Zobrazeno 1 - 10
of 593
pro vyhledávání: '"Regulatory authorities"'
Autor:
E. V. Shubnikova
Publikováno v:
Безопасность и риск фармакотерапии, Vol 12, Iss 3, Pp 309-330 (2024)
INTRODUCTION. Postmarketing surveillance is the main mechanism to monitor and evaluate the safety of drugs approved for widespread clinical use. This mechanism provides up-to-date information on adverse drug reactions and facilitates the implementati
Externí odkaz:
https://doaj.org/article/4627d7be30994585930da3fb93840522
Autor:
Michael Lahai, Laurie Lake, Ahmed Vandy, Bondu Sebba, Mohamed Sesay, Onome T. Abiri, Joy Johnson, Tamba Buffa, Abdulai Kanu, Mohamed Bawoh, James P. Komeh, Wiltshire C.N Johnson
Publikováno v:
BMC Health Services Research, Vol 24, Iss 1, Pp 1-9 (2024)
Abstract Background National Medicines Regulatory Authorities like the Pharmacy Board of Sierra Leone are responsible for protecting and promoting public health, implementing regulatory standards, and maintaining a supply chain with an assured supply
Externí odkaz:
https://doaj.org/article/96c97a51e7e340debf4c14f40958f1db
Autor:
Dhyuti Gupta, Prithpal Singh Matreja, Shilpa Patrick, Meenu Thomas, Pooja Agarwal, Preeti Singh
Publikováno v:
Drugs in Context, Vol 13, Pp 1-10 (2024)
Background: Fixed-dose combinations (FDCs) were brought into the market with the intent of providing benefits primarily to patients and physicians. Nevertheless, despite their multiple advantages, they have their own set of drawbacks, especially rega
Externí odkaz:
https://doaj.org/article/8ff47aef75a446e99ca7b8bcd7c9a313
Current Information on the Safety of Medicinal Products: Decisions of Foreign Regulatory Authorities
Autor:
E. V. Shubnikova
Publikováno v:
Безопасность и риск фармакотерапии, Vol 12, Iss 1, Pp 117-120 (2024)
The experts of the Department for Medicine Safety Evaluation of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of international pharmacovigilance regulatory authorities on the necessary labelling u
Externí odkaz:
https://doaj.org/article/21830f780d4147f99c7392f27797999a
Autor:
Alireza Khadem Broojerdi, Anna Laura Salvati, Mohammed Refaat Abdelfattah, Razieh Ostad Ali Dehaghi, Hiiti B. Sillo, Rogerio Gaspar
Publikováno v:
Frontiers in Medicine, Vol 11 (2024)
BackgroundIncreased global access to safe, effective and quality-assured medical products remains a primary goal for the full realization of the World Health Assembly Resolution WHA 67.20 on regulatory systems strengthening for medical products as we
Externí odkaz:
https://doaj.org/article/8976e2a52075414296b749f4f3b17e2b
Autor:
Frontiers Production Office
Publikováno v:
Frontiers in Medicine, Vol 11 (2024)
Externí odkaz:
https://doaj.org/article/9b1546b522754e6f9ef0a8dcb86bc34e
Publikováno v:
Frontiers in Medicine, Vol 11 (2024)
Medicine regulators need to judge whether a drug’s favorable effects outweigh its unfavorable effects based on a dossier submitted by an applicant, such as a pharmaceutical company. Because scientific knowledge is inherently uncertain, regulators a
Externí odkaz:
https://doaj.org/article/de5da8ddadff4f3eacf6cd06570a7d93
Autor:
Claudia P. Alfonso, Guy B. N’Jambong, Alaa Magdy, Laura Di Trapani, Rutendo Kuwana, Abraham G. Kahsay, Diadié Maïga, Sybil N. A. Ossei-Agyeman-Yeboah, Aimé B. Djitafo Fah, Margareth Ndomondo-Sigonda
Publikováno v:
Frontiers in Medicine, Vol 11 (2024)
BackgroundRegulatory systems strengthening is crucial for catalyzing access to safe and effective medical products and health technologies (MPHT) for all. Identifying and addressing common regulatory gaps through regional approaches could be instrume
Externí odkaz:
https://doaj.org/article/5bd9902bb9dc4a56a2ee0219714c2bdc