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21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
Gepubliceerd en

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.

Ingangsdatum: 18 dec 2025 GMP FDA

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Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with revision 2 of Module III on pharmacovigilance inspections
en

Imported from European Medicines Agency (https://www.ema.europa.eu/en/scientific-guidelines.xml).

Gepubliceerd: 9 sep 2026 GMP EMA

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Validation issues frequently seen with initial marketing authorisation holders
en

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

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Uptake of the traditional-use registration scheme and implementation of the provisions of Directive 2004/24/EC in European Union Member States
en

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products).

GMP EMA

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The European Medicines Agency Road Map to 2015: The Agency’s Contribution to Science, Medicines, Health
en

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

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Standard operating procedure for consultation of environmental competent authorities on genetically modified organisms with respect to environmental risk assessment in product evaluation (human use)
en

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

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Sponsor's report on the maintenance of the designation criteria at the time of marketing authorisation for a designated orphan-medicinal-product
en

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

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Scientific aspects and working definitions for the mandatory scope of the centralised procedure
en

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

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Request for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004' to be replaced by 'Briefing Note and Recommendations on a Request for Accelerated Assessment Pursuant to Article 14 (9) of Regulation (EC) No 726/2004 - Template
en

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

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Questions and answers: improving the understanding of normal operating range (NOR), proven acceptable range (PAR), design space (DSp) and normal variability of process parameters (EMA/CHMP/CVMP/QWP/354895/2017)
en

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

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Beschikbare richtlijnen

21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with revision 2 of Module III on pharmacovigilance inspections

Validation issues frequently seen with initial marketing authorisation holders

Uptake of the traditional-use registration scheme and implementation of the provisions of Directive 2004/24/EC in European Union Member States

The European Medicines Agency Road Map to 2015: The Agency’s Contribution to Science, Medicines, Health

Standard operating procedure for consultation of environmental competent authorities on genetically modified organisms with respect to environmental risk assessment in product evaluation (human use)

Sponsor's report on the maintenance of the designation criteria at the time of marketing authorisation for a designated orphan-medicinal-product

Scientific aspects and working definitions for the mandatory scope of the centralised procedure

Request for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004' to be replaced by 'Briefing Note and Recommendations on a Request for Accelerated Assessment Pursuant to Article 14 (9) of Regulation (EC) No 726/2004 - Template

Questions and answers: improving the understanding of normal operating range (NOR), proven acceptable range (PAR), design space (DSp) and normal variability of process parameters (EMA/CHMP/CVMP/QWP/354895/2017)

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