Global Regulatory Landscape - GxP

๐ŸŒ Global Regulatory Landscape

Pharmaceuticals | Medical Devices | Food | Cosmetics | GxP

๐ŸŒ 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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๐ŸŒŽ Major Regulatory Agencies

๐Ÿ‡บ๐Ÿ‡ธ US FDA

Drugs, Devices, Food, Cosmetics

21 CFR Visit Website

๐Ÿ‡ช๐Ÿ‡บ EMA

European medicines regulation

EudraLex Visit Website

๐Ÿ‡ฎ๐Ÿ‡ณ CDSCO

India regulatory authority

Drugs & Cosmetics Act Visit Website

๐Ÿ‡ฏ๐Ÿ‡ต PMDA

Japan pharma & device authority

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๐Ÿ‡ฌ๐Ÿ‡ง MHRA

UK medicines regulator

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๐Ÿ‡จ๐Ÿ‡ฆ Health Canada

Canada regulatory body

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๐Ÿ‡ฆ๐Ÿ‡บ TGA

Australia therapeutic goods regulator

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๐Ÿงช Product-wise Regulations

๐Ÿ’Š Pharmaceuticals

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

๐Ÿฅ Medical Devices

ISO 13485
ISO 14971
EU MDR/IVDR
FDA QSR

๐Ÿ” Food

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

๐Ÿ’„ Cosmetics

US FDA
EU Regulation 1223/2009
India Cosmetics Rules

๐Ÿงฌ Biologics

FDA CBER
EMA ATMP
ICH Q5 Series

โš™๏ธ GxP Frameworks

Manufacturing

GMP GDP

Clinical

GCP GLP

Data Integrity

21 CFR Part 11 GAMP 5

Pharmacovigilance

ICH E2 FAERS EudraVigilance

๐Ÿ”— Quick Access

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