CDE retranslation of 85 foreign drug R & D technical guidelines

Source: Yigu 2017-08-04 Recently, the National Center for food and Drug Administration (CDE) issued a notice on reference to the technical guidelines for the research and development of foreign drugs (hereinafter referred to as the notice) The notice said that in order to deepen the reform of drug review and further promote the internationalization of technical standards for drug review, relevant units of CDE organizations continue to provide information to the World Health Organization (who) and the U.S Food and drug administration (FDA) and European drug regulatory agency (EMA) issued various technical guidelines for systematic collection, collation and translation, and published in the center's website "regulations and rules" - Translation of foreign guidelines "column It is understood that there are 85 guiding principles for this translation Last year, CDE organized the translation of 361 who, ICH and other drug R & D technical guidelines Such translated documents accelerate the convergence of China's and international drug R & D technical standards, help improve technical evaluation standards and serve drug R & D institutions.