Slovakia

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.

The practice of telehealth got the impetus it had long needed during the pandemic, as experiences in Czechia and neighboring economies in eastern Europe show in a regional roundup by Kinstellar.

While the EU attempts to accelerate the pace of its unified approach to vaccine roll-out, some eastern European countries are taking their own decisions.

The latest update in the Medical Device Regulation page of the European Commission's Nando database represents the 18th listing under the new regulation. Numbers are rising slowly.

Despite COVID-19 distancing measures and fears that new notified body appointments would grind to a halt, there is now a new notified body for the EU Medical Device Regulation.

Cannibidiol (CBD) remains a scheduled drug in Slovakia after the country's parliament rejected a recent proposal to decriminalize the substance. 

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.

As a recent meeting of the United Nation's Commission on Narcotic Drugs, the World Health Organization recommended that CBD products with no more than 0.2% THC should not be considered controlled substances. In response, Slovakia down-scheduled CBD. The move and the discussion sparked by WHO's recommendation within the UN 's drug commission shines a new light on debates raging in the UK, where industry is currently facing claims that CBD products with any levels of THC whatsoever should be considered a controlled substance.

Speakers from several EU countries at last week's Medicines for Europe conference discussed the reasons behind the often wide inter-country disparities in biosimilar usage and the policies they are pursuing to try to remedy the situation.

Speakers from several EU countries at last week's Medicines for Europe conference discussed the reasons behind the often wide inter-country disparities in biosimilar usage and the policies they are pursuing to try to remedy the situation.

Neuraxpharm has acquired CNS specialty pharmaceutical company Farmax from SVUS Pharma, in a move that strengthens the firm’s European CNS leadership position by entering the Czech Republic, Slovakia and Hungary.

London has lost the European Medicines Agency to Amsterdam after the Dutch capital beat Milan in a voting process that ended in the drawing of lots. The EMA welcomed the choice of city, saying the decision met many of its requirements and would help to keep down staff losses and ensure business continuity, but Italy was hugely disappointed at losing out in what amounted to a toss of a coin.