International Conference on Harmonisation of Technical Requirements: International Conference on Harmonisation of Technical Requirements for ... New Zealand Therapeutic Products Authority - Couverture souple

 
9786130242978: International Conference on Harmonisation of Technical Requirements: International Conference on Harmonisation of Technical Requirements for ... New Zealand Therapeutic Products Authority

Synopsis

Please note that the content of this book primarily consists of articles available from Wikipedia or other free sources online. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration.Harmonisation would lead to a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety, and efficacy, and regulatory obligations to protect public health.ICH guidelines have been adopted as law in several countries, but are only used as guidance for the U.S. Food and Drug Administration.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Présentation de l'éditeur

Please note that the content of this book primarily consists of articles available from Wikipedia or other free sources online. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration.Harmonisation would lead to a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety, and efficacy, and regulatory obligations to protect public health.ICH guidelines have been adopted as law in several countries, but are only used as guidance for the U.S. Food and Drug Administration.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.