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Aktuelle eAlerts

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  16/04/2024

  APAC region

  Top developments and predictions in the Life Sciences & Healthcare sector in Asia-Pacific

  In this round-up, we look back at the top developments over the last 12 months in the life sciences & healthcare (LSHC) sector, and we look to the future with our top predictions for the coming year for businesses operating in the Asia-Pacific region.In 2023, China enhanced rules for the management of human genetic resources. It also intensified regulatory oversight in the sales of pharmaceuticals, medical devices, and cosmetics, particularly in the realm of online sales. Meanwhile, the Hong Kong government is actively working on unlocking the city’s potential in the Life Sciences &...

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  12/04/2024

  Europe

  Navigating clinical trial disclosures: No reasonable expectation of success in a patient sub-population in view of prior art reporting phase III clinical trial (T 1437/21)

  Recent EPO Board of Appeal decision T 1437/21 adds to a growing number of decisions concerning the patentability of second or further medical use inventions where the prior art relates to a clinical trial. At a time when the European Medicines Agency (EMA) is requiring increased transparency for EU clinical trials, this case law is of increasing importance to those operating in the pharmaceutical space.In brief, this decision further supports the position that the disclosure of a clinical trial protocol does not always mean there is a reasonable expectation of success of achieving treatment. The...

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  03/04/2024

  Ukraine

  Register of Damage for Ukraine is open for claims submission

  On 2 April 2024, the Register of Damage for Ukraine opened the claims submission process for compensation for damage, loss or injury caused by Russian aggression against Ukraine. The launch took place as part of the Ministerial Conference "Restoring Justice for Ukraine" co-hosted by the Netherlands, Ukraine and the European Commission at the World Forum in The Hague.As a reminder, the official website of the Register of Damage for Ukraine was launched on 4 March 2024. The website contains the following:documents governing the work of the Register;answers to frequently asked questions on the Register’s...

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  09/02/2024

  Ukraine

  Ukraine launches State Register of Sanctions

  On 29 January 2024, the President of Ukraine by the Decree No. 36/2024, approved the Decision of the National Security and Defence Council of Ukraine “On Approval of the Regulation on the State Register of Sanctions”. On 1 February 2024, the National Security and Defence Council of Ukraine launched the State Register of Sanctions on its website. The Register provides free public access to up-to-date and reliable information on persons and entities subject to Ukrainian sanctions.The Register is available in Ukrainian and English, and consolidates information regarding Ukrainian sanctions...

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  05/02/2024

  China

  2024 – Topics that may Concern You

  In China, companies constantly have to deal with changes in regulations and new laws. This will also continue in 2024.Topics such as update to the PRC Company Law, adapting Joint Ventures in accordance with the PRC Foreign Investment Law and the PRC Company Law, cross-border data transfer, employment management in the digital age, developments in China's competition law regime etc. will continue to be a concern for most companies in China in 2024. Complying with regulatory requirements is one of the key challenges for foreign companies and investors in China, not only in terms of general compliance,...

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  30/01/2024

  EU, UK

  What’s in a name? Updated EMA guideline on naming medicinal products processed through the centralised procedure comes into effect

  The updated EMA Guideline on the acceptability of names for human medicinal products processed through the centralised procedure was adopted by CHMP in December 2023 and came into effect on 1 January 2024.  The Guideline was updated following a public consultation which concluded in March 2022.Key pointsThe 7th revision of the Guideline builds on rather than overhauls the previous 2014 guidance, and provides more detail on specific scenarios that can arise during the assessment of names for new products by the Naming Review Group (“NRG”).  Key points to note include:Further...

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