Zdrowie i gospodarka · 06/02/2002
International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on “Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms” (VICH GL30); Request for Comments; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (#143) entitled "Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms" (VICH GL30). This draft guidance has been developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance addresses the process for developing a controlled list of terms in order to assure that terms are used consistently in adverse event reports, and to allow comparison between products and across product classes. This draft guidance is limited to developing a controlled list of terms describing veterinary medicinal products (VMPs), animals, clinical signs, and associated body systems and organs for reporting an adverse event associated with the use of a VMP.