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2016年12月,美国、欧盟和日本共批准42个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。对全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。
In December 2016, the United States, the European Union and Japan approved a total of 42 new drugs, including new molecular entities, new active ingredients, new biological products, new indications and new dosage forms. Analysis of the first new molecular entities, new active ingredients, and new biological products approved in the world, highlighting the clinical findings and R & D history of these drugs.