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This guideline provides information on the safety aspects of veterinary biological medicines. Circular 3.0 H
This guideline supplements the guideline on oversight and monitoring of clinical trials to clarify and define the rules of investigators in investigational studies of medical products.
This document provides guidance on the procedures involved in the scheduling and conduct of pre—registration consultation meetings in respect of applications for biological medicines. It focuses on issues relating to the development of biological medicines in the planning phase of…
This guideline provides information to applicants wishing to submit data as evidence of efficacy for veterinary biological medicines
This guideline replaces the guideline on generic substitution published in 2003. It effectively cancels the list of not substitutable medicines. The only medicines declared to be not substitutable following this guideline of Biosimilars.
Related Tags (New Search): Biological medicines