Life Sciences - Regulation

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Recent Articles

  •  
    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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  •  
    23/01/2024
    Ukraine

    Ukrainian healthcare authority takes further steps to introduce eCTD standard

    Through Order No. 1789 of 13 October 2023 (as further amended by the Order of the Ministry of Health of Ukraine No. 1924 of 8 November 2023), the Ministry of Health of Ukraine (MoH) inter alia introduced the option of submitting registration dossiers for medicinal products in electronic Common Technical Document (eCTD) format. MoH made corresponding amendments to the Procedure for Conducting Expert Evaluation of Registration Materials for Medicinal Products, approved by MoH’s Order No. 426 dated 26 August 2005 (Procedure).Additionally, the Order No. 1789 introduces changes to the Procedure...
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  •  
    09/01/2024
    England and Wales

    Ofsted under scrutiny – School inspections to resume on 22 January 2024 having been paused for inspectors to receive mental health awareness training

    The inquest into the devastating suicide of headteacher Ruth Perry sparked a national conversation about the impact of Ofsted inspections on school leaders and their well-being and whether the current inspection regime is fit for purpose. The inquest ruled that the Ofsted inspection “contributed” to Mrs Perry’s death and it was noted that the inspection “lacked fairness, respect and sensitivity”. Furthermore, it was considered that the inspection at times was “rude and intimidating”. The coroner's conclusion, linking Mrs Perry's mental health deterioration...
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  •  
    08/01/2024
    EU

    Adapting to the new EU Data Act: implications for medical devices and other health devices

    In recent years, the European Commission developed a European data strategy, which aims to create a single European market in which data can circulate freely. As the European Commission has emphasized repeatedly, the creation of such a single market is essential in the healthcare sector because data enables faster development of medicinal products and medical devices, assists healthcare professionals in making diagnoses and supports the decision-making of clinicians. Therefore, the European Commission recently took several legislative initiatives, some of which apply to all sectors (e.g. the Data...
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