文档介绍：中美仿制药研发申报流程
10. Statistical
11. Case Report Tabulations
12. Case Report Forms
13. Patent Information
14. Patent Cd to reduce drug abuse) (in development)
505(b)(2)新药的例子
New Active Ingredient
Pexeva (paroxetine mesylate) (new salt) (2003)
New Route of Administration
Emezine (prochlorperazine) (new buccal/transmucosal delivery) (NDA pending)
Oral amphotericin-B (pre-clinical)
RxOTC Switch
Alavert (loratadine) (2002)
505(b)(2)新药的例子
“Generic Biologics”
Omnitrope (rHGH) (2006)
Glucagen (glucagon recombinant) (1998)
Hyaluronidase (various approvals 2004-05)
Fortical (calcitonin salmon recombinant) (2005)
* Examples based on publicly available information
FDA NDA 审评过程
FDA 可以使用已有数据用于审评NDA吗？
Hatch-Waxman之前,国会限制 FDA在审评 NDA X时应用 NDA Y的数据：“No data in an NDA can be utilized to support another NDA without express permission of the original NDA holder.”[FDA “Finkel Memorandum” (1978, 1981)]
Hatch-Waxman 解除只适合 ANDAs：ANDA process allows “generic producer of the fully tested drug to rely on the safety and efficacy data of a prior applicant . . . .”
505(b)(2) does not authorize such data reliance
Merely sets conditions for certain NDAs
Requires “full reports of investigations” establishing safety and effectiveness [21 USC §§ 355(b)(1)(A), (d)(1)]
美国仿制药
A generic drug product is one that is comparable to an innovator drug product ( also known as the reference listed drug (RLD) product as identified in the FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations) in dosage form, strength, route of administration, quality, performance characteristics and intended use.
Generic drug applications are termed “abbreviated” in that they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.
These parameters were established upon the approval of the innovator drug product, which is the first version of the drug product approved by the FDA.
FDA审评仿制药程序
二、美国仿制药的申报、审评和研发对策
由FDA的OGD