European Commission

EMA PSUR database fit for purpose

EMA PSUR database fit for purpose

By Gareth Macdonald

Drugmakers will be able to upload drug safety data to a single website from next year after a database developed by the EMA has been deemed fit for purpose by independent auditors.

European Parliament in Strasbourg, France

EMA tells us it looks forward to continuing close relationship with DG SANCO

Juncked: Plan to move EMA from DG Health to DG Enterprise is abandoned

By Gareth Macdonald

DG Health will keep responsibility for the EMA according to European Commission President-elect Jean-Claude Juncker, who confirmed plans to hand the agency to DG Enterprise have been abandoned.

EFCG warns API stockpiling may be buffering impact of import laws

EU API shortages avoided so far… thanks to stockpiling

By Georgina Haacke

Concerns recently introduced import laws would cause EU-wide API shortages now appear unfounded, but European industry groups say the buffering effects of stockpiling mean it is still too early to be sure supplies will not be affected.          

EC Updates Guidance to Ensure Supplier Compliance

EC Updates Guidance to Ensure Supplier Compliance

By Zachary Brennan

The European Commission has updated its GMP guidance to notify manufacturing authorization holders (MAHs) of their legal obligation to ensure that active substances are produced in accordance with GMP.

UPS’ TNT takeover bid fizzles out

UPS’ TNT takeover bid fizzles out

By Gareth Macdonald

United Parcel Service (UPS) has abandoned its bid to buy Holland-based logistics firm TNT Express after the European Commission said it would block the deal.

EU, clinical trial, CRO, directive, simplify

Poll closes 31/07/12

CRO Poll: What do you think of proposed changes to EU trial laws?

By Gareth Macdonald

The EC says proposals to replace the Clinical Trials Directive with simplified rules will make Europe more attractive for trials, but what do CROs think? Share your opinions in this exclusive poll.


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