Sentence examples for application for marketing authorization from inspiring English sources

These increases were also admitted by Eli Lilly Industries in their application for marketing authorization in the European Community.

Phase IIIA is conducted prior to application for marketing authorization, while phase IIIB is conducted after application.

Therefore, a regulatory framework is in place in, for example, the European Union to assess the application for marketing authorization of biosimilars.

At the end of the clinical trials, provided the results are satisfactory, an application for marketing authorization can be submitted to the NRA.

Completion of phase 3 marks the accumulation of clinical experience used to prepare an application for marketing authorization by a regulatory agency such as the Food and Drug Administration FDAA) or European Medicines Agency EMAA).

Despite the increasing number of applications for marketing authorization in Europe, the proportion of applications with a negative decision remains relatively high, around 25 30%, and was even 40% for new active substances with a resolved outcome in 2009 [ 1] [ 2].

In addition, researchers must release a full clinical study report which contains detailed information about the trial design and analysis, including patient-level data sets if the medicine is submitted for marketing authorization, irrespective of that application's success.

This study was conducted to provide support for marketing authorization of this drug in China.

Surrogate endpoints are biomarkers that are intended to substitute for a clinical endpoint and support approval for marketing authorization.

The fact that the described FDOPA production is GMP compliant, our institute was granted an exemption to have a marketing authorization by the government to distribute FDOPA to other hospitals without a dossier for marketing authorization.

GMP guidelines represent minimal standards that are a necessary condition for marketing authorization.