Last year saw a high level of regulatory activity in the pharmaceutical industry and the omens for 2011 are, for a year at least, as, if not more, action-packed than the previous one.
Throughout 2010 the progress of the Falsified Medicines Directive was reviewed in this column and at the time of writing an agreement as to the final format of the Directive was awaited.
When the Directive is finally adopted, there will be considerable interest in the development by the European Commission of delegated acts, in which the technical detail of the application of the Directive is to be spelled out.
On the GMP front, there were a number of proposals for change to GMP Guidelines. Last year closed with draft revisions of Chapters 5 and 7 of the EU GMP Guide on Production and Outsourcing respectively, a Concept Paper on revisions to Chapter 6 (Quality Control) and another Concept Paper on Storage Conditions During Transport on the table for consultation.
It will be of interest to see what the 2011 work programme of the European Inspectors’ Working Group contains in terms of detail of further possible revisions in 2011.
On the UK investment front, December saw the welcome announcement by HM Government of its intention to introduce a ‘Patent Box’ scheme – a preferential tax regime of 10% for profits arising from patents that will encourage the commercialisation of discoveries in the UK.
The prognosis for 2011 is for another busy legislative year for the industry and this column will follow developments closely.