药物研发至2016中国和印度原料药生产商欺诈和主要GMP违规.docxVIP

20160302 ECA新闻：中国和印度原料药生产商欺诈和主要GMP违规??GMP News02/03/2016Fraud and Major GMP Violations at API Manufacturers in India and China中国和印度原料药生产商欺诈和主要GMP违规The Non-Compliance reports in the?Eudra-GMDP database of the European Medicines Agency (EMA)are - to a certain extent - the European counterpart of FDAs Warning Letters. These reports are first drawn up then put in the database after a GMP inspection performed by a representative of the European?national competent?authorities at an API or medicinal product manufacturer showed serious GMP deficiencies. Similar to Warning Letters, the consequences of