Regulatory Insights
Global Nutraceutical | Dietary Supplements
India
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Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016
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Food Safety and Standards (Advertising and Claims) Regulation, 2018
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Amendments on Food Safety and Standards (Advertising and Claims) Regulation, 2020
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Amendments on Food Safety and Standards (Advertising and Claims) Regulation, 2022
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Food Safety and Standards (Labelling and Display) Regulations, 2020
US
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Dietary Supplements Guidance Documents & Regulatory Information
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Evidence-Based Review System for the Scientific Evaluation of Health Claims
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Qualified Health Claims-Labelling of Human Food-Dietary Supplements
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Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
Canada
Japan
ASEAN
EFSA Cosmetics | Personal Care Products | OTC
India
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PCD 19 (Cosmetics) IS 4011: 2018 Methods of test for safety evaluation of cosmetics (Third Revision)
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Scouring Products for utensil cleaning specification
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Safety evaluation of bathing bar and toilet soaps – Methods of test
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Quarternary ammonium compound based surface cleaner, liquid — specification
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Product manual for sanitary napkins according to is 5405:2019
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Methods of safety evaluation of synthetic detergents — tests for skin irritation and sensitization potential of synthetic detergents
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Toilet cleaner, liquid – specification (first revision)
Health Canada
Japan
Europe
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Guidelines for Cosmetic Product Claim Substantiation
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Guidelines for the Evaluation of the Efficacy of Cosmetic Products, Revised version May, 2008
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Product Test Guidelines for the Assessment of Human Skin Compatibility, 1997
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Guidelines for the Safety Assessment of a Cosmetic Product, 2004
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Guidelines for Assessment of Skin Tolerance of Potentially Irritant Cosmetic Ingredients, 1997
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Europe - Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas — Test method and requirements (phase 2, step 1)
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Chemical disinfectants and antiseptics — Hygienic handwash — Test method and requirements (phase 2/step 2)
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Supporting claims and indications for listed
medicines
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U.S. and EU Cosmetics Regulation
Pharmaceuticals
India
Europe
US
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Quality Systems Approach to Pharmaceutical CGMP Regulations
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Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
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Importation of Certain FDAApproved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 01(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act
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Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice