Regulación de ciencias de la vida

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Artículos Recientes

  •  
    31/01/2025
    United Kingdom

    CMS Life Sciences Vital Signs Winter 2024/2025

    In our winter edition of Vital Signs we review how the new Labour Government in the UK aims to bring about significant changes to the life sciences & healthcare sector. We consider some key aspects of the party’s pre-election life sciences strategy and some sector-targeted actions taken by Labour since winning power. The Labour Government has also delivered on its promise to introduce an Employment Rights Bill within its first 100 days of office which it has described as the “biggest upgrade to rights at work for a generation”. That, along with a new duty to prevent sexual...
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  •  
    27/01/2025
    United Kingdom

    Clinical Trials: UK regulatory landscape set for change

    IntroductionOn 12 December 2024, a significant milestone was reached in the evolution of the UK's clinical trial landscape as the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 were laid before Parliament for debate (the “Updated Regulations”). The Updated Regulations are set to amend the UK’s existing regulatory framework, marking a pivotal shift in how clinical trials are conducted in the UK.With a 12-month implementation period, the Updated Regulations are expected to come into force in January 2026. We set out below some of the key changes contemplated...
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  •  
    24/01/2025
    Ukraine

    Ukraine introduces updated labelling regulations for medicines

    On 18 January 2025, new labelling requirements for medicinal products in Ukraine went into force. These amendments restrict promotional information on labelling, prohibit references to entities other than the manufacturer or marketing authorisation holder (MAH) on packaging, and grant new powers to the Ministry of Health and the Quality Inspectorate to suspend marketing authorisations and circulation of non-compliant medicines. Pharmaceutical companies must address these regulatory changes and ensure compliance.In a previous Law-Now article, we provided analysis of the official interpretations...
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  •  
    16/01/2025
    International

    CMS Expert Guide on Beauty

    With a highly circumspect online and IRL consumer, the beauty industry is facing increasing scrutiny on everything from ingredients to their supply chain. For those offering treatment services in particular, which has until now been the wild west of wellness, there’s a shift in consumer demand for transparency and accountability – namely a desire for better regulation and insurance. This follows well documented horror stories in national press worldwide of those travelling to secure these services at bargain prices with catastrophic results.This Expert Guide on Beauty considers...
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  •  
    15/01/2025
    China

    2025 – Topics that may Concern You

    Companies doing business in China constantly have to deal with changes in regulations and new laws. This will also continue in 2025.Topics such as the new PRC Company Law, new PRC Tariff Law, PRC Regulations on Export Control of Dual-Use Items, network data security management, data transfer, opening up capital markets to foreign investment, and raise of statutory retirement age of employees etc. will continue to be a concern for many companies in China in 2025.Complying with regulatory requirements is one of the key challenges for foreign companies and investors in China, not only in terms of...
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  •  
    27/12/2024
    China

    China Launched Pilot Program on Segmented Production of Biological Products

    On 21st October 2024, the National Medical Products Administration (“NMPA”) issued the Pilot Program for Segmented Production of Biological Products (“Pilot Program”) with immediate effect.Segmented production of biological products is a manufacturing approach where the production process of biological drugs is divided into several stages, with each stage potentially being outsourced to different contract manufacturing organizations (“CMOs”). This approach involves breaking down the entire production cycle into specialized segments, such as upstream processing...
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