Preferred Label : drug approval;

MeSH definition : Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.;

MeSH synonym : approvals, drug; approval, drug; drug approvals; food and drug administration drug approval;

Wikipedia automatic translation : Regulatory affairs;

MeSH Hyperonym : drug approval process; Approval Process, Drug; Approval Processes, Drug; Drug Approval Processes; Process, Drug Approval; Processes, Drug Approval;

MeSH hyponym : new drug approval process; new drug approval; food and drug administration drug approval process; Approval, New Drug; Approvals, New Drug; Drug Approval, New; Drug Approvals, New; New Drug Approvals;

MeSH annotation : by govt regulatory agency, U.S. (not restricted to FDA) or foreign;

Wikipedia link : https://en.wikipedia.org/wiki/Regulatory affairs;

Details


Main resources

You can consult :

Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.

https://ansm.sante.fr/documents/reference/recommandations-relatives-a-la-redaction-des-projets-dannexes-de-lamm
2024
false
false
false
France
French
guideline
drug approval
drug industry

---
https://cms.cmq.org/files/documents/Fiches/p-1-2023-04-19-fr-fiche23-conditions-amm-telemedecine.pdf
2023
Canada
scientific and technical information
drug approval
telemedicine
suicide, assisted
telemedicine
due to

---
https://ansm.sante.fr/documents/reference/referentiel-des-specialites-en-acces-derogatoire
2022
false
false
false
France
French
guidelines
drug approval
france
pharmaceutical preparations

---
https://ansm.sante.fr/actualites/traitements-contre-la-covid-19-la-commission-europeenne-accorde-une-autorisation-de-mise-sur-le-marche-au-paxlovid
2022
false
false
false
France
French
drug approval
europe
drug combinations
drug information
ritonavir
lactams
proline
leucine
nitriles
antiviral agents
COVID-19
adult
pregnancy
Anti-SARS-CoV-2 Polyclonal Antibodies XAV-19
antibodies, heterophile
conditional marketing authorisation
nirmatrelvir and ritonavir drug combination
nirmatrelvir
nirmatrelvir and ritonavir

---
https://ansm.sante.fr/actualites/traitement-du-cancer-du-sein-triple-negatif-autorisation-en-acces-precoce-du-medicament-trodelvy-sacituzumab-govitecan
2021
false
false
false
France
French
sacituzumab govitecan
drug information
drug approval
france
triple negative breast neoplasms
sacituzumab govitecan
camptothecin
camptothecin
immunoconjugates
antibodies, monoclonal, humanized

---
https://www.cpa-apc.org/wp-content/uploads/2021-CPA-Discussion-Paper-MAID-Challenges-and-Considerations-FR-web-Final.pdf
https://www.cpa-apc.org/wp-content/uploads/2021-CPA-Position-Statement-MAID-Update-FR-web-Final.pdf
2021
false
false
false
Canada
scientific and technical information
mental disorders
mental disorder, nos
drug approval
problem, nos
caregivers
homemaker services
suicide, assisted
persons
medical assistance
singular
single person
persons
medical assistance

---
https://ansm.sante.fr/dossiers-thematiques/covid-19-vaccins/covid-19-vaccins-autorises
2021
false
false
false
France
French
drug approval
france
drug information
mRNA vaccine
pneumonia, viral
coronavirus infections
pandemics
viral vaccines
coronavirus infections
COVID-19
COVID-19 Vaccines

---
Abecma (idecabtagene vicleucel): Authorization with conditions
https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/infovigilance-produits-sante/juin-2021.html#a5.3
2021
false
false
false
Canada
French
English
drug approval
canada
Idecabtagene Vicleucel
gene therapy
infusions, intravenous
multiple myeloma
adult
drug information
idecabtagene vicleucel
idecabtagene vicleucel
genetic therapy

---
https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/infovigilance-produits-sante/juin-2021.html#a5.4
2021
false
false
false
Canada
French
English
drug approval
canada
drug information
tepotinib
administration, oral
adult
carcinoma, non-small-cell lung
c-Met Inhibitor
protein kinase inhibitors
tepotinib
neoplasm metastasis
piperidines
pyridazines
pyrimidines

---
Authorization of Pfizer-BioNTech COVID-19 Vaccine with English-only Carton and Vial Labels
https://canadiensensante.gc.ca/recall-alert-rappel-avis/hc-sc/2020/74541a-fra.php
2020
false
false
false
Canada
French
English
drug information
drug approval
canada
adult
aged
mRNA vaccine
viral vaccines
coronavirus infections
pneumonia, viral
coronavirus infections
pandemics
COVID-19
COVID-19 Vaccines

