Switzerland

Companies looking to conduct decentralized clinical trials in Europe can now easily see how Switzerland’s rules and processes compare with those of EU member states.

The Swiss firm’s plans to go public are a boost for the antibiotics space and for hopes that the continent’s biotechs may follow their US counterparts and find financial solutions on the capital markets.

Medtechs will be indirectly affected by a new law in Switzerland that unifies the amount of funding allocated to inpatient and ambulatory care.

Switzerland’s devices MRA with the EU is fully back on the agenda following a broader, historic EU-Swiss future trade deal agreed on 20 December. Additionally, Swiss Medtech is pursuing MDR improvements with EU counterparts, and the Swiss authorities will lay the ground in 2025 to permit US FDA-approved in Switzerland.

Generics Bulletin reviews the latest developments in the regulatory arena across the globe.

An agreement between the EU and Switzerland potentially opening the way for renewal of the MRA – enabling barrier-free cross-border medtech trade – could be concluded as early as December. More good news for Switzerland, relating to the acceptance of FDA-approved products into the country, could follow in Q1 2025.

Swissmedic has removed the requirement for companies to participate in accelerated application hearings in certain situations.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.