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Product Regulation & Liability


On 18 January 2024, the World Health Organization issued new guidance on the ethics and governance of artificial intelligence for health, focusing on large multimodal models (LMMs). The WHO guidance summarizes the broad applications of LMMs in the healthcare industry and includes recommendations for governments, which have the primary responsibility of setting standards for the development and deployment of LMMs, and their integration and use for public health and medical purposes.

On 15 January 2024, the Decree of the Minister of Health No. 3 of 8 January 2024 on “Changes to the regulation on the organization and functioning of the Italian Medicines Agency” was published in the Official Gazette. The Decree will enter into force on 30 January 2024. The Decree provides, amongst other things, for the abolition of the role of General Director (while the position of the President as the body and legal representative of the Agency is maintained) and the creation of the management positions of the Administrative Director and the Technical-Scientific Director.

After the Conference on Emerging Biotechnology held on 14 November 2023, the Ministry of Foreign Affairs launched a round table for the internationalization of the biotechnology sector, which met for the first time on 9 January 2024. The round table was established in order to identify strategies and provide recommendations for those working in the field of biotechnology, with the aim of strengthening the national sector and stimulating the development of innovative supply chains and emerging technologies.

On 15 January 2024, Consip S.p.A. and Confindustria Dispositivi Medici (the Italian Association of Medical Device Companies) signed an institutional collaboration agreement aimed at identifying the best procurement opportunities for public administrations in the healthcare sector.

On 21 December 2023, the Italian Medicines Agency updated the operating instructions and forms that can be used for the submission to the Biological Medicinal Product Evaluation Office of the documentation regarding the import and the export of human blood and blood components.

On 18 January 2024, the World Health Organization (WHO) published a New Guidance on the ethics and governance of large multi-modal models (LMMs) of Artificial Intelligence (AI), targeting governments, technology companies and healthcare providers to promote the appropriate use of AI and protect public health.

The Doing Business in the Philippines handbook aims to equip both local and foreign entrepreneurs with a practical guide to navigating the ever-evolving business landscape in the Philippines. It provides information on the requirements needed when setting up and operating a business in the Philippines, including incentives under special registrations, taxation, employment, IP, dispute resolution, and industry-specific regulations.

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.