免费医药信息获取的途径与经验.docx

1. Food and Drug Administration ()1.1. News EventsHome→News EventsFDA发布的信息不局限于新药，增加适应症、重磅首仿也会出新闻稿，个别不重要新药的新药获批不会有新闻稿。新闻稿篇幅较短，概括力很强，提炼出核心临床数据、主要副作用，另外还会提到该适应症的其他药物。1.2. New Drug Approvals1.2.1. NME ApprovalsHome→Drug→Navigate the Drugs Section→Development Approval Process (Drugs)→Drug Innovation1.2.2. Biological ApprovalsHome→Vaccines, Blood Biologics→Navigate the Vaccines, Blood Biologics Section→Development Approval Process (Biologics)→Biological Approvals by Year1.2.3. Drug Approval Reports by MonthHome→Approvals Clearances→Drug Approval Reports by Month月报里面NDA是新药，BLA是生物制品，ANDA是仿制药，Approval Type是Efficacy Supplement with Clinical Data to Support时，可能涉及到增加适应症。1.3. GuidancesHome→Drug→Navigate the Drugs Section→Guidance, Compliance Regulatory Information →Guidances (Drugs)1.4. Drug Information (Labels, Therapeutic Equivalents)Home→Drug→Spotlight→Drug Information (Drugs@FDA)→Search→这是查询药品处方信息的标准途径，也是查询已失效?Label文件的唯一途径。1.5. Patent and Exclusivity InformationHome→Drug→Spotlight→Orange Book Search→Search→Drug Substance Claim栏下为Y的表示涉及化合物专利，一般Patent Expiration最早的就是最核心的专利，但这里面涉及到美国独特的专利延期制度，Orange Book的主要用途是查到美国专利，然后根据美国专利确定中国同族专利（方法见第7部分）。Orange Book还有个Exclusivity Expiration时间，这里是行政保护到期时间（类似于中国的新药监测期），行政保护一般与专利保护是并行的。1.6. FDA的几个特殊通道Fast Track：FDA在临床阶段介入，提供指导意见，帮助企业少走弯路，滚动递交申报材料。Accelerated Approval：以临床替代终点审批上市，比如用反映肿瘤萎缩的应答率代替生存期。Priority Review：审批时间由标准的10个月缩减为6个月。Breakthrough Therapy：加强版的Fast Track，申请需提供有效性证据。Qualified Infectious Disease Product：抗菌药才能获得，额外叠加5年行政保护期。Orphan Drug：罕见病药物，提供7年行政保护期及减税。Special Protocol Assessment：III期临床前可以签SPA，保证III期试验方案满足FDA的要求。Priority Review Voucher：达成FDA的条件可以获得优先审评券，市价在7000万美元/张。?2. European Medicines Agency (www.ema.europa.eu)2.1. News EventsHome→News Events2.2. New Drug ApprovalsHome→New Medicines2.3. GuidancesHome→Human Regulatory→Scientific guidelines?3. Pharmaceuticals and Medical Devices Agency (www.pmda.go.jp)3.1. New Drug ApprovalsHome→Services of PMDA→Drug and Medical Device Reviews→ Approved Products→List of Approved Product