Role of the French drug licensing authority in the prevention of influenza pandemics.
Identifieur interne : 000703 ( Main/Exploration ); précédent : 000702; suivant : 000704Role of the French drug licensing authority in the prevention of influenza pandemics.
Auteurs : M. Aymard [France] ; J P CanoSource :
- European journal of epidemiology [ 0393-2990 ] ; 1994.
Descripteurs français
- KwdFr :
- Animaux (MeSH), Autorisation d'exercer (MeSH), Contrôle des médicaments et des stupéfiants (MeSH), Embryon de poulet (MeSH), Europe (MeSH), France (MeSH), Grippe humaine (prévention et contrôle), Grippe humaine (épidémiologie), Humains (MeSH), Laboratoires (MeSH), Prise de décision (MeSH), Technologie pharmaceutique (MeSH), Vaccins antigrippaux (normes), Vaccins antigrippaux (ressources et distribution), Vaccins inactivés (normes), Vaccins inactivés (ressources et distribution), Épidémies de maladies (prévention et contrôle).
- MESH :
- normes : Vaccins antigrippaux, Vaccins inactivés.
- prévention et contrôle : Grippe humaine, Épidémies de maladies.
- ressources et distribution : Vaccins antigrippaux, Vaccins inactivés.
- épidémiologie : Grippe humaine.
- Animaux, Autorisation d'exercer, Contrôle des médicaments et des stupéfiants, Embryon de poulet, Europe, France, Humains, Laboratoires, Prise de décision, Technologie pharmaceutique.
- Wicri :
- geographic : France.
English descriptors
- KwdEn :
- Animals (MeSH), Chick Embryo (MeSH), Decision Making (MeSH), Disease Outbreaks (prevention & control), Drug and Narcotic Control (MeSH), Europe (MeSH), France (MeSH), Humans (MeSH), Influenza Vaccines (standards), Influenza Vaccines (supply & distribution), Influenza, Human (epidemiology), Influenza, Human (prevention & control), Laboratories (MeSH), Licensure (MeSH), Technology, Pharmaceutical (MeSH), Vaccines, Inactivated (standards), Vaccines, Inactivated (supply & distribution).
- MESH :
- chemical , standards : Influenza Vaccines, Vaccines, Inactivated.
- chemical , supply & distribution : Influenza Vaccines, Vaccines, Inactivated.
- geographic : Europe, France.
- epidemiology : Influenza, Human.
- prevention & control : Disease Outbreaks, Influenza, Human.
- Animals, Chick Embryo, Decision Making, Drug and Narcotic Control, Humans, Laboratories, Licensure, Technology, Pharmaceutical.
Abstract
The French Drug Agency is responsible for the control and delivery of batch release certificates. In the case of an influenza pandemic, the use of inactivated vaccines, produced according to well-established procedures and controlled according to the European Pharmacopea and FDA requirements, will be strictly dependent on the necessary delays for production and controls. Mutual recognition between the National Control Laboratories in Europe might help in shortening the delays. If new, inactivated vaccines are produced either on cell cultures or by using genetically modified organisms, and if live attenuated vaccines are needed, it would be suitable to organize ad hoc working groups and international collaborative studies in fields of both research and regulation.
DOI: 10.1007/BF01719689
PubMed: 7843369
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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Aymard</name><affiliation wicri:level="3"><nlm:affiliation>National Influenza Reference Centre, Lyon, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>National Influenza Reference Centre, Lyon</wicri:regionArea><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Cano, J P" sort="Cano, J P" uniqKey="Cano J" first="J P" last="Cano">J P Cano</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="1994">1994</date><idno type="RBID">pubmed:7843369</idno><idno type="pmid">7843369</idno><idno type="doi">10.1007/BF01719689</idno><idno type="wicri:Area/Main/Corpus">000704</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000704</idno><idno type="wicri:Area/Main/Curation">000704</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000704</idno><idno type="wicri:Area/Main/Exploration">000704</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Role of the French drug licensing authority in the prevention of influenza pandemics.</title><author><name sortKey="Aymard, M" sort="Aymard, M" uniqKey="Aymard M" first="M" last="Aymard">M. Aymard</name><affiliation wicri:level="3"><nlm:affiliation>National Influenza Reference Centre, Lyon, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>National Influenza Reference Centre, Lyon</wicri:regionArea><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Cano, J P" sort="Cano, J P" uniqKey="Cano J" first="J P" last="Cano">J P Cano</name></author></analytic><series><title level="j">European journal of epidemiology</title><idno type="ISSN">0393-2990</idno><imprint><date when="1994" type="published">1994</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Animals (MeSH)</term><term>Chick Embryo (MeSH)</term><term>Decision Making (MeSH)</term><term>Disease Outbreaks (prevention & control)</term><term>Drug