/2021

TSE Regulatory Guidance

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European Guidelines

a. WHO Guidelines on Transmissible Spongiform Encephalopathies in relation to b. Biological and Pharmaceutical Products Blood 2003 c. WHO Guidelines on TSE in relation to Biological and Pharmaceutical products (http://www.who.int/biologicals) d. EMEA/CPMP/BWP/476/01 (London, 28th February 2001): Public statement on the evaluation of Bovine Spongiform Encephalopathies (BSE)-risk via the use of materials of bovine origin in or during the manufacture of vaccines. e. EMEA/22314/02 (10th September 2002): Position Paper on Re-establishment of Working Seeds and Working Cell Banks using TSE compliant materials. f. CPMP/BWP/1793/02 (London, 18-June-2003). Note for guidance on the use of bovine serum in the manufacture of human biological medicinal products. g. Note for Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products- (EMEA/410/01 Rev 2) (2004/C 24/03) published in the Official Journal of the European Union and effective on 01-July-2004. h. Note for Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products- (EMEA/410/01 Rev 3) (2011/C 73/01) published in the Official Journal of the European Union and effective on 01-July-2011. i. OIE website at http://www.oie.int.

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TSE Regulatory Guidance

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USA (FDA) Guidelines/Letters

a. CBER Letter 3 May 1991: To Biologic Product Manufacturer ‘Pursuant to 21 CFR 207.31 that manufacturers of biologic products provide information regarding the source and control of bovine or ovine-derived materials’. b. FDA Letter 17 December 1993: To Manufacturers of FDA-regulated Products ‘bovine –derived materials from cattle which have resided in or originated from countries where BSE has been diagnosed not be used in the manufacture of FDA-regulated products. c. FDA Letter 9 May 1996: To Manufacturers of FDA-Regulated Drug/Biologic/Device Products ‘Strongly recommend to take whatever steps necessary to assure yourselves ….you are not using materials that have come from cattle born, raised or slaughtered in countries where BSE is known to exist. d. CBER Letter 19 Apr 2000: To Manufacturers of Biological Products: Recommendations Regarding Bovine Spongiform Encephalopathy (BSE). Refers to 1991, 1993 and 1996 letters and 1997 Guidance document reinforcing guidelines regarding use of ruminant materials. e. FDA (24 April 2001): Action Plan on Transmissible Spongiform Encephalopathies including BSE and Chronic Wasting Disease. f. Code of Federal Regulation 9CFR 113.53 - Requirements for ingredients of animal origin used for production of biologics. g. Japan Guidelines h. The Standard for Biological Ingredients (MHLW Notification No. 210 dated on 20- May-2003). Japanese Ministry of Health, Labor and Welfare (MHLW)

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