FDA Cannabis and Cannabis-Derived Compounds Quality Considerations for Clinical Research

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Cannabis and Cannabis-Derived Compounds Quality Considerations for Clinical Research[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于U.S。

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Draft — Not for Implementation 1 Cannabis and Cannabis-Derived Compounds: Quality 2 Considerations for Clinical Research 1

3 Guidance for Industry 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic.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 15 I. INTRODUCTION 16 17 This guidance outlines FDA’s current thinking on several topics relevant to clinical research 2

18 related to the development of drugs containing cannabis or cannabis-derived compounds. 19 Cannabis and cannabis-derived compounds that may be used in drug manufacturing include 20 botanical raw materials, extracts, and highly purified substances of botanical origin. This 21 guidance does not address development of fully synthetic versions of substances that occur in 22 cannabis, sometimes known as cannabis-related compounds, which are regulated like other fully 23 synthetic drugs. This guidance is limited to the development of human drugs and does not cover 24 other FDA-regulated products. 25 26 The recommendations in this guidance are intended to provide clarity regarding a recent 27 legislative change (see section III) and to address certain questions raised in a recent public 3

28 hearing. The guidance also introduces key FDA regulatory concepts to stakeholders who may 29 be less familiar with FDA or our authorities than other drug developers. 30 31 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 32 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 33 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 34 the word should in Agency guidances means that something is suggested or recommended, but 35 not required. 36 37 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

For discussion of terms used in this guidance, see FDA and Cannabis: Research and Drug Approval Process at https://www.fda.gov/news-events/public-health-focus/fda-and-cannabis-research-and-drug-approval-process. 3

“Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds.” Public hearing, May 31, 2019. https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/scientific-data-

and-information-about-products-containing-cannabis-or-cannabis-derived-compounds

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