Regulación de ciencias de la vida

Artículos Recientes

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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

  Suiza

  Swi­t­ze­r­la­nd: New li­ce­n­si­ng law pa­s­sed for ou­t­pa­tie­nt se­r­vi­ce pro­vi­de­rs and pro­fe­s­sio­na­ls - Are EU do­c­to­rs bei­ng un­la­w­fu­l­ly di­s­c­ri­mi­na­ted agai­n­st?

  DE GB

  As of 1 January 2022, new regulations apply in Switzerland for outpatient services covered by mandatory health insurance (MHI). This affects all healthcare professionals, including doctors who wish to practice in Switzerland.The purpose of the new regulation is to increase the requirements for healthcare professionals and thus to improve the quality and efficiency of their services at the expense of the MHI. The purpose of these provisions is different from the obligations on the cantons to limit the number of physicians working at the expense of the MHI according to specialty or region.To understand...

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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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