Global Regulatory Landscape - GxP

🌍 Global Regulatory Landscape

Pharmaceuticals | Medical Devices | Food | Cosmetics | GxP

🌐 Global Harmonization Bodies

WHO

Global health authority with GMP, GCP guidelines

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ICH

Harmonized guidelines (Quality, Safety, Efficacy)

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PIC/S

GMP inspection cooperation across countries

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IMDRF

Medical device regulatory harmonization

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OECD

GLP and mutual data acceptance framework

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🌎 Major Regulatory Agencies

🇺🇸 US FDA

Drugs, Devices, Food, Cosmetics

21 CFR Visit Website

🇪🇺 EMA

European medicines regulation

EudraLex Visit Website

🇮🇳 CDSCO

India regulatory authority

Drugs & Cosmetics Act Visit Website

🇯🇵 PMDA

Japan pharma & device authority

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🇬🇧 MHRA

UK medicines regulator

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🇨🇦 Health Canada

Canada regulatory body

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🇦🇺 TGA

Australia therapeutic goods regulator

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🧪 Product-wise Regulations

💊 Pharmaceuticals

ICH Guidelines
WHO GMP
US 21 CFR 210/211
EU EudraLex
India Schedule M

🏥 Medical Devices

ISO 13485
ISO 14971
EU MDR/IVDR
FDA QSR

🍔 Food

Codex Alimentarius
FSMA (USA)
EFSA (EU)
FSSAI (India)

💄 Cosmetics

US FDA
EU Regulation 1223/2009
India Cosmetics Rules

🧬 Biologics

FDA CBER
EMA ATMP
ICH Q5 Series

⚙️ GxP Frameworks

Manufacturing

GMP GDP

Clinical

GCP GLP

Data Integrity

21 CFR Part 11 GAMP 5

Pharmacovigilance

ICH E2 FAERS EudraVigilance

🔗 Quick Access

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