上海cmc培訓(xùn)investigationalandmarketingnewdrugapplicationsintheus-資料下載頁(yè)
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【正文】 itted in Section** ICH Q8(R2) **Christine Moore, FDA, 2nd DIA China annual meeting, Beijing, May 2021 29 . FDA CMC Pilot Program on QbD** ? Objectives ? To provide participating firms an opportunity to submit CMC information demonstrating QbD ? To enable FDA to implement new QbD concepts ? Status ? Launched Nov 2021 ? 9 original and 2(3) supplemental NDAs accepted ? 11 approved, 1 withdrawn for nonCMC reasons ? Common factors ? Submission of design space ? Use of risk assessment ? Proposal of regulatory flexibility under firm’s quality system 30 Observations during CMC Pilot** ? Wide variety of design spaces proposed ? Most included drug product, some included drug substance ? Most included process parameters。 some included formulation ponents ? Developed using varied experimental techniques and mathematical models ? Several utilized risk assessment in development ? Wide variety of control strategies utilized ? Online analyzers ? Inprocess testing in lieu of endproduct tests ? Real time release testing using PAT 31 Oute of CMC Pilot** ? Pilot has provided valuable experience for industry and FDA in implementing QbD ? Explored elements of QbD in submissions ? Risk assessments ? Design spaces ? Proposals for flexible regulatory approaches ? Riskbased regulatory decisions were enabled ? Learning has been incorporated into ICH Q8(R2) ? Refinement of concepts is still ongoing ? QbD applications within and outside pilot program 32 Recent QbD Experiences** ? Number of QbD meetings and applications have been increasing ? Applications containing QbD elements received in 2021 and 2021 outside of pilot ? 12 NDAs ? 6 supplemental NDAs ? New proposals have contained challenging regulatory approaches ? Additional experience is helping to coalesce review approaches 33 Comparability Protocol – Definition ? Regulation: 21CFR (e) ? A CP is a prehensive, detailed plan that describes the specific ? type of proposed change ? tests and studies to be performed ? analytical procedures that will be utilized ? acceptance criteria to be achieved to demonstrate lack of an adverse effect on the product quality as it may relate to the safety and effectiveness of the drug product ? Submission and use of CP ? A CP can be submitted in an original NDA or a priorapproval supplement for approval ? A CP may justify a reduced reporting category for the particular change because the use of the protocol for that type of change reduces the potential risk of an adverse effect 34 Comparability Protocol – General Aspects ? Guidances ? Comparability Protocols – Chemistry, Manufacturing, and Controls Information (draft Feb 2021) (Applies to chemical entities and synthetic peptides) ? Comparability Protocols – Protein Drug Products and Biological Products – Chemistry, Manufacturing, and Controls Information (draft Sept 2021) ? Points to consider ? Wellplanned in advance ? Scientifically and technically sound (based on knowledge and understanding) ? Adequate and current to implement the change ? Specific to product, process, controls, and type of change 35 Closing Remarks ? IND in the . ? is an exception to the NDA under the law ? allows riskbased, phased approach to CMC ? encourages sponsor consultation with FDA (via preIND, EOP2, preNDA meetings) ? NDA was established long before ANDA in the . ? an NDA for each new chemical entity, new dosage form, etc., by each applicant。 but not for each new supplier/manufacturer ? follows ICH quality guidelines and CTDQ ? accepts electronic submission ? FDA encourages NDA submission based on QbD concept and approach ? More systematic and holistic than the minimal approach ? Science and riskbased from development through lifecycle ? Regulatory flexibility enable
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