European Regulatory Watch

Brexit: What Happens Next for Pharma?

February 02, 2020

The UK and Europe are entering a transitional period, which will involve negotiations across the board, including those on the pharma regulatory landscape.

European Regulators Strive to Make Up for Lost Ground

January 02, 2020

In 2020, European regulators are expected to start to be even more active in encouraging drugs innovations rather than hindering them through legal restrictions.

The Challenges for Regulators in the Digital Age

December 02, 2019

Regulators are facing huge challenges on how to deal with the digitalization transformation occurring in the healthcare and pharmaceutical sectors.

Investigating NDMA Impurities at EMA’s Request

November 02, 2019

Companies are facing a huge undertaking to be able to complete risk evaluations of all medicines containing chemically synthesized APIs by March 2020.

Out with the Old and In with the New European Commission

October 02, 2019

A new European Commission is likely, with the support of a new European Parliament, to give a higher profile to healthcare and pharmaceutical matters during its five years in office.

EMA’s Regulatory Impact: Not Yet in its PRIME

September 02, 2019

EMA is seeking ways to improve the effectiveness of its PRIME scheme, so that scientific innovations and new technologies more readily lead to novel medicines.

One Small Step for Man, One Giant Leap for Pharma Regulators

August 02, 2019

Pharmaceutical Technology Europe

European Union regulators have taken a significant step towards resolving some of the major supply-chain difficulties behind medicine shortages.