Guideline Knowledge Base
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Available Guidelines
108 matches
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Establishes the status and applicability of the FDA's current good manufacturing practice regulations for drugs, and the definitions used throughout parts 211, 213, 225 and 226. Amended by 89 FR 51769 (18 June 2024, effective 18 December 2025) to add part 213 for medical gases.
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/scientific-guidelines.xml).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).
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