Blog
RSS FeedPosted by Michael Wonder on 15 Mar 2023
EMA-FDA parallel scientific advice program has ‘limited’ uptake
14 March 2023 - A review of the last five years of the parallel scientific advice program between the FDA ...
Posted by Michael Wonder on 08 Mar 2023
In Amsterdam, EU drugs regulator doesn’t want brothel moving in next door
7 March 2023 - Sex and drugs don’t mix, argues the EMA. ...
Posted by Michael Wonder on 16 Feb 2023
Human medicines: highlights of 2022
16 February 2023 - In 2022, EMA recommended 89 medicines for marketing authorisation. Of these, 411 had a new active substance ...
Posted by Michael Wonder on 06 Feb 2023
Actions to support the development of medicines for children
6 February 2023 - Regulators in the European Union have taken several initiatives in the past four years to increase the ...
Posted by Michael Wonder on 01 Feb 2023
Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU
31 January 2023 - From 31 January 2023, all initial clinical trial applications in the European Union must be submitted via ...
Posted by Michael Wonder on 19 Dec 2022
Facilitating decentralised clinical trials in the EU
19 December 2022 - The European Commission, the Heads of Medicines Agencies and the EMA have published recommendations that aim to ...
Posted by Michael Wonder on 23 Nov 2022
DARWIN EU welcomes first data partners
23 November 2022 - EMA has selected the first set of data partners to collaborate with DARWIN EU, the Data Analysis ...
Posted by Michael Wonder on 11 Nov 2022
CHMP issues opinion related to review of medicines within the Janus kinase inhibitor class
11 November 2022 - AbbVie announced today the EMA's CHMP has adopted an opinion following a nine month review of the ...
Posted by Michael Wonder on 28 Oct 2022
EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
28 October 2022 - EMA’s safety committee (PRAC) has recommended measures to minimise the risk of serious side effects associated ...
Posted by Michael Wonder on 10 Oct 2022
High quality data to empower data-driven medicines regulation in the European Union
10 October 2022 - EMA and the Heads of Medicines Agencies in the EU Member States are moving ahead with ...
Posted by Michael Wonder on 19 Sep 2022
Biosimilar medicines can be interchanged
19 September 2022 - EMA and the Heads of Medicines Agencies have issued a joint statement confirming that biosimilar medicines ...
Posted by Michael Wonder on 17 Sep 2022
EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines
16 September 2022 - The EMA’s CHMP has recommended converting the conditional marketing authorisations of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer’s ...
Posted by Michael Wonder on 17 Sep 2022
Take whatever COVID booster you can get, says head of EU drugs watchdog
14 September 2022 - People in Europe should take whatever COVID-19 booster is available to them in the coming months, ...
Posted by Michael Wonder on 30 Aug 2022
Accelerating clinical trials in the EU: publication of 2022-2026 workplan
30 August 2022 - The European Commission, the Heads of Medicines Agencies and the EMA have published the 2022-2026 workplan ...
Posted by Michael Wonder on 26 Aug 2022
Patient registries: EMA officials highlight opportunities in orphan drug development
25 August 2022 - Officials from the EMA tout the benefits of patient registries to support regulatory decision making for ...