Blog
RSS FeedPosted by Michael Wonder on 07 Nov 2023
Germany, Belgium and France among those hit hardest as Commission’s Pharma-legislation proposals risk Europe losing a third of its share of global R&D by 2040
6 November 2023 - The European Federation of Pharmaceutical Industries and Associations (EFPIA) is publishing new research which assesses the ...
Posted by Michael Wonder on 04 Apr 2023
New features further strengthen Priority Medicines scheme (PRIME)
4 April 2023 - The EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to ...
Posted by Michael Wonder on 05 Mar 2023
Replacing RCTs with real world data for regulatory decision-making: a self-fulfilling prophecy?
2 March 2023 - Real world data are advocated as an alternative approach to randomised clinical trials for closing knowledge gaps ...
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 ...
Posted by Michael Wonder on 24 May 2022
EMA guidance supports development of new antibiotics
24 May 2022 - As part of its efforts to support a global approach to the development of new antimicrobial medicines, ...
Posted by Michael Wonder on 02 Feb 2022
New order: European cancer coalition calls for cancer treatment overhaul
2 February 2022 - Coalition urges reformation of EU wide drug research and development to drive treatment optimisation ...
Posted by Michael Wonder on 21 Jan 2022
International regulators’ recommendations on COVID-19 vaccines and the Omicron variant
21 January 2022 - International regulators have published a report today highlighting their discussions on the effectiveness of current vaccines against ...
Posted by Michael Wonder on 10 Dec 2021
International regulators stress continued need for COVID-19 therapeutics
11 December 2021 - EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities that urges all ...
Posted by Michael Wonder on 28 Oct 2021
Repurposing of authorised medicines: pilot to support not for profit organisations and academia
28 October 2021 - EMA and the Heads of Medicines Agencies are launching a pilot project to support the repurposing ...
Posted by Michael Wonder on 16 Jul 2021
International regulators work towards alignment on development and authorisation of second generation COVID-19 vaccines
16 July 2021 - Regulatory convergence is critical for expediting and streamlining global development and authorisation of new or modified COVID-19 ...
Posted by Michael Wonder on 29 Jun 2021
Update of EU recommendations for 2021–2022 seasonal flu vaccine composition
28 June 2021 - EMA has issued an update of the EU recommendations for the influenza virus strains that vaccine ...
Posted by Michael Wonder on 28 Jun 2021
Success rate for marketing authorisation applications from SMEs doubles between 2016 and 2020
28 June 2021 - EMA has published today a report highlighting the Agency’s support for micro, small and medium sized ...
Posted by Michael Wonder on 25 Feb 2021
Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
25 February 2021 - EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in ...
Posted by Michael Wonder on 03 Feb 2021
New toolbox available for EMA's PRIME designees
2 February 2021 - The European Medicines Agency has released a draft guidance to assist drug developers using its Priority ...
Posted by Michael Wonder on 23 Nov 2020
Workshop on regulatory support for development of orphan medicines
23 November 2020 - On Monday, 30 November, EMA is hosting a workshop to discuss the benefits and impact of ...