Quote:
Originally Posted by Pierre
All the standards bodies work together and unify standards where possible and where there is benefit.
I sit on a British Standards committee.
You have British Standards I.e. BS XXXX
Then if the standard is ratified by the European standards agency such as CEN or CENELEC it gets the EN prefix. I.e. BS EN XXXX
Then if it is adopted as an international standard it becomes an ISO XXXX
Then you have other standards bodies such as ITU and Cigre.
They all talk to each other.
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Yep, that's my experience too with the Pharmaceutical Industry. The UK regulatory agency being the MHRA which is also a member of the European Medicines Agency. Alignment of the demands of the all the regulatory agencies in Europe mean that you pass muster with the MHRA, you are then free to sell pharmaceuticals across Europe.
The next sticking point is what if you want to sell outside of Europe? Well that's where the International Conference on Harmonisation comes in - a collaboration between the EMA (Europe), FDA (US), MHLW (Japan), HPFB (Canada) and Swissmedic (Switzerland) This group are working towards a consistent way of regulating Pharmaceuticals globally as there are many differences currently and this is a huge cost for drug manufacturers.
See also aviation (EASA)