Industry Proposals for Addressing Post-Approval Change Burdens Include Harmonizing on Commitments and Classifications

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Industry Proposals for Addressing Post-Approval Change Burdens Include Harmonizing on Commitments and Classifications

机译：行业解决Post-Approval的提议改变负担包括协调的承诺和分类

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Biopharmaceutical firms are calling for a global effort to decrease their heavy post-approval change filing burdens that would clarify and harmonize change classification and submission requirements on a risk-based foundation.

机译：呼吁全球生物制药公司从而减少重post-approval改变文件澄清和负担协调改变分类和提交要求一个基于风险的基础。

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《International Pharmaceutical Quality》 |2014年第2期|31-47|共17页
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正文语种英语
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Filing; Commitment; AddressingHeavycallsBiological Agents;

机译：文件,承诺;AddressingHeavycallsBiological代理;

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机译：化学品分类、标识和安全数据表全球协调体系The Globally Harmonized System for Classification，Labelling and Safety Data Sheets

Industry Proposals for Addressing Post-Approval Change Burdens Include Harmonizing on Commitments and Classifications

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