The European Commission has adopted a Communication outlining a set of actions addressing the “Strategic Approach to Pharmaceuticals in the Environment”. The plan that the Commission presented on March 11th, identifies six action areas concerning all stages of the pharmaceutical life cycle, where improvements can be made.
EMA Booklet – From lab to patient
EMA has published a booklet describing the journey of a medicine for human use authorised through EMA, from initial research to discussions on patient access to medicines across the EU: From laboratory to patient: the journey of a centrally authorised medicine – Link.
SPC manufacturing waiver
On January 23rd, 2019, the European Parliament’s JURI Committee voted its amendments to the Commission’s proposal amending Regulation (EC 469/2009) concerning the supplementary protection certificate for medicinal products. For more information, download our briefing note. Download.