Guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals)
ثبت نشده
چکیده
منابع مشابه
Better regulation of veterinary pharmaceuticals: how to put in place a simpler legal framework, safeguarding public and animal
"The Commission is aware of concerns expressed by citizens, veterinarians, Member States and the animal health industry as regards the directive laying down the rules for the authorization of veterinary medicinal products, in particular the importance of addressing existing problems linked to the availability of veterinary medicinal products and the use of medicinal products in species for whic...
متن کاملCell-Based Veterinary Pharmaceuticals – Basic Legal Parameters Set by the Veterinary Pharmaceutical Law and the Genetic Engineering Law of the European Union
Cell-based therapies have been in use in veterinary medicine for years. However, the legal requirement of manufacturing, placing on the market and use of cell-based veterinary pharmaceuticals are not as well developed as the respective requirements of chemical pharmaceuticals. Cell-based veterinary pharmaceuticals are medicinal products in the sense of the pharmaceutical law of the European Uni...
متن کاملMedicinal plants for gingivitis: a review of clinical trials
Objective(s): Periodontal diseases are among prevalent oral health problems which may ultimately lead to severe complications in oral cavity. Herbal products can be designed as single or multicomponent preparations for better oral health. This study aims to review current clinical trials on the effectiveness of herbal products in gingivitis. Materials and Methods: Electronic databases, includin...
متن کاملGuideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches
An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. 15 December 2016 EMA/CHMP/CVMP/JEG-3Rs/450091/2012 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veter...
متن کاملDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Medicinal Products – Quality, Safety and Efficacy
Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal ...
متن کامل