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May 02, 2016
In a move to encourage drug development, EU regulators are offering scientific advice to companies on major efficacy, safety, and quality issues at an early stage.
April 02, 2016
The European Commission publishes regulations on mandatory packaging safety features to fight counterfeiting.
March 02, 2016
The EU is striving to reduce the costs and administrative burden facing pharmaceutical manufacturers when complying with variations regulations for keeping authorization dossiers up to date.
February 01, 2016
The EU’s key objectives include improving medicines access, tackling drug shortages, and increasing administrative efficiency in its regulatory framework.
January 01, 2016
Leading nations are backing moves to strengthen WHO’s central role in international health security following the Ebola crisis, which sparked criticisms on the organization’s ability to address a pandemic outbreak.
December 02, 2015
Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
November 02, 2015
The scheme aims to ensure that EMA and licensing authorities of EU member states will use the same IT system, based on a single data standard.
October 02, 2015
The complexity of new packaging regulations laid out in the Falsified Medicines Directive could threaten the existence of smaller pharma and packaging companies.
September 02, 2015
EU and US regulators are striving to work together on improving GMP inspection efficiencies and avoiding duplication of efforts.
August 02, 2015
The trend towards personalized medicines in Europe requires a more integrated framework that regulates the approval of devices and diagnostics.