Lebenswissenschaften - Regelung

Aktuelle eAlerts

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  22.03.2023

  Europe

  Is a pa­ti­ent in a cli­ni­cal tri­al con­side­red to be a mem­ber of the pu­blic in the con­text of no­vel­ty pri­or art?

  In T 0670/20, the question was whether the internal structure of medicinal tablets had been made available to the public by patients taking part in clinical trials involving administration of the tablets. The Appeal Board found that the patients participating in the trial had entered into a special relationship with the investigators of the trials and were not free to dispose of the tablets. Accordingly, the patients were not members of the public for novelty purposes.However, the Board acknowledged that the patients were not under a duty of confidence with respect to their participation to the...

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  10.03.2023

  United Kingdom

  New pro­po­sals pu­blis­hed for post-Brex­it re­form of UK Health­Tech re­gu­la­ti­on

  IntroductionOn 7th March 2023, the UK Life Sciences Council Advisory Group (the “Advisory Group”) published new proposals to accelerate the delivery of a new UK HealthTech regulatory system, which were agreed across three priority areas:International recognitionRoutes for innovationSystem capacityBackgroundThe Advisory Group was formed in December 2022 by three senior members of the Life Sciences Council, Will Quince MP, Minister of State at the Department of Health and Social Care, Dr June Raine, CEO, Medicines and Healthcare products Regulatory Agency (“MHRA”) and Peter...

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  09.03.2023

  United Kingdom

  Go­vern­ment out­li­nes its stra­te­gy to im­pro­ve ac­cess to pa­ti­ent health­ca­re through Med­Tech

  The Department of Health and Social Care (“DHSC”) published its medical technology strategy in February 2023. This is the first strategy published which recognises the importance of leveraging the medical technology (“MedTech”) industry in improving access and delivering first class healthcare to patients in the current climate where the NHS is facing multiple pressures. Although this is a high level strategy, it does outline some important areas of focus for the DHSC which will have implications on the MedTech industry.The DHSC estimates the NHS spends £10 billion...

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  06.03.2023

  China

  Pro­vi­si­ons on the Su­per­vi­si­on and Ad­mi­nis­tra­ti­on of Drug Mar­ket Aut­ho­riza­t­i­on Hol­der Im­ple­men­ta­ti­on of the Main Re­s­pon­si­bi­li­ty of Drug Qua­li­ty and Safe­ty

  The National Medical Products Administration (“NMPA”) promulgated the Provisions on the Supervision and Administration of Drug Market Authorization Holder Implementation of the Main Responsibility of Drug Quality and Safety (“Provisions”) on 29 December 2022. The Provisions will take effect as of 1 March 2023.The Provisions are issued to further implement the Drug Administration Law of the People's Republic of China ("Drug Administration Law", latest revised and effective as of 1 December 2019), the Administrative Measures for Drug Registration (effective as of 1 July 2020),...

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  06.03.2023

  Schweiz

  Schweiz: Neu­es Zu­las­sungs­recht für am­bu­lan­te Leis­tungs­er­brin­ger - Wer­den EU-Ärz­tin­nen und -Ärz­te rechts­wid­rig be­nach­tei­ligt?

  GB

  Seit dem 1. Januar 2022 gelten in der Schweiz neue Bestimmungen für die Abrechnung von ambulant erbrachten Leistungen zulasten der obligatorischen Krankenpflegeversicherung (OKP). Davon betroffen sind alle ambulant tätigen Leistungserbringer, einschliesslich Ärztinnen und Ärzte.Das neue Zulassungsrecht bezweckt, die Anforderungen an die zulasten der OKP tätigen Leistungserbringer zu erhöhen und dadurch die Qualität und die Wirtschaftlichkeit der von ihnen erbrachten Leistungen zu verbessern. Der Zweck des neuen Zulassungsrechts unterscheidet sich von den ebenfalls...

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  02.03.2023

  China

  Ad­mi­nis­tra­ti­ve Re­gu­la­ti­ons on En­t­er­pri­se Im­ple­men­ta­ti­on of the Main Re­s­pon­si­bi­li­ty for the Qua­li­ty and Safe­ty of Me­di­cal De­vices

  The National Medical Products Administration (“NMPA”) promulgated the Provisions on the Supervision and Administration of Enterprise Implementation of the Main Responsibility of Medical Device Quality and Safety (“Provisions”) on 29 December 2022. The Provisions will take effect as of 1 March 2023.The Provisions are issued to further implement the Regulations on the Supervision and Administration of Medical Devices, the Regulations on the Supervision and Administration of Medical Device Manufacturing, the Regulations on the Supervision and Administration of Medical Device...

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