Recently, the National Medical Products Administration (the "NMPA") issued the "Pilot Work Plan for the Segmented Production of Biological Products" (the "Pilot Plan"), introducing a pilot initiative for the segmented production of biological products. This represents a breakthrough in the regulation of segmented production, a long-awaited achievement in the biopharmaceutical industry ...
PROOF OF INCAPACITY: ANALYSIS OF CIUSSS DE L?OUEST-DE-L?LE-DE-MONTREAL (ST. MARY?S HOSPITAL CENTER) v. RC 1 Summary The authors comment on this decision rendered on September 20, 2024, in which the Court of Appeal ruled on the capacity to consent to care in the presence of a psychiatric disorder ...
In a long-awaited decision, the Pennsylvania Supreme Court has held that “direct physical loss” language in commercial property policies is not ambiguous and that COVID-related business-interruption claims do not trigger the insuring clause of these policies. Based on this ruling, business interruption claims filed for losses caused by pandemic-related closures are not covered under standard commercial property policies ...
On September 8, 2024, the Ministry of Commerce, together with the National Health Commission and the National Medical Products Administration (hereinafter referred to as the "Three Departments"), publicly issued theNotice on Carrying Out Pilot Programs to Expand Opening-Up in the Healthcare Sector(hereinafter referred to as the "Notice"), announcing that,effective immediately, foreign-invested enterprises are permitted to engage in the development and application of human stem cells, gene diagno
On August 28, 2024, the National Medical Products Administration (NMPA) released the Medical Device Administration Law (Draft for Comment) (hereinafter referred to as the "Draft") for public comments ...
China's pharmaceutical industry is witnessing a notable surge in "pipeline spin-off projects", a model commonly referred to as the "Spin-off-NewCo" or "SON" model. Within the past two months, we've been advising on nearly ten SON projects. Leading pharmaceutical companies in China are more frequently adopting the SON model to separate parts of their pipelines into new, independent companies ...
Introduction The EU Deforestation Regulation (‘EUDR’) waspublishedin the Official Journal on 9 June 2023 and entered into force on 29 June 2023,marking the start of its implementation phase. As the EU legislator has adopted a decentralized enforcement approach, Member States need to set up the necessary legal frameworks to fulfil their enforcement duties under the EUDR ...
In recent years, the regulatory framework for human genetic resources ("HGR") in China has become increasingly mature ...
China's National Medical Products Administration (NMPA) released the 2023 Drug Review Annual Report on its official website on February 4, 2024, closely followed by the 2023 Medical Device Registration Annual Report on February 5. According to the public information, more than 60 innovative drugs have been approved by NMPA from 2022 to 2023, and a total of 61 innovative medical devices have been approved in 2023 ...
On 21 September 2023,the EU Court of Justice (‘CJEU’) handed down its ruling in the Apotheke B. case (C-47/22), and it is a good example of the high threshold set by the EU Court of Justice to uphold the Community Code’s main aim of protecting public health ...
For the past five years there has been an ongoing battle between the Belgian Competition Authority (“BCA”) and the legislator about the BCA’s competence to review mergers between hospitals. This wrangling has lead to a whole collection of legislative reforms, opinions, merger decisions with strong press releases, and communications going back and forth ...
In recent years, license-in/out transactions have become the most common way for innovative drugs and medical devices (including medical aesthetics) companies to collaboratively develop and commercialize medical products and related technologies. According to public information, in China, the total amount and number of investment and financing in life sciences sector have witnessed a significant decline from 2021 to 2023, with the investment amount being only a quarter of that in 2021 ...
From Dominic Cummings to Nicola Sturgeon, 2023 was a noisy, headline-grabbing year for the UK’s public inquiry into the Covid-19 pandemic. What’s coming in 2024? And what does it mean for businesses? In terms of media exposure, the first full year in the life of the UK’s official Covid-19 Inquiry was a resounding success ...
The case concerns the interpretation of Article 269 of the AHL, which provides that additional or more stringent measures by Member States may be adopted concerning responsibilities for animal health in certain limited areas. (As provided for Articles 10 to 17 AHL ...
The transformational power of AI is set to redefine the modus operandi across various sectors, including healthcare. The life sciences sector in particular are already realising the benefits of AI. Their shared experiences offer other health organisations the opportunity to pre-empt some of the challenges associated with AI. The rapid and profound impacts emerging from AI advancements are truly staggering, leaving no room for delay ...
Belgium is welcoming a significant development in the field of veterinary medicine law. The Act of 11 July 2023 containing various provisions on health, which entered into force on 8 September 2023, introduces changes across a wide spectrum of healthcare domains, which are encompassed in approximately 20 chapters. In this blog post, we provide an overview of the key changes related to the marketing of veterinary medicines set out in Chapters 4 and 14 of the new Law ...
In the fourth quarter of 2023, Sen. Raphael Warnock, D-Ga., made industry news, important banking and financial rule changes were implemented, and Georgia's Department of Banking and Finance quietly issued important new regulatory guidance on a handful of topics. Warnock Addresses Banking Committee, Introduces Legislation First, during a three-plus hour U.S ...
Social determinants (or drivers) of health (SDOH) can create substantial barriers to an individual’s overall health and wellbeing. For example, several factors associated with economic hardship—lack of transportation, safe housing, or access to nutritious food, etc.—are highly correlated with poor health outcomes ...
Driven by the passion and belief, and fraught with various risks and challenges, the research and development of innovative drugs and medical devices is a journey that's never easy. Along the journey, an individual may stride resolutely, yet with companionship, two can traverse faster and farther ...
By: Daniel Silva, Sanjay Bhandari, and Manisha Malhotra The Paycheck Protection Program (“PPP”) emerged as a lifeline for small businesses grappling with the unprecedented challenges of the COVID-19 pandemic. Lenders navigated a landscape of regulations that Congress quickly drafted in response to the pandemic. These regulations and obligations evolved, subtly yet materially, from the first and second rounds of PPP “draws ...
Updated on 8 January 2024.Food law is extensively harmonized throughout the EU, but national law still has a role to play. In this short article, we look at three developments in Belgian food law that have taken place in 2023: the amendments to the Food Safety Agency’s administrative fining regime, the introduction of nutrivigilance, and the announced revision of the food hygiene legislation.1 ...
Both the Belgian legislator and government have played an active role in 2023 when it comes to pharma legislation, which has led to a number of changes in the legal framework. In this article, we look back and discuss five noteworthy developments in Belgian pharma law. 1 ...
Module 6 of the UK’s Covid-19 Public Inquiry opened on 12 December 2023, with public hearings set to begin in Spring 2025. This article explores what Module 6 will examine and explains how and why members of the Care Sector may want to become involved ...
There was considerable anticipation regarding whether the negotiations would be successfully concluded during this meeting. Without an agreement, there was a risk of significant delays in the adoption of the framework. This was undesirable for EU institutions that have invested considerable prestige in leading the regulation of AI globally. Read more about the most contentious issues leading up to the last negotiation meeting in this article ...
