Richtlijnen Kennisbank

Zoek in huidige versies, vergelijk publicatiegeschiedenis en download bronbestanden vanuit één portaal.

Organisatie

Onderwerp

Type

Status

Publicatie vanaf

Publicatie tot

Actieve filters: Organisatie: European Medicines Agency Reset

Beschikbare richtlijnen

116 resultaten

Annex to the evaluation guide for the GMP regulatory compliance programme — audit checklist on implementation of EU legislation (Revision 3)

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice/joint-audit-programme).

GMP EMA

Laatste versie Tijdlijn bekijken
Concept paper on the revision of the GMP guidelines — Annex 15: Qualification and Validation

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/good-manufacturing-practice-gmp-good-distribution-practice-gdp-inspectors-working-group).

GDP EMA

Laatste versie Tijdlijn bekijken
Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2025

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/good-manufacturing-practice-gmp-good-distribution-practice-gdp-inspectors-working-group).

GDP EMA

Laatste versie Tijdlijn bekijken
3-year work plan for the GMP/GDP Inspectors Working Group (2026–2028)

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/good-manufacturing-practice-gmp-good-distribution-practice-gdp-inspectors-working-group).

GDP EMA

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

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

Gepubliceerd: 9 sep 2026 GMP EMA

Laatste versie Tijdlijn bekijken
Validation issues frequently seen with initial marketing authorisation holders

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

GMP EMA

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

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

GMP EMA

Laatste versie Tijdlijn bekijken
The European Medicines Agency Road Map to 2015: The Agency’s Contribution to Science, Medicines, Health

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

GMP EMA

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

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

GMP EMA

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

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

GMP EMA

Laatste versie Tijdlijn bekijken

Nieuwsbrief

Ontvang richtlijnupdates in uw mailbox

Schrijf u in voor belangrijke GMP/GDP-wijzigingen, nieuwe publicaties en updates in tijdlijnen.

We gaan zorgvuldig met uw gegevens om. Lees ons privacybeleid .

Resources

Opleiding

Populaire Categorieën

GMP voor het Middenkader in de Farmaceutische Industrie

Training GMP voor het Middenkader – Farmaceutische Industrie (België)

Richtlijnen Kennisbank

Beschikbare richtlijnen

Annex to the evaluation guide for the GMP regulatory compliance programme — audit checklist on implementation of EU legislation (Revision 3)

Concept paper on the revision of the GMP guidelines — Annex 15: Qualification and Validation

Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2025

3-year work plan for the GMP/GDP Inspectors Working Group (2026–2028)

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

Ontvang richtlijnupdates in uw mailbox