Regulacje i polityka gospodarcza · 16/12/2002

Draft Guideline on Testing for the Detection of Mycoplasma Contamination

A draft guideline titled "Testing for the Detection of Mycoplasma Contamination" has been developed by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The draft guideline provides procedures for the testing of some veterinary biologics to detect mycoplasma contamination. Since the draft guideline applies to veterinary biological products regulated by the Animal and Plant Health Inspection Service under the Virus-Serum-Toxin Act, we are requesting comments on its provisions so that we may include any relevant public input on the draft in the Agency's comments to the VICH Steering Committee.