FarmavitaR+

Are Nanotubes related to Mesothelioma?

Nanotechnology is the emerging scientific field which includes the study of small, thin, carbon-based materials known as nanotubes (also called CNTs),  which are becoming widely used in a plethora of products ranging from technologically advanced items utilized by NASA to everyday items used in the home.  These nanotubes are increasingly popular due to their light weight and supreme strength, which is said to be stronger than steel.

As the variety of uses for nanotubes increases, researchers continue to do studies and tests related to the consequences of nanotube use. Current research suggests that exposure to long multi-walled carbon-based nanotubes may lead to the development of mesothelioma, a deadly form of cancer that affects the lining of the lungs and has no known cure. Scientists claim that there is no cause for immediate concern, but that further testing related to nanotube exposure and the onset of mesothelioma is crucial.

 Readability (QRD) Testing of Patinet Information Leaflet (PIL)

Since 2005, marketing authorization holders of medicines are required to have the patient information leafets for their products readability tested. The European Directive 2004/27/EC (a revision of Directive 2001/83/EC) defines it as follows: 'The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use' .

eCTD Viewer and Validator

GECCO is a new eCTD Viewer that provides a uniform and consistent view of eCTDs in the different regions. 

New Legislation for Pediatric Medicines

On 23 October 2006, the Council of the European Union approved all the compromise amendments to the proposal for a Regulation on Medicinal Products for Paediatric Use which were agreed at its second Parliamentary reading. The Regulation was officially published on 27 December 2006 and will enter into force on 26 January 2007.

Timeframe for DMF development

Timeframe to development and submission of DMF is 8 to 9 months. In some cases when you have an experienced project team and when you are in a hurry timeframe could be squeezed to 4 months.

New legal framework for harmonisation of the data exclusivity

The new periods of data exclusivity will only take effect for reference products applying for marketing authorisation after the new law is fully in effect (around November 2005). Therefore, the first generics applications under the 8+2+1-year data exclusivity period will not occur until late 2013.

Simplified MRP procedure for EU candidates 

For the Czech R., Slovak R., Hungary, Croatia, Romania and Bulgaria there is simplified MRP procedure, also known as CADREAC prcedure. Because of simplicity of CADREAC procedure we suggest you to use this procedure for this countries, in cases when you have MA in RMS. Details about procedure could be submitted by Farmavita.  

Please take a look at  the official nCADREAC web site http://www.newcadreac.org/cadreac.html