Regulatory Challenges in the COVID-19 Era: The Case of Tunisia.
Identifieur interne : 000D49 ( Main/Exploration ); précédent : 000D48; suivant : 000D50Regulatory Challenges in the COVID-19 Era: The Case of Tunisia.
Auteurs : Dora Cherif [Tunisie] ; Hajer Felfel [Tunisie] ; Chema Drira [Tunisie] ; Mariam Aounallah [Tunisie] ; Meriem Kadri [Tunisie] ; Mohamed Chiheb Ben Rayana [Tunisie] ; Myriam Razgallah Khrouf [Tunisie]Source :
- Disaster medicine and public health preparedness [ 1938-744X ] ; 2020.
Abstract
In view of the possible disruptions in the manufacturing and supply of health products following the coronavirus disease 2019 (COVID-19) pandemic, the Tunisian medicines regulatory authority was mobilized to guarantee patient safety. Teleworking has become the ultimate way of service continuity. The planning was revised according to health priorities. Work procedures were set online. A minimum list of medicines known as "medicines of health and strategic interest" was established. The Directorate of Pharmacy and Medicines (DPM) has been working on updating medicines stock data. A provisional suspension of authorizations for medicines export for 1 mo was decided. A fast-track procedure allowing the validation of alternative sources of raw materials has been put in place. An appeal for a fast track manufacture of hydroalcoholic gel/solutions was launched. A Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) procedure has been adopted in order to dispense off-label prescriptions of hydroxychloroquine and azithromycin combination. Focus groups were organized in order to set up therapeutic trials exploring possible strategies of COVID-19 treatment, such as serotherapy and BCG vaccine. This proactive and anticipatory policy has made it possible to meet the health challenges dictated by this crisis.
DOI: 10.1017/dmp.2020.432
PubMed: 33143805
PubMed Central: PMC7943945
Affiliations:
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regulatory authority was mobilized to guarantee patient safety. Teleworking has become the ultimate way of service continuity. The planning was revised according to health priorities. Work procedures were set online. A minimum list of medicines known as "medicines of health and strategic interest" was established. The Directorate of Pharmacy and Medicines (DPM) has been working on updating medicines stock data. A provisional suspension of authorizations for medicines export for 1 mo was decided. A fast-track procedure allowing the validation of alternative sources of raw materials has been put in place. An appeal for a fast track manufacture of hydroalcoholic gel/solutions was launched. A Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) procedure has been adopted in order to dispense off-label prescriptions of hydroxychloroquine and azithromycin combination. Focus groups were organized in order to set up therapeutic trials exploring possible strategies of COVID-19 treatment, such as serotherapy and BCG vaccine. This proactive and anticipatory policy has made it possible to meet the health challenges dictated by this crisis.</div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">33143805</PMID><DateRevised><Year>2021</Year><Month>03</Month><Day>12</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1938-744X</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2020</Year><Month>Nov</Month><Day>04</Day></PubDate></JournalIssue><Title>Disaster medicine and public health preparedness</Title><ISOAbbreviation>Disaster Med Public Health Prep</ISOAbbreviation></Journal><ArticleTitle>Regulatory Challenges in the COVID-19 Era: The Case of Tunisia.</ArticleTitle><Pagination><MedlinePgn>1-2</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1017/dmp.2020.432</ELocationID><Abstract><AbstractText>In view of the possible disruptions in the manufacturing and supply of health products following the coronavirus disease 2019 (COVID-19) pandemic, the Tunisian medicines regulatory authority was mobilized to guarantee patient safety. Teleworking has become the ultimate way of service continuity. The planning was revised according to health priorities. Work procedures were set online. A minimum list of medicines known as "medicines of health and strategic interest" was established. The Directorate of Pharmacy and Medicines (DPM) has been working on updating medicines stock data. A provisional suspension of authorizations for medicines export for 1 mo was decided. A fast-track procedure allowing the validation of alternative sources of raw materials has been put in place. An appeal for a fast track manufacture of hydroalcoholic gel/solutions was launched. A Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) procedure has been adopted in order to dispense off-label prescriptions of hydroxychloroquine and azithromycin combination. Focus groups were organized in order to set up therapeutic trials exploring possible strategies of COVID-19 treatment, such as serotherapy and BCG vaccine. This proactive and anticipatory policy has made it possible to meet the health challenges dictated by this crisis.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Cherif</LastName><ForeName>Dora</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Directorate of Pharmacy and Medicines, Tunis, Tunisia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Faculty of Pharmacy, University of Monastir, Monastir, Tunisia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Felfel</LastName><ForeName>Hajer</ForeName><Initials>H</Initials><Identifier Source="ORCID">https://orcid.org/0000-0001-9577-3599</Identifier><AffiliationInfo><Affiliation>Faculty of Pharmacy, University of Monastir, Monastir, Tunisia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>National medicines Control Laboratory, Tunis, Tunisia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Drira</LastName><ForeName>Chema</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Faculty of Pharmacy, University of Monastir, Monastir, Tunisia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Marrow Bone Transplant Center, Tunis, Tunisia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Aounallah</LastName><ForeName>Mariam</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Directorate of Pharmacy and Medicines, Tunis, Tunisia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kadri</LastName><ForeName>Meriem</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Directorate of Pharmacy and Medicines, Tunis, Tunisia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ben Rayana</LastName><ForeName>Mohamed Chiheb</ForeName><Initials>MC</Initials><AffiliationInfo><Affiliation>Faculty of Pharmacy, University of Monastir, Monastir, Tunisia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>National medicines Control Laboratory, Tunis, Tunisia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Razgallah Khrouf</LastName><ForeName>Myriam</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Directorate of Pharmacy and Medicines, Tunis, Tunisia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Faculty of Pharmacy, University of Monastir, Monastir, Tunisia.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>11</Month><Day>04</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Disaster Med Public Health 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IdType="doi">10.1017/dmp.2020.432</ArticleId><ArticleId IdType="pmc">PMC7943945</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>N Engl J Med. 2020 Mar 26;382(13):1268-1269</Citation><ArticleIdList><ArticleId IdType="pubmed">32109011</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet Public Health. 2020 May;5(5):e243-e244</Citation><ArticleIdList><ArticleId IdType="pubmed">32275858</ArticleId></ArticleIdList></Reference><Reference><Citation>Int J Surg. 2020 Jun;78:185-193</Citation><ArticleIdList><ArticleId IdType="pubmed">32305533</ArticleId></ArticleIdList></Reference><Reference><Citation>Nat Hum Behav. 2020 May;4(5):460-471</Citation><ArticleIdList><ArticleId IdType="pubmed">32355299</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>Tunisie</li></country><region><li>Gouvernorat de Tunis</li></region><settlement><li>Tunis</li></settlement></list><tree><country name="Tunisie"><region 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