1.6 Regulatory Framework: Governing Bodies and Guidelines
1.6 Regulatory Framework: Governing Bodies and Guidelines contains 6 topic pages in Phase 1 — Introduction to Pharmacological Research & Regulatory Framework.
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Topics
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1.6.1 CPCSEA (India)
The Committee for the Purpose of Control and Supervision of Experiments on Animals, operating under India's Ministry of Environment, Forest and Climate...
1.6.2 CDSCO and Schedule Y
The Central Drugs Standard Control Organisation is India's national regulatory authority for...
1.6.3 OECD Guidelines
The Organisation for Economic Co-operation and Development maintains a set of internationally harmonised test guidelines that define standardised protocols...
1.6.4 ICH S-Series and M3(R2)
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use publishes the S-series of safety guidelines,...
1.6.5 US-FDA 21 CFR
Title 21 of the US Code of Federal Regulations governs pharmaceutical development in the United...
1.6.6 WHO and EMA
The World Health Organization issues guidelines relevant to herbal and traditional medicines, while the European Medicines Agency's Committee for Medicinal...