FDA CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality

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CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality[附网盘链接]是Food And Drug Administration于过去发布的FDA标准，适用于US。

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Draft — Not for Implementation 1 CDER’s Program for the Recognition of Voluntary Consensus 2 Standards Related to Pharmaceutical Quality 1

3 Guidance for Industry 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10 for this guidance as listed on the title page. 11 12 13 14 I. INTRODUCTION 15 2

16 FDA’s participation in the development and use of technical voluntary consensus standards has 17 been integral to the execution of FDA’s mission. For example, FDA has used such standards to 18 develop and/or evaluate performance characteristics of dosage forms, testing methodologies, 19 manufacturing practices, product standards, scientific protocols, compliance criteria, ingredient 20 specifications, labeling of drug products, and other technical or policy criteria. 21 22 This guidance describes a proposed program at FDA’s Center for Drug Evaluation and Research 23 (CDER) to make public a comprehensive listing of informally recognized voluntary consensus 24 standards related to pharmaceutical quality. CDER is issuing this draft guidance to obtain public 25 comments on the proposed program. After CDER considers submitted comments, CDER will 26 establish this program and describe it by publishing a final guidance. 27 28 This program, once established, will facilitate submissions by external stakeholders and CDER 29 staff proposing voluntary consensus standards related to pharmaceutical quality for informal 1

This guidance has been prepared by the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2

In this guidance, the phrase voluntary consensus standard refers to a standard that is developed or adopted by domestic and international voluntary consensus standards bodies . . . . These bodies often have . . . policies that include provisions requiring that owners of relevant patented technology incorporated into a standard make that intellectual property available to implementers of the standard on non-discriminatory and royalty-free or reasonable royalty terms. Office of Management and Budget Circular A-119 Revised, Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities (revised on January 27, 2016), available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A119/revised_circular_a-

119_as_of_1_22.pdf, at 16. Voluntary consensus standards bodies refer to any “association, organization, or technical society that plans, develops, establishes, or coordinates voluntary consensus standards using a voluntary consensus standards development process that includes [specific] attributes or elements.” Id. Section V.A of this guidance describes these attributes or elements.

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