China
Africa
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Applications of RWE for Regulatory Uses
Published in Kelly H. Zou, Lobna A. Salem, Amrit Ray, Real-World Evidence in a Patient-Centric Digital Era, 2023
Eleanor E. Panico, Corinne S. Pillai, Ewa Filipowska, Kelly H. Zou
In the European Union (EU), similar regulations are in place to monitor a drug’s safety over time and the EMA Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring the safety of human medicines. The PRAC is made up of safety experts and regulatory authorities in the EU Member States as well as healthcare professionals nominated by the European Commission (Pharmacovigilance: Overview).
Bayesian Background
Published in Emmanuel Lesaffre, Gianluca Baio, Bruno Boulanger, Bayesian Methods in Pharmaceutical Research, 2020
Emmanuel Lesaffre, Gianluca Baio
Medical knowledge grows by setting up successive experiments to test theoretical conjectures about the mechanisms of action and the resulting effectiveness of healthcare interventions. Each result, whether a failure or a success, gives insight into the medical processes. This is the successful paradigm that pharmaceutical research has followed over many years. For instance, before drugs enter the market they undergo numerous tests from pre-clinical studies, Phase I studies, Phase II studies to Phase III studies. Even when approved and registered by regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), large scale studies are set up to evaluate the safety of the drugs. Nevertheless, despite this careful process of learning, the current process of accumulating knowledge has been criticized heavily since it turns out that much of the (medical) scientific results cannot be reproduced (Baker, 2011).
Manufacturing pollen and fungal extracts
Published in Richard F. Lockey, Dennis K. Ledford, Allergens and Allergen Immunotherapy, 2020
Robert E. Esch, Rosa Codina, Fernando Pineda, Ricardo Palacios
Because pollen and fungal raw materials are utilized to manufacture medicinal products for animal use, they are considered active pharmaceutical ingredients (APIs). APIs that are produced by chemical synthesis, extraction or recovery from natural products, cell culture or fermentation, recombinant DNA technology, or any combination of these processes are regulated by the U.S. Food and Drug Administration (FDA) and the Center for Biologics Evaluations and Research (CBER) in the United States [10]. The main regulatory agencies in Europe include the European Medicines Agency (EMA) in compliance with the European Pharmacopoeia (EP) [11,12], although other entities operate in particular countries.
Comparative assessment of myocarditis and pericarditis reporting rates related to mRNA COVID-19 vaccines in Europe and the United States
Published in Expert Review of Vaccines, 2022
Sophia Hatziantoniou, Cleo Anastassopoulou, George Lazaros, Konstantinos Vasileiou, Costas Tsioufis, Athanasios Tsakris
EudraVigilance is the system of the European Medicines Agency (EMA) for monitoring and analyzing suspected adverse reactions to medicines and vaccines reported from the EEA that includes 27 EU countries (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden) and also Iceland, Liechtenstein, and Norway [4]. VAERS, an early warning system comanaged by the Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC), records and analyzes possible adverse events postvaccination in the US [5]. Both EudraVigilance and VAERS are passive reporting systems where healthcare professionals, patients, and vaccine manufacturers can report adverse events. As such, both systems are subject to misreporting biases. Nonetheless, internal evaluation of reported adverse events, including detection and merging of duplicated cases, minimizes potential errors [4,5,10].
COVID-19 vaccine equity: a health systems and policy perspective
Published in Expert Review of Vaccines, 2022
Remco Van De Pas, Marc-Alain Widdowson, Raffaella Ravinetto, Prashanth N Srinivas, Theresa J. Ochoa, Thierno Oumar Fofana, Wim Van Damme
Effectiveness and safety; the WHO has a vaccine prequalification team that ensures that vaccines used in national immunization programs are safe and effective. As of May 2021, the WHO has approved six COVID-19 vaccines as safe and effective (an Emergency Use Listing, EUL), including the Sinopharm vaccine [84]. China has supplied over 100 million doses of the Sinovac and Sinopharm vaccines to 69 countries including Cambodia, Serbia, and Indonesia. More than 75 million of those doses have been delivered to 10 countries in Latin America [85]. With this WHO listing, Sinopharm vaccines likely become more dominant in LICs/LMICs. The emergence of new variants, especially the B.1.617 ‘double mutation’ one in India, raises questions on the efficacy of existing vaccines. The Sinovac vaccine has been reported to be only 56% effective against mild disease after two doses [86]. Continuous vaccine ‘rolling reviews’ of the safety and effectiveness of COVID-19 vaccines are crucial. While in Europe, the European Medicines Agency takes this role, such a regulatory agency will have to be strengthened for the regional manufacturing hubs in Africa. Capacity development and a governance structure to do so need to be developed in close collaboration with the AU, the African CDC, and the, to be established, African Medicines Agency (AMA) [87].
Thiamine administration to all patients with alcohol use disorder: why not?
Published in The American Journal of Drug and Alcohol Abuse, 2021
Roberta Agabio, Lorenzo Leggio
The results from Peck et al. (13) also reflect a larger issue. That is, patients with AUD and those with other substance use disorders often do not receive proper or state-of-the-art treatment for their substance use disorder. For example, we have effective medications for AUD (i.e., acamprosate, disulfiram, and naltrexone) which are approved by the regulatory agencies like the Food and Drug Administration and European Medicines Agency (19). These medications may help patients reduce alcohol consumption, and thereby decrease the related risk of mortality (20). Yet, these medications are significantly underutilized even though the risk of mortality for patients with AUD is 3 to 4 times higher than general population (21). Of note, the overall rate of thiamine administration in patients with AUD or alcohol misuse, described in the present study by Peck and colleagues (13) was 2.2%, a rate very similar to that of patients who receive medications approved for AUD in the US, for example, 1.6% in a recent report by Han and colleagues (22). Such low prescriptions rates of gold-standard treatments would be unthinkable and unacceptable for other chronic health conditions such as hypertension, diabetes, or hypothyroidism, just to name a few. Reasons that contribute to this issue include the lack of enough well-trained physicians and other health care providers with expertise in addiction (23) and the stigma around AUD, substance use disorders and mental illness (24).