首页 > 资讯 > 美卫生部加强审查FDA对仿制药生产商的检查

出自识林

2014-11-13 HHS

近日美国卫生与公共服务部（HHS）监察长办公室（OIG，负责审查卫生与公共服务部下属各机构的部门）发布2015财年工作计划。工作计划概述了OIG计划在当前财年及今后实施的与HHS项目和业务有关的新的和正在进行的审查和活动。工作计划描述了主要目标，同时各审查内容后附有内部识别码和预期发布年份，预计将有更多的审查报告作为审查结果发布。审查报告发布时，将公布在OIG的网站，OIG的电子邮件订阅者也会自动收到提醒。

工作计划中指出，本财年将对FDA监管的5个领域实施审查，包括，仿制药生产商检查、已批准药品上市后研究监督、高风险食品设施检查、药品供应链信息交换审评、药品申请人临床研究报告要求合规性。

有关FDA仿制药生产商检查的内容翻译如下：
“我们将确定FDA对仿制药生产商实施检查的范围。我们也将陈述这类检查的结果，以及针对不足或缺陷FDA所采取的强制行动。FDA通常会在仿制药批准之前检查药品生产设施，以及对国内外生产商开展日常检查以监测GMP的符合性。仿制药是FDA批准的品牌药的仿制品，必须与原品牌药关于使用条件、活性成分、给药途径、剂型、规格、标签和表观特征相同。制药企业在营销和制造新的仿制药之前必须获得FDA批准。（OEI:01-13-00600；预期发布日期：2015财年）”

工作计划中对FDA下5个领域的审查内容原文如下，请查看。

• FDA—Inspection of generic drug manufacturers

We will determine the extent to which FDA conducts inspections of generic drug manufacturers. We will also describe the results of such inspections and the enforcement actions taken by FDA in response to shortcomings or deficiencies. FDA typically inspects drug manufacturing facilities before generic drug approval and conducts routine inspections of foreign and domestic manufacturers to monitor compliance with good manufacturing practices. Generic drugs are copies of FDA-approved brand-name drugs that must be equivalent to the original drugs with respect to conditions of use, active ingredient(s), route of administration, dosage form, strength, labeling, and performance characteristics. Pharmaceutical companies must receive FDA approval before marketing and manufacturing a new generic drug. (OEI; 01-13-00600; expected issue date: FY 2015)

• FDA—Oversight of postmarketing studies of approved drugs

We will determine the extent to which FDA requires postmarketing studies and clinical trials (referred to as postmarketing requirements, or PMRs) for new drug applications. We will also assess how FDA monitors PMRs and takes enforcement action against applicants that do not comply with them. Section 505(o)(3) of the Food and Drug Administration Amendments Act of 2007 (FDAAA) provides FDA new authority to require additional testing of an approved prescription drug or biological product to assess serious risk related to its use. Under this authority, FDA may require an applicant to conduct PMRs at the time of approval or after approval if FDA becomes aware of new safety information or an unexpected serious risk associated with the use of the drug. (OEI; 01-13- 00390; expected issue date: FY 2015)

• FDA—Review of information exchange in the drug supply chain

We will review drug supply chain trading partners' (e.g., drug manufacturers, wholesale distributors, dispensers) early experiences in exchanging transaction information and transaction history as required by section 202 of the Drug Supply Chain Security Act. Transaction information includes basic information about the drug (e.g., the strength and dosage form of the product, the National Drug Code, etc.), and the transaction history includes transaction information for every prior transaction for that drug back to the manufacturer. Together, this information forms the foundation of drug traceability and the security of the drug supply chain. Except for dispensers, trading partners must comply with the new exchange requirements by January 1, 2015, (dispensers have until July 1, 2015, to comply). We will interview trading partners about how they have successfully exchanged this information and what, if any, obstacles they have faced. (OEI; 05-14-00640; expected issue date: FY 2015)

• FDA—Drug sponsors' compliance with clinical trial reporting requirements

In 2007, Congress passed the FDAAA (42 U.S.C. § 282(j)) which mandated that certain clinical trials be registered and their results be reported in the clinical trial registry and reporting data bank known as ClinicalTrials.gov. These reporting requirements are an important tool that enhances FDA' s ability to assess and monitor a drug's safety and efficacy. We will determine the extent to which clinical trials comply with the reporting requirements set forth by the FDAAA and the way in which FDA is ensuring that these requirements are met. (OEI; 02-14-00610; expected issue date: FY 2015)

编译：识林-椒 2014-11-13

识林www.shilinx.com版权所有，未经许可不得转载。如需使用请联系zhzhao@shilinx.com