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Product Regulation & Liability

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In Product Regulation & Liability

United Kingdom & United States: Healthcare & Life Sciences patent enablement and what it means for your transactions or litigation

by , and 1 Min Read

The requirement that an inventor provides an enabling disclosure of their invention in exchange for patent protection lies at the heart of the patent system and is a central consideration for organizations across innovative sectors, especially those in life sciences and pharmaceuticals. This webinar delves into the dynamic landscape of patent enablement and plausibility standards, comparing and contrasting the nuanced approaches adopted in the US and Europe. In this session, we will discuss these recent developments, with a special focus on what they mean with respect to licensing, M&A and other transactions in the healthcare space and how you can anticipate issues as they arise in deals.

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Spain: 2024 is the year of consolidation of telemedicine as a result of the developments achieved in 2023

by , and 4 Mins Read

The use of telemedicine in Spain has increased in recent years, and although there is currently no national regulation in this regard, it is possible to find sectoral provisions that provide guidance for its practice. In this sense, the companies that engage in telemedicine must take into account the legal implications that may affect them, such as data protection or the treatment of patient information.

In Product Regulation & Liability

Singapore: AI takes the spotlight in the healthcare industry as Singapore focuses efforts on AI deployment

by and 3 Mins Read

The Singapore government has once again recognized the importance of AI in the healthcare industry, outlining a three-pronged approach on how to harness the potential of AI in the industry.
In the long-run, the increasing use of AI would serve to deliver better diagnosis and treatment; early detection, prevention and prediction of diseases; faster drug development; and better understand the risks around intervention and how to stratify it. In the shorter term, the use of AI may help to enhance clinical decision support; increase productivity of healthcare teams; and support individuals.

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In Product Regulation & Liability

Singapore: Health Sciences Authority provides update on electronic common technical document (eCTD) implementation

by and 3 Mins Read

The Therapeutic Products Branch of the Health Sciences Authority has provided an interim update on the progress of the eCTD implementation in Singapore following an industry consultation held between 2 May 2023 to 12 June 2023. The eCTD is a standard structured format for companies to transfer regulatory information related to therapeutic products to facilitate dossier submissions. The implementation was envisaged to take place in phases, and adoption by the industry will be on a voluntary basis during the initial roll-out.

In Product Regulation & Liability

Europe: EMA publishes its own Artificial Intelligence Medicines workplan

by , and 3 Mins Read

The European Medicines Agency (EMA) has published an artificial intelligence workplan to 2028, setting out new strategy on its use.
Taking into account the implications of AI in different areas of the healthcare sector, the EMA has focused its efforts on four dimensions that should contribute to improving the understanding and use of AI in a responsible way. The proposed workplan will be subject to future modifications as this technology evolves.

In Product Regulation & Liability

Italy: MDR Certifications – Recommendations for medical device manufacturers

by , and 2 Mins Read

On 23 November 2023, the Ministry of Health urged medical device manufacturers to speed up the process of alignment with EU Regulation 2017/745 (MDR). The Ministry of Health pointed out that, although six years have passed since the new regulations came into force, the number of certificates issued under the MDR is small compared to the number of certificates issued under the previous Directives. In addition, the Ministry of Health recalled that EU Regulation 2023/607 extended the period of validity of certificates issued under the former Directives until 21 December 2028, provided that the manufacturer submits a formal application to one of the Notified Bodies by 26 May 2024, and signs a contract with them regarding conformity assessment procedures by 26 September 2024.

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Singapore: Advertising standards watchdog finds company in breach of advertising code for greenwashing

by and 4 Mins Read

The Advertising Standards Authority of Singapore (ASAS), Singapore’s advertising standards watchdog, has found an electronics company in breach of the Singapore Code of Advertising Practice (SCAP) for greenwashing or marketing that exaggerates the sustainability of a product.
This is the ASAS’ first finding of a breach of the SCAP as a result of greenwashing. The advertising standards watchdog has previously received one other complaint about greenwashing since 2020, but the advertisement in that case was found not to have breached the SCAP.

In Product Regulation & Liability

Czech Republic: Proposed new medicinal product supply obligations and mandatory stock requirements

by and 2 Mins Read

Like many other countries in the EU, the Czech Republic has repeatedly experienced shortages in the supply of medicinal products for human use. In response to this unfavorable situation, the Government of the Czech Republic prepared and submitted for discussion to the Parliament of the Czech Republic a draft amendment to Act No. 378/2007 Sb. on Medicinal Products and on Changes to Some Related Acts, as amended.

In Product Regulation & Liability

Italy: Medical devices – The National Health Technology Assessment Program gets underway

by , and 1 Min Read

On 15 November, the Minister of Health, together with the National Agency for Regional Health Services (Agenas) and the Conference of Regions and Autonomous Provinces, presented the Italian National Health Technology Assessment Program for Medical Devices covering the years 2023-2025, that was published in the Italian Official Gazette on 15 September 2023.

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