Blog
RSS FeedPosted by Michael Wonder on 01 Feb 2025
Refined interpretation of the Mutual Recognition Agreement between Canada and Switzerland
31 January 2025 - Swissmedic and Health Canada agreed to expand their approach regarding the implementation of the current mutual ...
Posted by Michael Wonder on 19 Jan 2025
New EU rules for health technology assessments become effective
10 January 2025 - Enhanced EU collaboration to allow faster and wider access to innovative health technologies. ...
Posted by Michael Wonder on 30 May 2024
European Commission adopts rules for joint clinical assessments
29 May 2024 - The European Commission has adopted joint clinical assessment rules detailing how national health care systems should ...
Posted by Michael Wonder on 23 May 2024
COTA announces extended collaboration with FDA to advance the use of real world data in cancer research
22 May 2024 - Today, COTA announced an extension of its research collaboration with the US FDA Oncology Center of Excellence. ...
Posted by Michael Wonder on 20 May 2024
Global cooperation and early access—clinical outcomes matter
13 May 2024 - In modern cancer drug development, surrogate measures are commonly used as clinical trial endpoints instead of more ...
Posted by Michael Wonder on 07 Feb 2024
FDA and EMA launch parallel scientific advice pilot program for complex generics
7 February 2024 - CDER’s Office of Generic Drugs and the EMA launched a voluntary pilot program to facilitate concurrent discussions ...
Posted by Michael Wonder on 02 Nov 2023
FDA notes “continued growth” of Orbis collaborative review program, adds EMA as observer
1 November 2023 - There has been “continued growth” in the number of applications submitted to Project Orbis, and the ...
Posted by Michael Wonder on 28 Jul 2023
CDER collaborates with global regulators on pharmaceutical quality assessments and inspections
28 July 2023 - The FDA and the EMA recently completed the first collaborative assessment of a proposed post-approval change ...
Posted by Michael Wonder on 23 Feb 2023
FDA continues important work to advance medical products for patients with rare diseases
23 February 2023 - Patients with rare diseases are experts in their health condition. They provide a unique perspective, and ...
Posted by Michael Wonder on 11 Oct 2022
EMA publishes minutes of bilateral EMA – EUnetHTA meeting (June 2022)
11 October 2022 - The chairs welcome participants to the first bilateral under the new Work Plan between EUnetHTA 21 ...
Posted by Michael Wonder on 06 Sep 2022
NASWSI and Project Orbis - are they essentially the same?
7 September 2022 - We compare and contrast the two initiatives to bring new medicines to the market faster. ...
Posted by Michael Wonder on 05 Sep 2022
International work-sharing - first medicines approved by all five Access Consortium regulators
2 September 2022 - The TGA has approved two new medicines as part of the Access New Active-Substance Work-Sharing Initiative. ...
Posted by Michael Wonder on 22 Jul 2022
Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making
20 July 2022 - EMA has endorsed a joint statement calling for international collaboration to enable the generation and use ...
Posted by Michael Wonder on 26 Jun 2022
US seeks pharmaceutical deal with Switzerland to fast-track FDA approvals
27 June 2022 - The Biden administration wants to reach a narrow sectoral trade agreement with the Swiss pharmaceutical industry, ...
Posted by Michael Wonder on 20 Jun 2022
Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic
20 June 2022 - Lessons learned from international collaboration on observational research during the pandemic were highlighted during the latest global ...