Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm

Bonn, Germany

Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm

Bonn, Germany
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Isaac M.,European Medicines Agency EMEA | Isaac M.,King's College London | Koch A.,European Medicines Agency EMEA | Koch A.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm | Koch A.,Hannover Medical School
European Neuropsychopharmacology | Year: 2010

In this paper we investigate mortality in short-term placebo-controlled trials conducted to demonstrate efficacy and safety of atypical antipsychotic drugs for the treatment of schizophrenic patients in the acute phase of illness. Arguments are provided, why short-term placebo-controlled studies are required. This is an integrated analysis of results from randomized placebo-controlled trials conducted pre-licensing for risperidone, olanzapine, quetiapine IR, ziprasidone, risperidone consta, aripiprazole, paliperidone, and quetiapine XR. Information was retrieved from study publications, EPAR, and from the FDA SBA, all in the public domain. 7553 patients were randomized in the remaining 23 short-term acute phase clinical trials. 2/5738 patients died after having been randomized to an active treatment. 5/1815 died in the placebo group. The crude odds-ratio for an increased death risk with placebo treatment is 7.92 (95% confidence interval (1.45 to 40.87), two sided P = 0.0134). Death narratives show: (i) both deaths in active treatment groups occurred during randomized treatment period, (ii) two deaths in the placebo group of a trial in the elderly were observed in patients with severe co-morbidities not usually included in a randomized trial, and (iii) two further deaths in the placebo groups occurred 9 and 23 days after the end of the randomized treatment period. Under these circumstances the crude odds-ratio for an increased risk of death for patient with placebo as compared to active treatment is 1.58 (95% confidence interval (0.14-17.45), two sided P = 0.71). Confidence intervals are generally wide indicating a still limited knowledge about a potential increase in mortality with placebo treatment. Unless, however, society is willing to take the risk that ineffective drugs are licensed and cause undetected harm thereafter, or is willing to restrict licensing to drugs that are superior to current treatments, short-term placebo-controlled trials in the acute phase of schizophrenia are necessary. Measures are proposed to minimize risks. © 2010 Elsevier B.V. and ECNP.


Crommelin D.J.A.,University Utrecht | Broich K.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm | Holloway C.,Chief Scientific Officer of ERA Consulting GmbH | Meesen B.,Ismar Healthcare | And 3 more authors.
Multiple Sclerosis | Year: 2016

Background: Although there is still no cure for multiple sclerosis (MS), the introduction of several innovative drugs with modes of action different from that of the existing drug arsenal and the progress in monitoring disease progression by imaging and using biomarkers are currently causing a knowledge surge. This provides opportunities for improving patient disease management. New therapies are also under development and pose challenges to the regulatory bodies regarding the optimal design of clinical trials with more patient-focused clinical endpoints. Moreover, with the upcoming patent expiry of some of the key first-line MS treatments in Europe, regulatory bodies will also face the challenge of recommending marketing authorisation for generic and abridged versions based on appropriate requirements for demonstrating equality/similarity to the innovator's product. Objective: The goal of this article is to improve the understanding of the relevant guidance documents of the European Medicines Agency (EMA) on clinical investigation of medicinal products and to highlight the issues that the agency will need to clarify regarding follow-on products of first-line MS treatments. Conclusion: Today, it is clear that close collaboration between patients, healthcare professionals, regulatory bodies and industry is crucial for developing new safe and effective drugs, which satisfy the needs of MS patients. © SAGE Publications.


