Reform of pharma legislation: the debate on regulatory data protection
by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision…
The risk of a biosimilar void in Europe
by Giuliana Miglierini The undergoing revision of the pharmaceutical legislation aims, among others, to redefine data protection to…
The drug shortage situation – EIPG’s point of view
by Maurizio Battistini The shortage of medicines has been a major concern in the countries of the European…
EP’s draft position on Unitary SPC and SPC Regulation revision
by Giuliana Miglierini The Committee for Legal Affairs (JURI) of the European Parliament released the draft amendments to…
The UK’s statutory scheme revision for branded medicines
by Giuliana Miglierini The amendment of the statutory schemeregulating the increase in pricing and consequent clawback payments of…
Comments to the draft ICH guidelines Q2(R2) and ICH Q14
by Giuliana Miglierini The public consultation on the two draft guidelines ICH Q2(R2) on the validation of analytical…