---
https://covid.cadth.ca/fr/traitement-fr/groupe-consultatif-sur-la-mise-en-oeuvre-du-bamlanivimab/
https://covid.cadth.ca/fr/traitement-fr/le-bamlanivimab-dans-le-traitement-de-la-covid-19-evaluation-critique-de-lanalyse-intermediaire-de-lessai-blase-1/
2020
false
false
false
Canada
French
English
drug information
drug approval
canada
antibodies, monoclonal
adult
adolescent
drug monitoring
continuity of patient care
technical report
Evidence-Based medicine
bamlanivimab
COVID-19
antibodies, monoclonal, humanized

---
https://www.ansm.sante.fr/actualites/baclofene-dans-lalcoolo-dependance-le-conseil-detat-annule-la-decision-de-suspension-de-lamm-de-baclocur
2020
false
false
false
France
French
drug information
drug approval
france
baclofen
alcoholism
drugs used in alcohol dependence

---
https://solidarites-sante.gouv.fr/soins-et-maladies/medicaments/professionnels-de-sante/autorisation-de-mise-sur-le-marche/article/autorisations-temporaires-d-utilisation-atu
2019
false
true
false
France
drug approval
inpatients
drugs, investigational
drug information

---
https://www.ansm.sante.fr/actualites/baclofene-dans-lalcoolo-dependance-publication-de-lavis-du-csst-sur-le-rapport-benefice-risque
2018
false
false
false
France
French
drug information
baclofen
alcoholism
risk assessment
drug approval

---
https://www.ansm.sante.fr/actualites/lansm-publie-ses-recommandations-sur-les-noms-des-medicaments
2018
false
false
false
France
French
guideline
drug industry
pharmaceutical preparations
terminology as topic
drug approval
france
drug labeling
europe

---
https://www.ansm.sante.fr/actualites/spray-nasal-de-naloxone-nalscue-entree-en-vigueur-de-lamm-le-8-janvier-2018
2018
false
false
false
France
French
drug information
drug approval
france
naloxone
administration, intranasal
nasal sprays
narcotic antagonists
emergency treatment
Naloxone Hydrochloride
naloxone
poisoning
opiate alkaloids
drug users
Overdose of opiate (disorder)
patient education as topic

---
https://ansm.sante.fr/actualites/lansm-octroie-une-autorisation-de-mise-sur-le-marche-pour-une-utilisation-du-baclofene-dans-lalcoolo-dependance-communique
2018
false
false
false
false
France
French
drug approval
alcoholism
baclofen
product surveillance, postmarketing
france
drugs used in alcohol dependence
drug information

---
http://www.sudoc.fr/225391708
2017
false
true
false
France
French
dissertations, academic
drug approval
behavioral symptoms
antidepressive agents
dementia

---
http://www.oiiq.org/sites/default/files/uploads/periodiques/Perspective/vol13no5/11-pharmacovigilance-acfa.pdf
2016
false
false
false
Canada
French
drugs, generic
drug approval
journal article
therapeutic equivalency
pharmacovigilance
canada

---
http://www.orpha.net/orphacom/cahiers/docs/FR/liste_des_medicaments_orphelins_en_europe.pdf
2016
false
false
false
France
French
scientific and technical information
drug approval
rare diseases
orphan drug production
french abstract

---
https://apps.who.int/iris/handle/10665/242311
2015
false
false
false
Switzerland
scientific and technical information
dengue vaccines
drug approval
malaria vaccines
ebola vaccines
pregnancy
product surveillance, postmarketing
vaccines

---
http://avisdexperts.ch/videos/view/3749/1
2015
false
false
false
Switzerland
French
pharmaceutical preparations
Drug-Related side effects and adverse reactions
drug approval
drug evaluation
product surveillance, postmarketing
video recording

---
http://www.anses.fr/fr/content/cycle-de-vie-du-m%C3%A9dicament
2014
France
French
scientific and technical information
life cycle stages
pharmaceutical preparations
drug approval
france

---
http://www.social-sante.gouv.fr/actualite-presse,42/communiques,2322/sativex-r-l-autorisation-de-mise,16903.html
2014
France
French
drug approval
france
cannabis
drug information
multiple sclerosis
muscle spasticity

---
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/17195a-fra.php
2013
false
true
false
Canada
contraceptives, oral, hormonal
contraceptives, oral, hormonal
drug approval
canada

---
http://www.irdes.fr/Publications/Qes2013/Qes187.pdf
2013
false
true
false
France
French
journal article
hypoglycemic agents
hypoglycemic agents
hypoglycemic agents
drug approval
diffusion of innovation
hypoglycemic agents

