OR WAIT null SECS
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.
August 02, 2019
European Union regulators have taken a significant step towards resolving some of the major supply-chain difficulties behind medicine shortages.
July 02, 2019
Will EMA’s draft guideline clarify questions about the assessment of drug device combinations in relation to the EU medical devices regulation?
May 01, 2019
Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.
April 01, 2019
The European Commission has published a strategy that will form the basis for the European Union’s policy on pharmaceuticals in the environment.
March 02, 2019
The European generics and biosimilars sector is working on the creation of a single pathway to accelerate development of and access to medicines.
February 02, 2019
Various groups and stakeholders from pharma, healthcare, and government are responding to a new draft environmental risk assessment guidance from EMA.
January 01, 2019
This coming year could see a combination of regulatory uncertainty and inactivity for the pharma industry, mainly as a result of Brexit.
December 02, 2018
EMA’s relocation to Amsterdam and resulting staff losses could severely weaken the agency’s role as a leading medicines regulator.
November 12, 2018
Pharma companies are concerned they may have to postpone plans for the commercialization of new combination products because of delays in obtaining marketing authorizations because of a lack of clarity about approval rules.