Pharmacovigilance regulatory actions by national pharmacovigilance centers in Arab countries following COVID-19 pandemic-Reference-Cited by-同舟云学术

Pharmacovigilance regulatory actions by national pharmacovigilance centers in Arab countries following COVID-19 pandemic

Published:2022-08-18 Issue:2 Volume:22 Page:165-174
ISSN:1474-0338
Container-title:Expert Opinion on Drug Safety
language:en
Short-container-title:Expert Opinion on Drug Safety

Author:

Al-Zubiedi Sameh A.¹²^ORCID,Younus Manal³^ORCID,Al-Khalidi Sara⁴^ORCID,Ekilo Magnus⁵,Alshammari Thamir M.⁴⁶^ORCID

Affiliation:

1. Department of Biopharmaceutics and Clinical Pharmacy, School of Pharmacy, The University of Jordan, Amman, Jordan

2. School of Pharmacy, University of Jordan Pharmacovigilance office, The University of Jordan, Amman, Jordan

3. Iraqi Pharmacovigilance Centre, Ministry of Health, Baghdad, Iraq

4. Medication Safety Research Centre, King Saud University, Riyadh, Saudi Arabia

5. Uppsala Monitoring Centre, Uppsala, Sweden

6. College of Pharmacy, Riyadh Elm University, Riyadh, Saudi Arabia

Publisher

Informa UK Limited

Subject

Pharmacology (medical),General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/14740338.2022.2108398

Reference27 articles.

1. New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19

2. The Role of Pharmacovigilance and ISoP During the Global COVID-19 Pandemic

3. US Food and Drug Administration (FDA). Postmarketing adverse event reporting for medical products and dietary supplements during a pandemic. [cited 2021 Mar 14]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-adverse-event-reporting-medical-products-and-dietary-supplements-during-pandemic

4. Medicines and Healthcare porducts Regulatory Agency (MHRA). MHRA regulatory flexibilities resulting from coronavirus (COVID-19) [cited 2021 Mar 14]. Available from: https://www.gov.uk/guidance/mhra-regulatory-flexibilities-resulting-from-coronavirus-covid-19

5. European Medicines Agency (EMA). Detailed guidance of ICSRs in the context of COVID-19: validity and coding ICSRs. [cited 2021 Mar 14]. Available from: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/detailed-guidance-icsrs-context-covid-19-validity-coding-icsrs_en.pdf