Moscovici's proposals seek to resurrect a longstanding tax harmonisation policy, which has been blocked by hostile member states since 2011.
We think the EU has lost sight of its fundamental freedoms, with this never-ending harmonisation – for which Germans fear they will end up paying".
The International Conference on Harmonisation (ICH), which aims to provide a consistent set of standards for worldwide regulatory authorities and pharmaceutical industries, has not published guidelines specifically addressing biosimilars/biosimilar insulins.
Method validation followed the International Conference on Harmonisation (ICH) guidelines which evaluate linearity, detection limit, quantification limit, accuracy and precision.
"The one bit of a good news is that they result in harmonisation across Europe which is better than the existing situation with 27 different national laws, but the content of some these proposals is very onerous," said Marc Dautlich, head of information law at Pinsent Masons.
The project forms part of a wider programme, the African Medicines Regulatory Harmonisation (AMRH) Initiative which is coordinated by the African Union's New Partnership for Africa's Development (NEPAD).
In this project, we will systematically review the methodological literature on measurement error correction methods and the nutritional epidemiological literature on calibration studies of dietary assessment, a field of central importance in the study of G × E interactions and for which harmonisation is greatly needed.
They were devised by a UN committee based in Geneva called the World Forum for Harmonisation of Vehicle Regulations, which was dominated by people from the car industry.
This is not a harmonisation of tax rates, which will remain a national prerogative, but creates an alternative tax base to enhance the single market.
That, of course, is in anticipation of the EU Constitution, within which that harmonisation has a key role to play.
