Submission process streamlined

While the efficiency of the NDA and BLA review process has greatly improved, dramatically decreasing the time for regulatory review, the same cannot be said for overall drug development time, from identification of a new drug candidate to NDA or BLA submission, which has resisted the anticipated streamlining effects of new technologies and efficiencies. 

The ANDA is intended to streamline the review process for genetic versions of approved drug products. It was originally designed with two complimentary intents to reduce the review time and work effort involved in review of New Drug Applications and to provide a simplified pathway for submission of applications for generic versions of already approved drugs. The ANDA has earned a positive track record in both of these areas. 

The HPFB continues to ensure that the drug review process is as efficient as possible. It has taken several steps to streamline the process, including electronic submission, using a team approach, upgrading information technology, and strengthening scientific resources. 

The anticipated benefits to industry of this harmonized approach are straightforward. The need for duplicate studies in many clinical and biological areas is minimized. The common technical document will enable companies to prepare submissions more quickly, since a single technical dossier will be accepted by all authorities in the ICH areas. Overall, the drug development process will be streamlined, facilitating the process by which raw research is transformed into marketable drugs. 

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