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Risk Based CMC Review An Update

This document summarizes the objectives and discussions from the October 21, 2002 ACPS meeting, led by Dr. Yuan-yuan Chiu of the FDA. It aims to compile a list of low-risk drugs regarding quality to minimize NDA/ANDA manufacturing supplements and reduce required CMC information for truncated ANDAs. The meeting sought to establish attributes, acceptance criteria, and eligibility evaluation based on GMP compliance using a three-tier process to define low-risk drugs. The discussions also involved contributions from key FDA scientists and ongoing workshops for enhancing drug review processes.

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Risk Based CMC Review An Update

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  1. Risk Based CMC ReviewAn Update ACPS Meeting October 21, 2002 Yuan-yuan Chiu, Ph.D. Director, ONDC/OPS, FDA

  2. Objectives • To compile a list of drugs (low risk with respect to quality) that will qualify for • the elimination of most of NDA/ANDA manufacturing supplements • reduced CMC information needed to be submitted to an original ANDA (Truncated ANDA - TANDA) and AR to an approved NDA/ANDA/TANDA

  3. Internal Discussion ACPS Meeting Scientific Workshop CMCCC & CCC Scientific Rounds Brown bag meetings November, 2000 July, 2001 AAPS Workshop - June, 2001 Background

  4. Tier 1 Tier 2 Tier 3 A. To establish attributes and acceptance criteria B. To propose a drug list To finalize the drug list after medical consultation To determine a firm’s eligibility by evaluating its GMP compliance A Three-Tier Process

  5. General Principleto Define Low Risk Drugs Low Probability of Detection Medium High Low Risk High Low Medium Complexity* *DS/DP characterization Mechanism of product performance Manufacturing technology

  6. Eric Duffy Paul Schwartz Marie Kowblansky Scott Furness Vilayat Sayeed Dan Boring Liang Zhou Members of Working GroupsDrug Substance Drug Product

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