Blog
RSS FeedPosted by Michael Wonder on 04 Oct 2024
Medicines regulators weigh hope and hype with new Alzheimer’s drugs
30 September 2024 - Swiss medicines regulator Swissmedic is expected to decide by the end of the year whether to approve ...
Posted by Michael Wonder on 25 Jul 2024
Switzerland’s drug approval process lags behind Europe
24 July 2024 - According to a recent study, medicines are approved on average 249 days later in Switzerland than by ...
Posted by Michael Wonder on 02 Jul 2024
Standardisation of practice on publication of indications in Swiss Public Assessment Report
1 July 2024 - In order to standardise practice, Swissmedic will in future publish both the proposed and approved indications in ...
Posted by Michael Wonder on 03 Jun 2024
Project Orbis: quicker access to promising cancer treatments
29 May 2024 - Scientific analysis confirms successful Swissmedic participation in international initiative to expedite access to innovative cancer drugs. ...
Posted by Michael Wonder on 14 May 2024
Effect of Project Orbis participation by the Swiss regulator on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis
13 May 2024 - Expedited market access for novel and efficacious drugs is warranted for patients. Since 2020, Swissmedic (The Swiss ...
Posted 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) ...