GDUFA II费用结构对仿制药变更的影响

beiwei5du

Impact of GDUFA II Fee Structure  on Generic Drug Change Evaluation
FDA在2018年 GDUFA II中取消了相应的prior-aproval supplment收费，这个也是促进企业不断提升工艺，改进质量的措施啊！（减少变更的经济负担），同时ICH Q12也可能快发布，以提供更加灵活的批准后变更的途径。
Conclusions  
When GDUFA II becomes effective on October 1, 2017, it will usher in a significantly revised fee
structure that is intended to simplify the generic drug submission and approval process  while
providing   a consistent source of revenue for the FDA. The upcoming fee structure changes will
include elimination   of fees for submission of Prior Approval Supplements (PAS ), which should
create a significant impact on the generic drug industry with respect to managing
manufacturing process changes.
With the elimination of a significant financial hurdle to post approval change, it  should   now be
more feasible for generic manufacturers to pursue enhancements to their drug products and
manufacturing processes.  M anufacturers may be encouraged to pursue quality enhancements
more proactively under GDUFA II.  The result can be a  greater shift from reactive to proactive
methodologies can benefit both the generics industry and the patient populations depending
on their medicinal products.

Prior Approval Supplement (PAS) Fees
Under GDUFA II, the  fee currently assessed for PAS submissions will be eliminated. This was
driven by the fact that the number of PAS’ filed each year was too unpredictable to allow FDA
to accurately forecast revenue from  fee collections. In addition, the agency recognized t hat
companies are sometimes required to file a PAS at the FDA’s request, which imposed an
unwarranted burden on  those application sponsors .

beiwei5du

同时减少CMO facility fee是在鼓励委托加工吗？？？

河西智叟

其实是药物经济学的一种表现吧，鼓励有能力的就是仿制药，压缩原研公司出了专利保护期的产品的利润空间。。。

小金库

非常感谢分享