Abstract

CHEMISTRY, MANUFACTURING AND CONTROL (CMC) EVALUATIONS OF ANDA SUBMISSION IN THE USA

D. Prakash Reddy*, M. V. Nagabhushanam, G Yaswanth Sai, Ch Bala Madhu Kiran, Brahmaiah Bonthagarala, G. Ramakrishna and Y. Ratna Sindhu

ABSTRACT

Background: The Abbreviated New Drug Application commonly referred as ANDA is an application that contains data submitted to US FDA for the review and prospective marketing authorization of generic drugs. The conduct of the reviewing of the application is done by the Division of Filing Review (DFR), Office of Regulatory Operations (ORO) in the Office of Generic Drugs (OGD). The format of ANDA: USFDA recommends the submission of ANDA applications as per ICH Common Technical Document (CTD) format. Module 3: Module 3 of CTD contains Chemistry, Manufacturing and Control (CMC) information including all the supporting details verifying that was summarised in section 2.3 which is the quality overall summary. Evaluation of ANDA: For the evaluation of an Abbreviated New Drug Application in the US, its Office of Generic Drugs (OGD) has developed a Question-based Review (QbR) for its CMC section which is mainly focussed on the critical quality attributes. Conclusion: The implementation of Question- based Review programme is yielding good improvements in FDA’s division of Office of Generic Drugs (OGD), i.e., by advancing the review pattern of the ANDA CMC section without compromising quality and efficacy for the indication of the generic product.

Keywords: USFDA, Question-based Review, Chemistry Manufacturing and control, CTD, Module 3.