Slovakia

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J&J says it has “exhausted all current viable avenues” to get its antidepressant nasal spray Spravato reimbursed on England’s National Health Service, after NICE decided against re-appraising the drug following numerous funding rejections.

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 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.

The latest notified body listing brings total number of EU designated Medical Device Regulation testing and certification organizations to 35.

Slovakia has introduced a new system for agreeing managed entry agreements that will make it easier for companies to get their innovative medicines to the market.

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.

The latest designation of a notified body in the context of the MDR means that the EU only needs one more to make the landmark total of 30. It seems that this may be realized soon.

April saw many more regulatory developments and documents compared to March, and also the promise of much to come over the near-term. With HTA and AI rules asking much more from the sector, these are demanding times for medtech.

A new EU notified body has been designated under the IVD Regulation after nine months of an absence of news; but another hiatus is likely now until October.