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Swiss Medtechs Eye Near-Term Regulatory Progress On EU And FDA Fronts

Swiss Medtechs Eye Near-Term Regulatory Progress On EU And FDA Fronts

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.

Swiss Agency Optimizes Fast-Track Review, Temporary Authorization Routes

Swiss Agency Optimizes Fast-Track Review, Temporary Authorization Routes

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

Global Pharma Guidance Tracker – September 2024

Global Pharma Guidance Tracker – September 2024

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.

Global Medtech Guidance Tracker: September 2024

Global Medtech Guidance Tracker: September 2024

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.

Global Pharma Guidance Tracker – August 2024

Global Pharma Guidance Tracker – August 2024

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.

Global Medtech Guidance Tracker: August 2024

Global Medtech Guidance Tracker: August 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.

People On The Move At Galenica, Haleon, Alliance Pharma

People On The Move At Galenica, Haleon, Alliance Pharma

A round-up of the latest moves in Europe's consumer health industry: Galenica names head of new Products & Home Care business unit; Haleon appoints general counsel; Alliance Pharma eliminates COO role.

Regulatory Recap: Generic Medicines Work-Sharing Initiative Outlines Foreign Comparator Acceptability

Regulatory Recap: Generic Medicines Work-Sharing Initiative Outlines Foreign Comparator Acceptability

Generics Bulletin reviews the latest regulatory events across the world.

Global Pharma Guidance Tracker – July 2024

Global Pharma Guidance Tracker – July 2024

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.

Global Medtech Guidance Tracker: July 2024

Global Medtech Guidance Tracker: July 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 30 documents have been posted on the tracker since its last update.