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December 02, 2022
The European Human Medicines Directive and Regulation is due to be updated by the end of 2022, but what changes are on the cards?
November 02, 2022
The DGA seeks to increase trust in data sharing, strengthen mechanisms to make data more available, and overcome obstacles to the reuse of data, which are vital ingredients to the intersectoral use of health data.
October 02, 2022
Under the revised NIS-2 Directive in Europe, pharma companies will need to be proactive in safeguarding their digital assets.
September 02, 2022
A new unitary patent system is due to come into effect in Europe later on this year.
August 02, 2022
Pharma’s leveraging real-world evidence to drive product approval, reimbursement, and market access.
July 02, 2022
A new strategy aims to bring in legislative reforms that will impact medicinal product regulation within Europe.
June 02, 2022
EMA has been assigned a formal role in preparing for and managing future public health crises within the EU through the formalization of ad-hoc structures and processes that were employed during the COVID-19 pandemic.
May 02, 2022
On 26 May 2022, the European Commission will roll-out the new in-vitro diagnostic regulation.
April 13, 2022
Swissmedic grants conditional marketing authorization for Novavax COVID-19 vaccine for individuals aged 18 years or older in Switzerland.
April 02, 2022
In January 2022, Europe started to implement EU-CTR, a new regulatory framework for clinical trials, but what does this mean for pharma clinical research?