Making the Most of Regulatory Resources in the EUElectronic submissions, the new variations rules and how to make the most of the regulators' resources were high on the agenda at the European Generic medicines Association's latest meeting. Elisabet Montpart Costa and Maria Pilar Martin Barea report.

摘要

The European Generic medicines Association's 8th regulatory and scientific affairs conference took place on 29-30 January in Amsterdam. The event covered a number of issues affecting the generic medicines sector, such as making the most efficient use of existing resources by national competent authorities in order to achieve an efficient regulatory system in Europe, improvements to the variations regulations that will affect both authorities and industry, and the implementation of electronic submissions. It also discussed current experience and advice on how to update the patient information leaflet and the summary of product characteristics of generic medicines to reflect changes to the reference product, and touched on the European Commission's inquiry into competition in the EU pharmaceutical sector.