Afentaki A.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm | Afentaki A.,University of Duisburg - Essen
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz | Year: 2014

Regulation EC 1901/2006, better known as the "Paediatric Regulation," targets the challenging aim of improving the supply of pharmaceutical products for children and adolescents living in Europe. In order to counteract the much-debated and long-standing problem of "off-label" use within paediatrics, the Paediatric Regulation established two new paediatric procedures in order to increase the number of medicines licensed for children in future. This article reports on the outcomes of these procedures, covering the period from 2007 to the present. The aim was to find out how many substances underwent the paediatric procedures and how many medicinal products have been approved explicitly for children as a result. In the second part, a prioritized off-label analysis was conducted focusing on the top 100 substances most frequently prescribed to children and adolescents in Germany in 2011. The top 100 substances consist of the respective top 20 substances of five therapeutic areas. The prescription scores are based on the GAmSi project of the National Association of the Statutory Health Insurance of Germany. The rankings refer to outpatient care and cover the statutory health-insured paediatric population of Germany below 18 years of age, divided into two age groups, children and adolescents. In order to investigate whether the most frequently prescribed substances are labelled for paediatric use, 200 SmPCs were screened and evaluated (cut-off date: 31 December 2012). In a final step, the relation between the top 100 substances and the Paediatric Regulation was examined. For this purpose, it was investigated whether the listed substances are or have been subject to the paediatric procedures in order to identify potential positive impacts of the Paediatric Regulation. © 2014 Springer-Verlag Berlin Heidelberg.


Freudenberger T.,University of Duisburg - Essen | Oppermann M.,Heinrich Heine University Düsseldorf | Heim H.-K.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm | Mayer P.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm | And 3 more authors.
Basic Research in Cardiology | Year: 2010

Clinical studies revealed unfavorable effects of hormone replacement therapy in postmenopausal women despite strong evidence for vasoprotective effects of estrogen in animal models. Therefore, an attempt was made to address adverse effects of estradiol on atherosclerosis, endothelial function, and thrombosis in a murine model of atherosclerosis. ApoE-/- mice were bilaterally ovariectomized (OVX) and substituted with placebo or 17-β-Estradiol (E2, 1.1 and 6.6 μg/day) on Western diet for 90 days. Low-dose E2 (1.1 μg/day) treatment significantly increased atherosclerotic plaque score, whereas high-dose E2 (6.6 μg/ day) reduced aortic plaque burden. The proatherosclerotic effects of low-dose E2 were associated with decreased total collagen in aortic root lesions and impaired acetylcholine (ACh)-induced vasorelaxation of aortic rings. On the contrary, OVX compared with control reduced atherosclerosis, increased fibrillar collagen and improved endothelial function. The thrombotic response as measured in a photothrombosis model was not significantly altered by E 2 or OVX. Taken together, differential effects on atherosclerosis of the clinical relevant low-dose E2 compared with high-dose E 2 were demonstrated. Importantly, the presented experimental conditions provide a model to study the untoward vascular effects of E 2 in the context of accelerated and advanced atherosclerosis. © Springer-Verlag 2010.


Weiergraber M.,Bundesinstitut For Arzneimit Tel Und Medizinprodukte Bfarm | Broich K.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm
Psychopharmakotherapie | Year: 2011

Neuroenhancement, mood enhancement and mind-doping are part of a complex social development of the 21st century, demanding for a careful and integrative medicinal discussion. The goal of this overview is to illustrate the various aspects of mind-doping, its medical history, epidemiology, the underlying motivations, the neurophysiological background and pharmacological and regulatory issues related to active substances involved. A specific focus is put on the ethical implications of neuro- and mood enhancement. The pros and cons of mind-doping need to be balanced carefully and a social consensus is clearly inevitable for a responsible handling of cognitive and mood enhancers in the future.


Wiesner J.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm | Knoss W.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm
Zeitschrift fur Phytotherapie | Year: 2010

Summary Tests on genotoxicity for herbal medicinal products. Demands, pragmatic attempts, and discussions With respect to the common medicinal and traditional use of herbal medicinal products, there is a possibility to reduce the set of tests to be performed in the context of preclinical testing. This is especially the case for tests on genotoxicity, although it does not replace a critical discussion of the relevant data. Consideration of the particulars of herbal medicinal products does not only offer the chance to reduce the testing adequately but also provokes some additional questions which should be addressed case by case. There is an inevitable gap between regulatory requirements and sound experimental methodology. It is a major task of the preclinical expert report to bridge this gap by means of a qualified discussion and interpretation of the available data.


