Re: TSE BSE Guidelines
As you want to get Transmissible Spongiform Encephalopathy (TSE) Guidelines for Minimising the Risk of Contamination in Chinese Proprietary Medicines, Traditional Medicines & Health Supplements, so here I am providing it for your reference:
Transmissible Spongiform Encephalopathy (TSE) includes scrapie in sheep and goats, chronic wasting disease in mule, deer and elk, bovine spongiform encephalopathy (BSE) in cattle, as well as Kuru and Creutzfeldt-Jakob Disease (CJD) in humans.
BSE was first recognised in the United Kingdom in 1986
A large number of cattle and individual herds have since been affected. BSE is a food borne infection.
The discovery of vCJD has raised concerns that the BSE agent can be transmitted to man.
This guideline provides recommendations that should be followed to minimise the risk of TSE agent contamination in Chinese Proprietary Medicines,
Assessment report for the risk of TSE
The supporting documents should include an assessment report on the risk of TSE in relation to the product when required by the Authority.
Certificate of Suitability
Where applicable, Certificates of Suitability for some animal-derived materials could be obtained from the European Directorate for the Quality of Medicines (EDQM).
Compliance with Legal Requirements
The responsibility is on companies dealing in these products to ensure that their products comply with the relevant legal requirements.
Documented and recorded source of animals
Maximum therapeutic dosage
Intended use of the products
Nature of animal tissue used in the manufacture
Quantity of tissue used in these products
Route of administration
Here I am attaching a file that has complete details about Guidelines:
Answered By StudyChaCha Member
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