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New Governmental Regulatory System for Stem Cell—Based Therapies in Japan
Regenerative medicine using stem cells is expected to provide tools for the replacement or repair of damaged tissues, opening up the possibility of...
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Ökonomische Aspekte des deutschen Arzneimittelmarktes 2014
Der GKV-Fertigarzneimittelumsatz ist im Jahr 2014 mit 33,6 Mrd. € gegenüber dem Vorjahr um 6,5% angestiegen. Ebenfalls angestiegen sind die...
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Product Registration in Develo** Countries: A Proposal for an Integrated Regional Licensing System Among Countries in Regional Economic Blocs
The product pipeline for diseases that disproportionately affect the develo** world has considerably expanded over the last decade. Indeed, there...
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Drei Jahre frühe Nutzenbewertung nach §35a SGB V – kritische Würdigung und Lösungsvorschlag
BackgroundAgainst the background of increasing cost pressure in the German Health Care system German health policy introduced several law changes to...
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Consideration of Factors Affecting the Safety Index in Early Clinical Drug Development
In drug development, a safety index—the ratio of the highest exposure that does not induce toxicity to the exposure that exerts efficacy—is used to...
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AMNOG – Erste Erfahrungen und mögliche Auswirkungen auf die Klinische Forschung
Background and ObjectiveOn January 1st 2012 the German Law for Reforming the Market for Pharmaceuticals ( Arzneimittelverordnungsgesetz: AMNOG ) came...
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Investigation of the Safety Profiles of Japanese Clinical Trials
BackgroundThe increasing attrition rates of new drug research and development have become a global problem. To tackle this problem as well as the...
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Investigation of Characteristics of Japanese Clinical Trials in Terms of Data Variability
BackgroundBecause Asian countries have become involved in multiregional clinical trials, it is increasingly important to understand the...
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An in-depth analysis of pharmaceutical regulation in the Republic of Moldova
ObjectiveRegulation of the pharmaceutical system is a crucial, yet often neglected, component in ensuring access to safe and effective medicines. The...
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A Review of Regulatory Mechanisms Used by the WHO, EU, and US to Facilitate Access to Quality Medicinal Products in Develo** Countries With Constrained Regulatory Capacities
Adequate medicine regulation requires nations to establish robust regulatory agencies that will subject all pharmaceutical products to pre- and...
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Training New-Hire Medical Information Specialists in the Pharmaceutical Industry: A Benchmarking Survey
Most pharmaceutical and biotechnology companies have a medical information (MI) department staffed by medical information specialists (MISs); to...
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Hybrid or Mixed Marketing Authorization Application in the European Union: Not a Trivial Decision in New Development Programs for Established Drugs
For any medicinal product Marketing Authorization Application (MAA) in the European Union, the applicant needs to indicate the legal basis for the...
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Collaboration and Convergence: Bringing New Medicines to Global Markets in the 21st Century
In the coming years, the drug development process is likely to change dramatically as manufacturers, regulators, and payers across the world face...
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Arzneiverordnungen 2012 im Überblick
Die Arzneimittelausgaben der Gesetzlichen Krankenversicherung (GKV) sind nach dem vorjährigen Rückgang 2012 wieder leicht angestiegen. Der Zuwachs...
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Development and Application of Scorecards to Assess the Quality of a Regulatory Submission and Its Review
An efficient review depends not only on timely approval but also on ensuring the qualityof the processfrom construction of the dossier to the...
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Regulatory Review Process in the Gulf Cooperation Council States: Similarities and Differences
This study compared the assessment models and the regulatory review processes conducted in the Gulf Cooperation Council (GCC) region. A questionnaire...
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Nutzenbewertung von Arzneimitteln
Mit dem Inkrafttreten des Arzneimittelmarkt-Neuordnungsgesetzes (AMNOG) am 1. Januar 2011 wurde eine jahrzehntelange Sonderstellung des deutschen...
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Providing Medical Information for Orphan Drugs
Medical information departments are responsible for providing information regarding the drugs the company manufactures and the diseases these drugs...
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An Appraisal of Good Regulatory Review Practices in the Gulf Cooperation Council States
The aim of this study was to evaluate how each Gulf Cooperation Council (GCC) regulatory authority is building quality into the assessment and...