An integral part of the conformity assessment process for medical devices is a clinical evaluation based on clinical data. Particularly in the case of implantable devices and products of risk class III clinical trials must be performed. Since March 2010 applications for the authorization of clinical trials as well as for the waiver of the authorization requirement must be submitted centrally in Germany to the appropriate federal authority, the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI). In addition to authorization, approval by the responsible ethics committee is also required under law in order to begin clinical testing of medical devices in Germany. In this paper, the legal framework for the clinical testing of medical devices as well as those involved and possible procedures including evaluation criteria for the initial application of a trial and subsequent amendments are presented in detail. In addition, the reporting requirements for serious adverse events (SAEs) are explained and possible consequences of the evaluation are presented. Finally, a summary of application and registration numbers for all areas of extensive experience of the BfArM as well as requests and guidance for applicants are presented. © 2014, Springer-Verlag Berlin Heidelberg.


Norwig J.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz | Year: 2014

According to the EU Directive 2001/83 the European Pharmacopoeia is the official Pharmacopoeia of the European Union. Therefore the European Pharmacopoeia is one of the legal pharmacopoeial compendia in Germany. Any licensed medicinal product on the German market complies with the requirements of the compendial monographs, if applicable. Because the general monographs of the European Pharmacopoeia on Dosage Forms, Substances for Pharmaceutical Use and Pharmaceutical Preparations refer to the microbiological and biological methods of the Pharmacopoeia, the methods are relevant for medicinal products, too. This article presents a rough summary of the microbiological and biological methods of the European Pharmacopoeia and is intended to be a stimulus for the reader to better understand the original compendia. The short description of the methods mentioned, here, is a summary from the Pharmacopoeia and the non-official collection of comments on the texts of the European Pharmacopoeia. © 2014, Springer-Verlag Berlin Heidelberg.


Lauer W.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm | Stosslein E.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm | Brinker A.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm | Broich K.,Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz | Year: 2014

Medical devices are of great importance for the prevention, diagnosis and treatment of many diseases. With their broad range and interdisciplinarity, they represent both a very dynamic field of innovation and a significant sector of the economy. The European and thus the German Medical Devices Act aim in this context to make new medical devices for patients and users rapidly available while ensuring safety and performance at the same time. The main responsibility for this lies with the manufacturer. In addition, others are involved in a complex collaboration in the conformity assessment and also later in the marketing phase for the early identification, assessment and minimization of potential risks. This paper presents the legal framework for medical devices and the related roles and responsibilities of various stakeholders, especially the two federal agencies the German Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI). From the perspective of the BfArM the procedure and criteria for risk assessment of incident reports are explained and the experiences and wishes from regulatory practice are described. The active engagement of the BfArM to contribute knowledge from the incident report assessment within the relevant standards organisations and the medical profession is described using examples of medical devices from the field of out-of-hospital ventilation. The paper concludes with a look at future challenges, e.g. in combination products, IT networks and automatization, as well as on current developments to improve risk identification and assessment in a European context. © 2014, Springer-Verlag Berlin Heidelberg.


PubMed | Bundesinstitut For Arzneimittel Und Medizinprodukte Bfarm
Type: | Journal: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz | Year: 2017

Because of the growing healthcare market and the increasing health consciousness of the population, more and more food supplements are being placed on the market in addition to medicinal products. Concerning the demarcation of medicinal products to food supplements, not only is the intended purpose of the product critical, but the mode of action of the respective preparation also plays an important role. Following the legal definition, adrug has apharmacological effect, without it being further defined. Therefore, many courts have already tried to interpret the term pharmacological effect, including the terms metabolic or immunologic effect, and try to describe this in more detail.It should be noted that the pharmacological effect, which means an interaction of the substance of amedicinal product with cellular constituent of the human body - unlike the effect of afoodstuff - must significantly affect the physiological functions and must therefore exert targeted effects on the human body and its functions, more than with the consumption of aconventional quantity of afood would be possible. These modifying physiological functions of the body must be addressed positively, which means beneficial to human health. Products which are consumed only for euphoria purposes, or even have aharmful effect, shall not be classified as medicinal products, despite their pharmacological mechanism of action.

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