---
http://agence-prd.ansm.sante.fr/php/ecodex/index.php
France
French
drug approval
pharmaceutical preparations
drug evaluation
database
directory
popular works
databases, pharmaceutical

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=66349668
2012
France
summary of product characteristics
package leaflet
tablets
drug approval

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=69899197
2012
France
summary of product characteristics
package leaflet
tablets
drug approval
buflomedil

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=65902347
2012
France
summary of product characteristics
package leaflet
drug approval
tablets
buflomedil

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=64383376
2012
France
summary of product characteristics
package leaflet
buflomedil
tablets
drug approval

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=62227072
2012
France
summary of product characteristics
package leaflet
buflomedil
tablets
drug approval

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=65571616
2012
France
summary of product characteristics
package leaflet
drug approval
tablets
buflomedil

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=68118585
2012
France
summary of product characteristics
package leaflet
buflomedil
drug approval
tablets

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=67937585
2012
France
summary of product characteristics
package leaflet
tablets
drug approval
buflomedil

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=64487713
2012
France
summary of product characteristics
package leaflet
tablets
drug approval
buflomedil

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=62991878
2012
France
summary of product characteristics
package leaflet
drug approval
buflomedil
tablets

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=69165431
2012
France
summary of product characteristics
package leaflet
tablets
drug approval
buflomedil

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=67975002
2012
France
summary of product characteristics
package leaflet
powders
suspensions
drug approval
cefaclor

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=64063999
2012
France
summary of product characteristics
package leaflet
administration, cutaneous
drug approval

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=64693948
2012
France
summary of product characteristics
package leaflet
powders
infant
drug approval

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=67797382
2012
France
summary of product characteristics
package leaflet
drug approval
gels

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=68742652
2012
France
summary of product characteristics
package leaflet
drug approval
infant
powders

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=67083416
2012
France
summary of product characteristics
package leaflet
drug approval
fluoxetine

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=62418729
2012
France
summary of product characteristics
package leaflet
drug approval
tablets

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=61096595
2012
France
summary of product characteristics
package leaflet
drug approval
injections

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=63247359
2012
France
summary of product characteristics
package leaflet
injections
drug approval

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=62426487
2012
France
summary of product characteristics
package leaflet
tablets
drug approval

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=64144091
2012
France
summary of product characteristics
package leaflet
drug approval
powders
infant
suspensions

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=69946316
2012
France
summary of product characteristics
package leaflet
chewing gum
pharmaceutical preparations
drug approval

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=65782684
2012
France
summary of product characteristics
package leaflet
pharmaceutical preparations
drug approval
chewing gum

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=65492097
2012
France
summary of product characteristics
package leaflet
Octagam
drug approval
Octagam

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=62556228
2012
France
summary of product characteristics
package leaflet
ointments
drug approval

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=69300060
2012
France
summary of product characteristics
package leaflet
arthritis, rheumatoid
injections
drug approval

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=68012468
2012
France
summary of product characteristics
package leaflet
drug approval
powders
propacetamol

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=60389677
2012
France
summary of product characteristics
package leaflet
propacetamol
powders
drug approval

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=64717833
2012
France
summary of product characteristics
package leaflet
drug approval
injections
powders

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=68755977
2012
France
summary of product characteristics
package leaflet
injections
drug approval
powders

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=68029478
2012
France
summary of product characteristics
package leaflet
drug approval
capsules

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=62035912
2012
France
summary of product characteristics
package leaflet
capsules
drug approval

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=61674031
2012
France
summary of product characteristics
package leaflet
capsules
drug approval

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=67373978
2012
France
summary of product characteristics
package leaflet
drug approval
capsules
sibutramine

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=63898156
2012
France
summary of product characteristics
package leaflet
drug approval
capsules
sibutramine

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=64270179
2012
France
summary of product characteristics
package leaflet
drug approval
suspensions
sucralfate
powders

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=64177821
2012
France
summary of product characteristics
package leaflet
tablets
drug approval

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=61079012
2012
France
summary of product characteristics
package leaflet
tablets
buflomedil
drug approval

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=61140629
2012
France
summary of product characteristics
package leaflet
tablets
drug approval
benfluorex

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=65580266
2012
France
summary of product characteristics
package leaflet
benfluorex
tablets
drug approval

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=67255976
2012
France
summary of product characteristics
package leaflet
drug approval
Octagam
Octagam
immunoglobulins
humans

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=64625071
2012
France
summary of product characteristics
package leaflet
drug approval
Irinotecan

