美国市场韩式防晒霜趋势及监管要求.pdf

1、 OTC Drug(Over-the-Counter)REACH24H KOREA2025 In-cosmetics koreaContentsCopyrightREACH24H2 OTC Drug OTC Drug OTC CopyrightREACH24H3 OTC Drug Part 1Part 1CopyrightREACH24H4 OTC Drug :2023 143 5 (CAGR):20242030 6.1%:1.,2.3.4.Part 1CopyrightREACH24H5 OTC Drug vs 2007,17%2024 43%,SB2571 Oxybenzone,Octin

2、oxate EWG(Environmental Working Group)80%(Zinc,Titanium):EWGPart 1CopyrightREACH24H6 OTC Drug (Drugs):,OTC(Over-the-Counter)Drug:(Cosmetics):,(Intended Use),(OTC ),Part 1CopyrightREACH24H7 OTC Drug (physiological)(physical),OTC Drug (Sunscreens)(T opical Acne Products)(Anti-dandruff)(Skin Protectant

3、)Part 1CopyrightREACH24H8 OTC Drug ,(Federal Food,Drug,and Cosmetic Act,FD&C Act),(The Code of Federal Regulations,CFR)FD&C Act CFR Title 21 21 CFR (Fair Packaging and Labeling Act,FPLA),OTC(OTC Monograph)OTC “”“rule book”,Part 1CopyrightREACH24H9 OTC Drug OTC(Monograph)OTC “”“rule book”,FDA OTC FDA

4、 (NDA)NDA GRAS*(),21 CFR parts 331-358 GRAS *GRAS(Generally Recognized As Safe):FDA Part 1CopyrightREACH24H10 OTC Drug OTC(Monograph)OTC OTC (NDA,New Drug Application)OTC FDA NDA(New Drug Application,)OTC PMA(Post Market Approval,)(Monograph)/(Final Order)OTC FDA GRAS PMA()*NDA Part 1CopyrightREACH2

5、4H11 OTC Drug ,(:),Part 1CopyrightREACH24H12 OTC Drug OTC :M001M010()Part 1CopyrightREACH24H13 OTC Drug Part A General Provisions()-M006.1:Scope()-M006.3:Definitions()Part B Active Ingredients()-M006.10:Acne active ingredients()-M006.20:Permitted combinations of active ingredients()Part C Labeling()

6、-M006.50:Labeling of acne drug products()OTC :M006 (Topical Acne Product)Part 1CopyrightREACH24H14 OTC Drug (Active Ingredients)OTC ,FDA Part 1CopyrightREACH24H15 OTC Drug (Active Ingredients)OTC GMP ,GMP ,1)API(,)2)3)4)5)6),7)Product Quality ReviewPart 1CopyrightREACH24H16 OTC Drug GMP ,/,/:/Master