scholarly journals Roles and Rules of Some Regulatory Agencies around the World during COVID-19 Pandemic

2021 ◽  
pp. 178-187
Author(s):  
Aseel Bin Sawad ◽  
Fatema Turkistani
Keyword(s):  
Drug Administration ◽  
Medical Devices ◽  
Regulatory Agencies ◽  
European Medicines Agency ◽  
Cure Models ◽  
The Us ◽  
The World ◽  
Us Fda ◽  
Health Canada ◽  
Official Sources

Objective: Collecting and synthesizing relevant data on COVID-19 from official sources of some different regulatory agencies around the world. Methods: The information and actions related to responding to the COVID-19 situation were collected from the websites of some regulatory agencies, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada (HC), Swiss Agency for Therapeutic Products (Swissmedic), and the Australian Therapeutic Goods Administration (TGA). Results: All the regulatory agencies help in expediting the development of COVID-19 treatments and medical devices. These agencies also developed an international regulatory collaboration to develop cure models for the pandemic. While some of the agencies conduct the COVID-19 testing, like the US FDA, the others do not. The agencies also differ in their approaches towards resolving the pandemic. FDA and EMA are more aggressive in a way that they prioritize more testing and hospitalization coverage. However, as of the 22nd of June 2021, the FDA authorized the highest number (388) of diagnostic COVID-19 test kits followed by TGA (128), and EMA (88). Conclusions: Although the regulatory agencies differ in their approaches towards resolving pandemic COVID-19, all regulatory agencies help in expediting the development of COVID-19 treatments and medical devices.

scholarly journals Comparative study of updated Clinical Trial Regulations in India with respect to Australia, Europe, Japan and US

2021 ◽  
Vol 9 (1) ◽  
pp. 48-61
Author(s):  
Devender Kumar ◽  
Shivali Rahi ◽  
Arpana Rana
Keyword(s):  
Clinical Trial ◽  
Medical Devices ◽  
Pharmaceutical Products ◽  
European Medicines Agency ◽  
Pharmaceutical Companies ◽  
Drug Candidates ◽  
Geographical Regions ◽  
The Us ◽  
The World ◽  
Scientific Standards

The national regulatory authorities, such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Central Drugs Standard Control Organization and the Australian Therapeutic Goods Administration (TGA), approve every drug that is prescribed for patients around the world. The process of approval undertaken by pharmaceutical companies for drug candidates consists of a series of phases to ensure the product is safe and effective at treating the disease. In this paper, we will compare the clinical trial regulations of India with respect to Australia, Europe, Japan & USA in order to determine the safety and efficacy of pharmaceutical products like drugs, biologics and medical devices in different geographical regions and to confirm the clinical trials studies follow strict scientific standards.

scholarly journals The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA

Pharmaceutics ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 48
Author(s):  
Ioana Gherghescu ◽  
M. Begoña Delgado-Charro
Keyword(s):  
Drug Administration ◽  
Action Plan ◽  
European Medicines Agency ◽  
Patient Access ◽  
Clinical Evaluations ◽  
The Past ◽  
The Us ◽  
Improve Patient ◽  
The Eu

Biosimilar medicines expand the biotherapeutic market and improve patient access. This work looked into the landscape of the European and US biosimilar products, their regulatory authorization, market availability, and clinical evaluation undergone prior to the regulatory approval. European Medicines Agency (EMEA, currently EMA) and Food and Drug Administration (FDA) repositories were searched to identify all biosimilar medicines approved before December 2019. Adalimumab biosimilars, and particularly their clinical evaluations, were used as a case study. In the past 13 years, the EMA has received 65 marketing authorization applications for biosimilar medicines with 55 approved biosimilars available in the EU market. Since the first biosimilar approval in 2015, the FDA has granted 26 approvals for biosimilars with only 11 being currently on the US market. Five adalimumab biosimilars have been approved in the EU and commercialized as eight different medicines through duplicate marketing authorizations. Whilst three of these are FDA-approved, the first adalimumab biosimilar will not be marketed in the US until 2023 due to Humira’s exclusivity period. The EU biosimilar market has developed faster than its US counterpart, as the latter is probably challenged by a series of patents and exclusivity periods protecting the bio-originator medicines, an issue addressed by the US’s latest ‘Biosimilar Action Plan’.

Letters to the Editor

PEDIATRICS ◽  
1981 ◽  
Vol 68 (3) ◽  
pp. 473-473
Author(s):  
David B. Nelson ◽  
Renate D. Kimbrough ◽  
Philip S. Landrigan ◽  
A. Wallace Hayes ◽  
George C. Yang ◽  
...  
Keyword(s):  
United States ◽  
Drug Administration ◽  
Food Supply ◽  
Food Industry ◽  
The United States ◽  
Letters To The Editor ◽  
Department Of Agriculture ◽  
The Us ◽  
The World ◽  
Food Commodities

Dr Wray's comments are, of course, very appropriate and encouraging. Aflatoxin was first detected in food commodities from other parts of the world. As concentrations in other parts of the world have usually been higher, little attention has been paid to the possibility of aflatoxin exposure in humans in the United States except by those who are directly involved in monitoring the human food supply (US Department of Agriculture, the food industry, and the US Food and Drug Administration).

