EU Clinical Trials Regulation 2014: Fetter or facilitator?

Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use: an overview.

For the 28 member states of the European Union, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, which repeals Directive 2001/20/EC, represents a substantial innovation in the procedures for authorising clinical trials and for handling all the subsequent stages. It introduces a single authorisation that will be valid for all EU member states, as well as a sing...

Harmful impact of EU clinical trials directive.

Mycobacterium tuberculosis: 2014 Clinical trials in review

Tuberculosis (TB) is a major cause of death and suffering worldwide. Based on data from the WHO, an estimated nine million new cases were diagnosed in 2013, with 1.5 million associated deaths (1.1 million HIV-negative cases and 0.36 million HIV-positive cases) (1). Worldwide incidence and mortality rates have been declining over the past decade due to enhanced diagnosis and management of both T...

TCM Zheng Classification and Clinical Trials 2014

In continuation of the last year's special issue " TCM Zheng Classification and Clinical Trials, " the time for 2014 issue has come. Now we are on the way from TCM Zheng classification in clinical trial to development of clinical practice guideline. Clinical effectiveness is what matters most in any treatment, including traditional Chinese medicine (TCM). Many clinical trials have been conducte...

Input analysis for two public consultations on the EU Clinical Trials Regulation

BACKGROUND The European Union's (EU) Clinical Trials Directive was replaced by an EU-Regulation as of 2016. The policy revision process was subject to a formal impact assessment exercised by the European Commission (EC) from 2008 to 2014. Following the EU principles of Good Governance, deliberation with stakeholders was an integral part of this impact assessment and the policy formulation proce...