There are a significant number of eligibility criteria that refer to previous administration of a study agent or to the authorisation status of products that have been previously administered, which includes use of an authorised medication outside of its approved indications.
The overall policy objective with the new Regulation is to improve the health of the children of Europe by increasing the research, development and authorisation of medicinal products for use in children.
The objective of this study was to explore the level of evidence used to support the withdrawal of marketing authorisation of drug products in the time period 2002 2011 in the EU as a whole.
In the framework of the authorisation of medicinal products regulated by the Regulation (EC) No 726/2004 and Directive 2001/83/EC as amended and the CTD, and additional implementing Directives and guidelines, the new Regulation (EC) No 1901/2006 is an important new piece of legislation focusing on the requirements to improve the situation for the paediatric population.
For homeopathic medicinal products with therapeutic indications or in a form to be administered other than orally or externally, the usual rules governing the market authorisation of medicinal products were to be applied.
Although not significant, it shows that the odds of authorisation for products based on existing synthetic entities may be about four times higher compared to biotechnological products.
In addition, the initial comparative assessments of substances available for a certain common use may be more demanding than a repeated assessment that is triggered by an application for authorisation of another product for the same use.
Rulebook on the contents of the application, the documentation and detailed requirements in respect of the premises, equipment and staff for granting authorisation for production of medicinal products (Official gazette No. 106/07,88/2010, 36/11, 53/11, 136/11, 11/12, 147/13, 27/14, 43/14, 88/15).
The objective of this study was to determine the nature of evidence used to support the withdrawal of marketing authorisations of drug products for safety reasons throughout the European Union (EU) between 2002 and 2011.