scholarly journals UHPLC–MS/MS method for iohexol determination in human EDTA and lithium-heparin plasma, human urine and in goat- and pig EDTA plasma

Bioanalysis ◽  
2020 ◽  
Vol 12 (14) ◽  
pp. 981-990
Author(s):  
Jasper Stevens ◽  
Mireille A Wessels ◽  
Jan Roggeveld ◽  
Remco A Koster ◽  
Claire CJ Dekkers ◽  
...  
Keyword(s):  
Human Urine ◽  
Pharmacokinetic Profile ◽  
European Medicines Agency ◽  
Simple Method ◽  
The Us ◽  
Heparin Plasma ◽  
Thermo Fisher Scientific ◽  
Tandem Quadrupole Mass Spectrometer ◽  
Edta Plasma ◽  
Us Fda

Aim: Iohexol plasma clearance is used as an indicator of kidney function in clinical and preclinical settings. To investigate the pharmacokinetic profile of iohexol, a rapid, simple method for measurement of iohexol in different matrices and species was needed. Materials & methods: Iohexol was separated on an Accucore C18 column (Thermo Fisher Scientific, CA, USA). Detection was performed on a Thermo Scientific Quantiva tandem quadrupole mass spectrometer. The method was validated according to the requirements for bioanalytical methods issued by the US FDA and European Medicines Agency. Conclusion: We developed and validated a fast and efficient analytical method, suitable for analyzing iohexol in human EDTA plasma, human lithium-heparin plasma, human urine and goat- and pig EDTA plasma, using only one calibration line prepared in human EDTA plasma.

scholarly journals Almost half of references in reports on new and emerging nondrug health technologies are grey literature

2019 ◽  
Vol 107 (1) ◽  
Author(s):  
Kelly Farrah ◽  
Monika Mierzwinski-Urban
Keyword(s):  
Medical Devices ◽  
Laboratory Tests ◽  
Evidence Synthesis ◽  
Grey Literature ◽  
Regulatory Agencies ◽  
Literature Searching ◽  
Health Technologies ◽  
Clinical Trial Registries ◽  
Horizon Scanning ◽  
The Us

Objective: The research investigated how frequently grey literature is used in reports on new and emerging nondrug health technologies, which sources are most cited, and how grey literature searching is reported.Methods: A retrospective review of references cited in horizon scanning reports on nondrug health technologies—including medical devices, laboratory tests, and procedures—was conducted. A quasi-random sample of up to three reports per agency was selected from a compilation of reports published in 2014 by international horizon scanning services and health organizations.Results: Twenty-two reports from 8 agencies were included in the analysis. On average, 47% (288/617) of references listed in the bibliographies of the horizon scanning reports were grey literature. The most frequently cited type of grey literature was information from manufacturers (30% of all grey literature references), regulatory agencies (10%), clinical trial registries (9%), and other horizon scans or evidence synthesis reports (9%). The US Food and Drug Administration (FDA) and ClincalTrials.gov were the most frequently cited specific sources, constituting 7% and 8% of grey literature references, respectively. Over two-thirds (15/22) of the analyzed reports provided some details on search methodology; all 15 of these reported searching some grey literature.Conclusions: In this sample, grey literature represented almost half of the references cited in reports on new and emerging nondrug health technologies. Of these grey literature references, almost half came from three sources: the manufacturers, ClinicalTrials.gov, and the FDA. There was wide variation in the other sources cited. Literature search methodology was often insufficiently reported for analysis.

scholarly journals Structural and Functional Characterization of Low-molecular-weight Heparins: Impact on the Development of Guidelines for Generic Products

2009 ◽  
Vol 15 (2) ◽  
pp. 137-144 ◽  
Author(s):  
Cafer Adiguzel ◽  
Walter P. Jeske ◽  
Debra Hoppensteadt ◽  
Jeanine M. Walenga ◽  
Vinod Bansal ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Functional Characterization ◽  
Current Data ◽  
European Medicines Agency ◽  
Low Molecular Weight ◽  
Low Molecular Weight Heparins ◽  
Biological Drugs ◽  
Biologic Drugs ◽  
The Us ◽  
Us Fda

Low-molecular-weight heparins (LMWHs) are poly-pharmacologic drugs used to treat thrombotic and cardiovascular disorders. Recently, several generic versions of branded LMWHs have been introduced. Although generic versions of LMWHs exhibit similar profiles, marked differences in their biological and pharmacologic properties have been demonstrated. Several studies have demonstrated differences in terms of anti-Xa activity and tissue factor pathway inhibitor release. The current data emphasize the need to consider multiple functional parameters when defining bioequivalence of biologic drugs and also underscore the importance of further pharmacologic studies involving animal and human clinical trials. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are currently developing guidelines for the acceptance of complex biological drugs including LMWHs. The US FDA considers these drugs as follow-on agents whereas the EMEA classifies these drugs as biosimilar agents. Until clear guidelines are developed, generic interchange of LMWHs may not be feasible.

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