ANDA申请的中国研发.pdfVIP

ANDA ANDA • ANDA • ANDA— • ANDA • (QbD) -- ANDA ANDA • ANDA—Abbreviated New Drug Application: • ANDA20013001000 • DMF20013001000 • • FDA • • DMF • 7 3/ • (QbD) • To begin with the end in mind FDA FDA • • This success, however, also has come to represent a significant regulatory challenge, and delays in approvals of generic drugs have emerged as a major concern for the generics industry, FDA, consumers, and payers alike. Unlike the brand manufacturers who pay fees under PDUFA, the generic industry does not pay a user fee to support FDA activities related to its applications. Over the last several years, the time it takes for FDA to approve a generic drug has nearly doubled as FDA’s resources have not kept pace with an increasing number of Abbreviated New Drug Applications (ANDA) and other submissions related to generic drugs. The number of generic drug submissions sent annually to FDA has grown rapidly, reaching another record high this year, including nearly 1,000 ANDAs. Drug Master Files[6] have grown at a comparable pace and have reached similar heights. The current backlog of applications pending review is estimated to be over 2,500. The current median time to approval is approximately 31 months, though it should be noted that this includes time the application is back with the sponsor to answer any questions FDA may have about the application. • The regulatory challenge of ensuring safe, high-quality generic drugs includes inspecting manufactur