Blog
RSS FeedPosted by Michael Wonder on 07 May 2021
International regulators and WHO call for wider public access to clinical data
7 May 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation are urging pharmaceutical companies to ...
Posted by Michael Wonder on 04 Feb 2021
EMA COVID-19 assessments ‘OPEN’ to non-EU regulators
4 February 2021 - EMA is piloting a new ‘OPEN’ initiative to increase international collaboration on the evaluation of COVID-19 vaccines ...
Posted by Michael Wonder on 31 Oct 2020
Extra transparency measures for COVID-19 vaccines and therapeutics
30 October 2020 - Today the EMA has implemented two further extra transparency measures for COVID-19 medicines, by publishing both ...
Posted by Michael Wonder on 05 Oct 2020
EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines
5 October 2020 - The EMA has re-affirmed today that it will uphold its long-standing commitment to independence and transparency ...
Posted by Michael Wonder on 03 Jun 2020
EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication
1 June 2020 - In a response to officials at Germany’s IQWiG and the Cochrane Collaboration, EMA Executive Director Guido ...
Posted by Michael Wonder on 29 Jan 2020
Documents disclosed to the EMA as part of an MA application process are not presumed to be confidential
28 January 2020 - On 22 January 2020 the CJEU handed down two decisions in which it decided that the ...
Posted by Michael Wonder on 22 Jan 2020
Court of Justice upholds EMA’s approach to transparency
22 January 2020 - EMA welcomes today’s two appellate judgments by the Court of Justice that confirmed, in clear and ...
Posted by Michael Wonder on 15 Aug 2018
EMA scales back transparency initiatives because of workload
14 August 2018 - The European Medicines Agency has scaled back its landmark clinical trial data policies, the drug regulator ...
Posted by Michael Wonder on 10 Aug 2018
The need for transparency of clinical evidence for medical devices in Europe
11 August 2018 - To use medical devices rationally, health-care professionals must base their choices of which devices to recommend for ...
Posted by Michael Wonder on 06 Feb 2018
General Court confirms EMA approach to transparency
6 February 2018 - Three rulings clarify the scope of commercial confidentiality with regard to authorised medicines ...
Posted by Michael Wonder on 20 Oct 2017
Unparalleled access to clinical data - one year on
20 October 2017 - Over 3,000 clinical documents published, 3,600 registered users and positive stakeholder feedback. ...
Posted by Michael Wonder on 29 Jul 2017
Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study
26 July 2017 - Goldacre et al. set out to identify the policies of major pharmaceutical companies on transparency of trials, ...
Posted by Michael Wonder on 23 Mar 2017
Call for experts in anonymisation of clinical data
23 March 2017 - EMA to set up technical group in the context of the publication of clinical data ...
Posted by Michael Wonder on 14 Mar 2017
Release of documents on two medicines temporarily halted
14 March 2017 - EMA’s appeals against interim measures are dismissed by Court of Justice ...
Posted by Michael Wonder on 20 Feb 2017
The European Medicines Agency and publication of clinical study reports: a challenge for the US FDA
20 February 2017 - The US FDA has been the standard of drug regulation worldwide for decades. ...