Blog
RSS FeedPosted by Michael Wonder on 01 Nov 2023
Landmark listing of first three countries as WHO listed regulatory authorities
31 October 2023 - The Health Sciences Authority, Singapore; the Ministry of Food and Drug Safety, Republic of Korea; and ...
Posted by Michael Wonder on 22 Sep 2023
Regulatory challenges: is a surrogate endpoint instead of overall survival enough for regulatory approval of (neo)adjuvant cancer treatment? The Swissmedic perspective.
21 September 2023 - From a regulator's point of view, a market authorisation can only be granted with a positive benefit-risk ...
Posted by Michael Wonder on 22 Aug 2023
Swiss drug review times trail FDA and EMA, increased due to COVID
21 August 2023 - While lagging other regulators in bringing new drugs to market, Swiss regulators say their review times ...
Posted by Michael Wonder on 25 Jan 2023
Pricing of medicines in Switzerland | Three yearly price review: What are the most important changes for 2023?
24 January 2023 - The Federal Office of Public Health reviews the price of every medicinal product that is reimbursed under ...
Posted by Michael Wonder on 30 Nov 2022
Swiss National Council votes to accept FDA approved medical devices
29 November 2022 - On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to ...
Posted by Michael Wonder on 08 Jun 2022
BioCryst announces approval of Orladeyo (berotralstat) by Swissmedic
7 June 2022 - -- BioCryst Pharmaceuticals today announced that Swissmedic has granted marketing authorisation for oral, once-daily Orladeyo (berotralstat) ...
Posted by Michael Wonder on 14 May 2022
Hansa Biopharma announces temporary marketing authorisation in Switzerland for Idefirix (imlifidase) in kidney transplantation
13 May 2022 - Idefirix is now granted marketing authorisation within the EU, the U.K., Israel and Switzerland. ...
Posted by Michael Wonder on 07 Nov 2021
AstraZeneca pulls request for Swiss approval of COVID shot
5 November 2021 - AstraZeneca says it is withdrawing its application for approval of its COVID-19 vaccine in Switzerland because the ...
Posted by Michael Wonder on 03 Dec 2020
Incomplete data stalls Swiss authorisation of COVID-19 vaccines
3 December 2020 - Switzerland’s medical regulator Swissmedic says it lacks the necessary information to sign off on three different coronavirus ...
Posted by Michael Wonder on 22 Aug 2020
Swissmedic approval times slow down
20 August 2020 - Swissmedic took 4% longer to process each new application for a new active substance (NA NAS) ...
Posted by Michael Wonder on 04 Apr 2020
Swiss Government expands powers to force firms to make supplies to fight COVID-19
3 April 2020 - The Swiss government on Friday boosted its powers to order companies to raise production of critical ...
Posted by Michael Wonder on 13 Nov 2019
FDA’s Project Orbis may expand to Singapore and Switzerland
12 November 2019 - The US FDA may expand a pilot project that allows for simultaneous drug approval decisions from ...
Posted by Michael Wonder on 17 Sep 2018
Dutch, Swiss regulators forge agreement on data exchange
14 September 2018 - The heads of the Netherland’s Medicines Evaluation Board and Swissmedic have signed a memorandum of understanding ...
Posted by Michael Wonder on 01 May 2018
A comparative review of marketing authorisation decisions in Switzerland, the EU, and the USA
19 April 2018 - In this study we compared Swissmedic’s regulatory marketing authorisation decisions to those of the US FDA ...
Posted by Michael Wonder on 24 Feb 2018
FDA approves drugs before EMA and Swissmedic, comparison finds
23 February 2018 - From 2007 to 2016, the US FDA approved more new drugs and biologics first than its ...