In Europe, new medicines are approved or rejected on the basis of the results of studies carried out by the manufacturer and submitted to the European Medicines Agency (EMA). This article briefly presents the main roles and responsibilities of the EMA and the key rules that govern the approval process. The main scientific limitations of this process are highlighted, together with some suggestions for dealing with them
This paper is aimed at examining the European medicine agency decisions in the field of human medici...
The European Medicines Agency (EMA) is a European Agency as it is a decentralized body governed by E...
medications it considers for ap-proval.1 After the marketing autho-rization process is complete, re-...
In Europe, new medicines are approved or rejected on the basis of the results of studies carried out...
Since 2005 all new glucose‐lowering medicines to be used in Europe have required approval by the Eur...
Corrado Barbui and Irene Bighelli question the current rules governing registration of new medicines...
The relevance of continuous development of new medicines is publicly recognized, but the development...
INTRODUCTION: The efficacy of pharmaceuticals is most often demonstrated by randomised controlled tr...
The European Medicines Agency (EMA) is responsible for the scientific evaluation of medicines develo...
The authors thank the observers of the PKWP who have supported the development of the PSBGL and also...
BACKGROUND: The European Medicines Agency (EMA) aims to resolve uncertainties associated with condit...
Abstract We aimed to evaluate the quality of clinical evidence that substantiated approval of cancer...
Following a review process lasting almost four years, and culminating in several pieces of new Europ...
Background: Non-inferiority trials are associated with methodological challenges. The European Medic...
Following a review process lasting almost four years, and culminating in several pieces of new Europ...
This paper is aimed at examining the European medicine agency decisions in the field of human medici...
The European Medicines Agency (EMA) is a European Agency as it is a decentralized body governed by E...
medications it considers for ap-proval.1 After the marketing autho-rization process is complete, re-...
In Europe, new medicines are approved or rejected on the basis of the results of studies carried out...
Since 2005 all new glucose‐lowering medicines to be used in Europe have required approval by the Eur...
Corrado Barbui and Irene Bighelli question the current rules governing registration of new medicines...
The relevance of continuous development of new medicines is publicly recognized, but the development...
INTRODUCTION: The efficacy of pharmaceuticals is most often demonstrated by randomised controlled tr...
The European Medicines Agency (EMA) is responsible for the scientific evaluation of medicines develo...
The authors thank the observers of the PKWP who have supported the development of the PSBGL and also...
BACKGROUND: The European Medicines Agency (EMA) aims to resolve uncertainties associated with condit...
Abstract We aimed to evaluate the quality of clinical evidence that substantiated approval of cancer...
Following a review process lasting almost four years, and culminating in several pieces of new Europ...
Background: Non-inferiority trials are associated with methodological challenges. The European Medic...
Following a review process lasting almost four years, and culminating in several pieces of new Europ...
This paper is aimed at examining the European medicine agency decisions in the field of human medici...
The European Medicines Agency (EMA) is a European Agency as it is a decentralized body governed by E...
medications it considers for ap-proval.1 After the marketing autho-rization process is complete, re-...
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