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Monitoring medical research: Better to prevent than to cure?
Published in Frank Wells, Michael Farthing, Fraud and Misconduct in Biomedical Research, 2019
Ideally, any situations where, on the grounds of inadequate efficacy or safety, products should be suspended or withdrawn should be avoided, as these products have already resulted in harm to patients and created public distrust in the medical profession and pharmaceutical industry. However, it is implicit in the standard process of drug development that such problems are frequently only detected after a large population of patients has been exposed to the drug. At present, owing to increasing drug development costs (resulting in high medicine costs and hence high health-care costs), there is very considerable pressure (not only from the industry, but also from patient groups as well as authorities themselves) towards faster drug development processes. That is why more and more emphasis is being put on the need for the implementation of a proactive, effective pharmacovigilance system by the marketing authorization holder. In addition, pharmacovigilance monitoring by the licensing authorities has been strengthened by the introduction of additional guidance and regulations, such as the new Volume 9A of the rules governing medicinal products in the European Union (EU), EudraLex (www.ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev9.htm).4 As a result of these pressures, there has been an enormous increase in pharmacovigilance inspection activities.
Annexures
Published in Amritpal Singh Saroya, Contemporary Phytomedicines, 2017
The following guidance is for applicants to the traditional herbal medicinal products registration scheme on the format and content of applications. Applicants also should ensure that they are familiar with the relevant EU legislation and guidelines published for human medicines including:Directive 2001/83/EC, as amended by 2004/24/EC and 2004/27/EC available on the European Commission website.EUDRALEX Volume 2—Pharmaceutical Legislation : Notice to Applicants available on the European Commission website.
Advances in stem cell therapy for amyotrophic lateral sclerosis
Published in Expert Opinion on Biological Therapy, 2018
Letizia Mazzini, Daniela Ferrari, Pavle R Andjus, Leonora Buzanska, Roberto Cantello, Fabiola De Marchi, Maurizio Gelati, Rashid Giniatullin, Joel C. Glover, Mariagrazia Grilli, Elena N. Kozlova, Margherita Maioli, Dinko Mitrečić, Augustas Pivoriunas, Rosario Sanchez-Pernaute, Anna Sarnowska, Angelo L. Vescovi
In the past decade, genes, cells, and engineered tissues have been extensively studied as potential new therapeutic tools in Europe and worldwide for many different diseases, particularly neurodegenerative diseases. These innovative products were collectively defined as Advanced Therapies Medicinal Products (ATMP) according to the European Directive 2001/83/EC [133], amended by Commission Directive 2009/120/EC [134]. Complex therapeutic products such as ATMPs require a precise legal definition. Each of these products should possess specific pharmacological, metabolic, and immunological activities. For these reasons, ATMPs, prepared on a routine basis, must meet the same stringent conditions required for ‘traditional’ drugs before they are used on patients or placed on the market. Their activity, efficacy, safety, and required dose must be defined. Furthermore, they must be produced according to Good Manufacturing Practice (GMP), tested preclinically according to Good Laboratory Practice (GLP), and clinical trials must be conducted according to Good Clinical Practice (GCP) (Eudralex see applicable EU legislation [135]. Regulation (EU) No 536/2014 [136] on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC [137].
Analgesic effects of dexmedetomidine and remifentanil on periprocedural pain during percutaneous ablation of renal carcinoma
Published in Upsala Journal of Medical Sciences, 2020
Egidijus Semenas, Maria Lönnemark, Pär Dahlman, Michael Hultström, Mats Eriksson
Fifty-one patients planned for percutaneous ablation of renal carcinoma were screened for participation in this study. All patients gave their oral and written consent to participate in this study, which was approved (2013/409) by the Regional Ethical Review Board at Uppsala University, Sweden. According to Eudralex, we do not see this study as a clinical trial, which would need approval by the Swedish Medical Products Agency. This study was registered at Clinicaltrials.gov on December 13, 2013.
Assessing the adoption of clinical trial results summary disclosure to patients and the public
Published in Expert Review of Clinical Pharmacology, 2019
Ken Getz, Julia Farides-Mitchell
The European Commission established the European Clinical Trials Database (EuDRACT) in 2001. But, it wasn’t until 2012 that the Commission issued Eudralex Volume 10 Guideline 2012/C 302/03 which required technical results summaries for all clinical trials conducted by at least one European Member state to be posted on the EUDRACT databank (https://eudract.ema.europa.eu/) within one year after completion.