and Narcotic Control (MeSH)</term><term>Europe (MeSH)</term><term>France (MeSH)</term><term>Humans (MeSH)</term><term>Influenza Vaccines (standards)</term><term>Influenza Vaccines (supply & distribution)</term><term>Influenza, Human (epidemiology)</term><term>Influenza, Human (prevention & control)</term><term>Laboratories (MeSH)</term><term>Licensure (MeSH)</term><term>Technology, Pharmaceutical (MeSH)</term><term>Vaccines, Inactivated (standards)</term><term>Vaccines, Inactivated (supply & distribution)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Animaux (MeSH)</term><term>Autorisation d'exercer (MeSH)</term><term>Contrôle des médicaments et des stupéfiants (MeSH)</term><term>Embryon de poulet (MeSH)</term><term>Europe (MeSH)</term><term>France (MeSH)</term><term>Grippe humaine (prévention et contrôle)</term><term>Grippe humaine (épidémiologie)</term><term>Humains (MeSH)</term><term>Laboratoires (MeSH)</term><term>Prise de décision (MeSH)</term><term>Technologie pharmaceutique (MeSH)</term><term>Vaccins antigrippaux (normes)</term><term>Vaccins antigrippaux (ressources et distribution)</term><term>Vaccins inactivés (normes)</term><term>Vaccins inactivés (ressources et distribution)</term><term>Épidémies de maladies (prévention et contrôle)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="standards" xml:lang="en"><term>Influenza Vaccines</term><term>Vaccines, Inactivated</term></keywords><keywords scheme="MESH" type="chemical" qualifier="supply & distribution" xml:lang="en"><term>Influenza Vaccines</term><term>Vaccines, Inactivated</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Europe</term><term>France</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" qualifier="normes" xml:lang="fr"><term>Vaccins antigrippaux</term><term>Vaccins inactivés</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Disease Outbreaks</term><term>Influenza, Human</term></keywords><keywords scheme="MESH" qualifier="prévention et contrôle" xml:lang="fr"><term>Grippe humaine</term><term>Épidémies de maladies</term></keywords><keywords scheme="MESH" qualifier="ressources et distribution" xml:lang="fr"><term>Vaccins antigrippaux</term><term>Vaccins inactivés</term></keywords><keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Grippe humaine</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Animals</term><term>Chick Embryo</term><term>Decision Making</term><term>Drug and Narcotic Control</term><term>Humans</term><term>Laboratories</term><term>Licensure</term><term>Technology, Pharmaceutical</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Animaux</term><term>Autorisation d'exercer</term><term>Contrôle des médicaments et des stupéfiants</term><term>Embryon de poulet</term><term>Europe</term><term>France</term><term>Humains</term><term>Laboratoires</term><term>Prise de décision</term><term>Technologie pharmaceutique</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>France</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The French Drug Agency is responsible for the control and delivery of batch release certificates. In the case of an influenza pandemic, the use of inactivated vaccines, produced according to well-established procedures and controlled according to the European Pharmacopea and FDA requirements, will be strictly dependent on the necessary delays for production and controls. Mutual recognition between the National Control Laboratories in Europe might help in shortening the delays. If new, inactivated vaccines are produced either on cell cultures or by using genetically modified organisms, and if live attenuated vaccines are needed, it would be suitable to organize ad hoc working groups and international collaborative studies in fields of both research and regulation.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">7843369</PMID><DateCompleted><Year>1995</Year><Month>03</Month><Day>08</Day></DateCompleted><DateRevised><Year>2019</Year><Month>09</Month><Day>04</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0393-2990</ISSN><JournalIssue CitedMedium="Print"><Volume>10</Volume><Issue>4</Issue><PubDate><Year>1994</Year><Month>Aug</Month></PubDate></JournalIssue><Title>European journal of epidemiology</Title><ISOAbbreviation>Eur. J. Epidemiol.</ISOAbbreviation></Journal><ArticleTitle>Role of the French drug licensing authority in the prevention of influenza pandemics.</ArticleTitle><Pagination><MedlinePgn>507-8</MedlinePgn></Pagination><Abstract><AbstractText>The French Drug Agency is responsible for the control and delivery of batch release certificates. In the case of an influenza pandemic, the use of inactivated vaccines, produced according to well-established procedures and controlled according to the European Pharmacopea and FDA requirements, will be strictly dependent on the necessary delays for production and controls. Mutual recognition between the National Control Laboratories in Europe might help in shortening the delays. 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