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=69752496
2012
France
summary of product characteristics
package leaflet
drug approval
tablets
potassium iodide

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=63739816
2012
France
summary of product characteristics
package leaflet
potassium iodide
drug approval
tablets

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=69164361
2012
France
summary of product characteristics
package leaflet
glimepiride
tablets
drug approval
Rosiglitazone

---
http://agence-prd.ansm.sante.fr/php/ecodex/extrait.php?specid=68626295
2012
France
summary of product characteristics
package leaflet
drug approval
tablets
glimepiride
Rosiglitazone

---
https://www.ema.europa.eu/medicines/human/EPAR/Rebetol
2012
false
United Kingdom
French
English
syndication feed
ribavirin
Contraindications, Procedure
ribavirin
antiviral agents
hepatitis C, chronic
ribavirin
antiviral agents
ribavirin
antiviral agents
pregnancy
breast feeding
treatment outcome
adult
child
drug therapy, combination
drug labeling
drug approval
drug evaluation
summary of product characteristics
package leaflet
Contraindications, Drug

---
http://archives.uness.fr/sites/umvf/media/ressWikinu/Radiologie/DESRADIOLOGIE/MEDIAS/02_2011_Labo/Pub_2011_Labo/index.htm
2011
false
true
false
false
France
drug approval
insurance, health, reimbursement
pharmaceutical preparations
drugs, investigational
drugs, investigational
drugs, investigational
drugs, investigational
drugs, investigational
drug approval
drug approval
drug approval
audiovisual aids

---
http://archives.uness.fr/sites/umvf/media/ressMereEnfant/VAC/2011/13_brasseur/index.htm
2011
false
true
false
true
France
French
audiovisual aids
drug approval
drug approval
drug approval
drug approval
allergy and immunology
vaccines

---
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2011-guidance-directrice_reporting-notification/index-fra.php
2011
Canada
French
product surveillance, postmarketing
Drug-Related side effects and adverse reactions
drug approval
guidelines

---
http://www.legifrance.gouv.fr/affichTexte.do;jsessionid=?cidTexte=JORFTEXT000024810016&dateTexte=&oldAction=rechJO&categorieLien=id
2011
false
true
false
France
drug approval
legislation
disinfectants

---
http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=multiple.joint.health&lang=fra
2010
false
true
false
Canada
French
biological products
drug approval
drug industry
monograph pharmacy
joints

---
Summary Basis of Decision (SBD) for PRIMOVIST - Gadoxetate disodium
https://hpr-rps.hres.ca/reg-content/sommaire-motif-decision-detailOne.php?lang=fr&linkID=SBD00116
2010
false
Canada
French
English
gadolinium DTPA
contrast media
gadolinium ethoxybenzyl DTPA
magnetic resonance imaging
injections, intravenous
adult
liver diseases
canada
drug approval
gadolinium DTPA
drug information
liver diseases

---
http://www.health.belgium.be/fr/avis-ndeg-47-compassionate-use-et-medical-need
http://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/17812567/Avis%20n%C2%B0%2047%20du%209%20mars%202009%20relatif%20aux%20implications%20%C3%A9thiques%20de%20la%20l%C3%A9gislation%20concernant%20les%20programmes%20d%E2%80%99usage%20compassionnel%20%28compassionate%20use%29%20et%20l.pdf
2009
false
false
Belgium
French
drug approval
salvage therapy
investigational new drug application
drugs, investigational
scientific and technical information
public health guidelines

---
http://www.has-sante.fr/portail/jcms/c_672761/agrement-des-bases-de-donnees-sur-les-medicaments
2009
France
scientific and technical information
databases, pharmaceutical
drug approval

---
http://medecine-pharmacie.univ-rouen.fr/jsp/saisie/liste_fichiergw.jsp?OBJET=DOCUMENT&CODE=1192019758995&LANGUE=0
2007
France
French
drug approval
pharmacy
pharmaceutical preparations
pharmaceutical preparations
educational course

---
http://www.acadpharm.org/dos_public/_Importation_Parall_350les_avril_2007_1_.pdf
2007
France
French
drug approval
commerce
europe
health policy guidelines

---
http://www.senat.fr/rap/r05-382/r05-382.html
2006
France
French
drug approval
pharmaceutical preparations
technical report

---
http://www.irdes.fr/Publications/Qes/Qes60.pdf
2002
France
French
journal article
cyclooxygenase inhibitors
anti-inflammatory agents, non-steroidal
france
drug approval
drug prescriptions
sulfonamides
drug interactions

---
Nous contacter.
18/05/2024


[Home] [Top]

© Rouen University Hospital. Any partial or total use of this material must mention the source.