FDA電子煙堿傳輸系統(tǒng)上市前申請指南

目錄
I.引言 1
II.背景 3
III.定義 6
A.配件 6
B.添加劑 6
C.組件或部件 6
D.涵蓋的煙草制品 7
E.電子煙 7
F.電子煙液 7
G.成品煙草制品 8
H.新型煙草制品 8
I.煙草制品 8
IV.討論 9
A.本指南適用的產(chǎn)品? 9
B.什么時候需要PMTA以及適用哪些強制性政策？ 10
C.ENDS PMTA審查的一般程序 11
D.ENDS產(chǎn)品的公共衛(wèi)生考慮 12
V.如何提交PMTA 17
VI.ENDS PMTA的內(nèi)容及格式 19
A.一般信息 20
B.目錄 21
C.描述性信息 21
D.產(chǎn)品樣品 23
E.標簽 24
F.環(huán)境評估 24
G.所有研究結(jié)果摘要 24
H.科學研究和分析 26
VII.電子煙液PMTA的補充建議 40
A.組件、成分和添加劑 40
B.香味物質(zhì) 40
VIII.電子煙PMTA的補充建議 42
A.電子煙設計應考慮的因素 42
B.電子煙組件或部件子類別可能的設計參數(shù) 43
IX.對電子煙液和電子煙包裝在一起的ENDS產(chǎn)品的補充建議 46
X.科學研究和分析的其他考慮因素 47
A.在美國進行隨機對照臨床試驗的替代方案 47
B.文獻綜述? 48
C.對已發(fā)表文獻和公共數(shù)據(jù)集的分析 49
D.主文件 49
E.與其他產(chǎn)品的橋接研究 50
XI.上市后要求 51
XII.與FDA的會面請求 52
XIII.小企業(yè)援助辦公室 54
Contents
I.Introduction 55
II.Background 58
III.Definitions 61
A.Accessory 61
B.Additive 62
C.Component or Part 62
D.Covered Tobacco Product 62
E.E-cigarette 63
F.E-liquids 63
G.Finished Tobacco Product 64
H.New Tobacco Product 64
I.Tobacco Product 64
IV.Discussion 66
A.Products to Which This Guidance Applies 66
B.When Are PMTAs Required and What Enforcement Policies Apply? 67
C.General Procedures for ENDS PMTA Review 69
D.Public Health Considerations for ENDS Products 71
V.How to Submit a PMTA 79
VI.Content and Format of a Premarket Tobacco Product Application for ENDS Products 81
A.General Information 83
B.Table of Contents 84
C.Descriptive Information 84
D.Product Samples 87
E.Labeling 87
F.Environmental Assessment 88
G.Summary of All Research Information 89
H.Scientific Studies and Analyses 91
VII.Additional Recommendations for Premarket Tobacco Product
Applications for E-Liquid Products 112
A.Components， Ingredients， and Additives 112
B.Flavors 112
VIII.Additional Recommendations for Premarket Tobacco Product
Applications for E-Cigarettes 114
A.E-cigarette Design Factors to Consider 114
B.Possible Design Parameters for Subcategories of E-cigarette Components and Parts 115
IX.Additional Recommendations for ENDS Products that Package E-Liquids and E-Cigarettes Together 120
X.Additional Considerations for Scientific Studies and Analyses 121
A.Alternatives to U.S.-Conducted Randomized Controlled Clinical Trials 122
B.Literature Reviews 122
C.Analysis of Published Literature and Public Datasets 124
D.Master Files 124
E.Bridging 125
XI.Postmarket Requirements 127
XII.Requesting Meetings With FDA 128
XIII.Office of Small Business Assistance 130