On 17 May 2023, the Belgian Medicines Agency (FAMHP) announced that marketing authorisation holders (MAHs) have three years to comply with the prohibition of “negative formulations” on the packaging of medicinal products for human use. Such negative formulations include “gluten-free”, “lactose-free”, “ethanol-free” or “no colourings” ...
In March 2022, a bill of law was introduced to amend the Sanitary Code by stating as a new requirement to carry out medical activities a civil liability insurance for damages committed during the professional practice ...
On September 17, 2022, Exempt Decree No. 63 of the Ministry of Health was published in the Official Gazette, approving Technical Standard No. 226 of the Ministry of Health, which set forth the obligation to implement a data registration system that allows the traceability of medical devices when they are received by institutional healthcare providers ...
As the latest signal in the priority of the Duty to Report in Ohio, the State Medical Board has updated its Duty to Report video.[1] The video is offered by the Board for physicians to fulfill the mandatory continuing medical education (CME) component of the license renewal process in Ohio. Introduced in a new regulation on May 31, 2021,[2] the Board began mandating one hour of CME on the topic of the legal duty to report misconduct ...
On 25 April 2023, Guernsey introduced the Preferred Debts (Insurance Policyholders) (Bailiwick of Guernsey) Amendment Ordinance, 2023. That Ordinance effects changes to the Preferred Debts Law, 1983, which accords priority to certain preferred creditors in the event of insolvency. Full details of Guernsey's insolvency regime can be found here ...
On July 14, 2023, the Ministry of Science and Technology of the PRC ("MOST") issued the Notice on Updating the Guidelines on Administrative Approval Items and the Scope and Procedures for Filing and Prior Reporting of Human Genetic Resources, which unveiled six documents, including the administrative guidelines on collection approval, biobanking approval, exportation approval and international collaboration approval of human genetic resources ("HGRs"), as well as the scope and procedures for int
On June 7, 2023, the Minister of Finance of Quebec tabled and presented Bill 30 before the National Assembly, an omnibus bill entitled An Act to amend various provisions mainly with respect to the financial sector (hereinafter the ?Bill?). The Bill includes certain amendments to the provisions of the Insurers Act (?IA?) and the Act respecting the distribution of financial products and services (?DA?) ...
The concept of "patient-centered" has become the core guiding principle in current research and development ("R&D") of drugs. "Patient-centered" drug R&D refers to the process of drug discovery, design, implementation and decision-making based on the patient's point of view, with the aim of efficiently developing clinically valuable drugs that better meet the needs of patients ...
Recently, China's healthcare industry has been subject to a rigorous inspection and rectification initiatives focusing on anti-corruption. These initiatives have attracted widespread attention in the industry, and we have received numerous media and customer inquiries regarding such issues ...
On September 8, 2023, the China National Center for Biotechnology Development (the "CNCBD"), a public institution under direct charge of the China's Ministry of Science and Technology (the "MOST"), released the"Notice on Issuing Answers for Frequently Asked Questions on Human Genetic Resource Administration"(the "Updated FAQs"), which summarized and responded to questions that are constantly raised among the relevant industry (the "Industry") ...
On September 7, 2023, the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration (the"NMPA") released "Annual Report on Progress of Clinical Trials for New Drug Registration in China (2022)"(the"2022 Annual Report") ...
On September 28th, Law 21,614 of the Ministry of Labor and Social Security was published in the Official Gazette (hereinafter the “Law”), which establishes amendments to Law No.21,063, which Creates an Insurance for the Accompaniment of Children Suffering from Diseases as Indicated and Modifies the Labor Code for these purposes (hereinafter “SANNA Law”) ...
A patent landscape provides a bird?s-eye view of the patenting activity related to a specific technology. It can be an invaluable tool for your organization as the analysis of patent data reveals business, scientific and technological trends. Indeed, many industries increasingly rely on patent landscapes to provides a basis for understanding innovation activity in their field ...
On October 8, 2023, theScientific and Technological Ethics Review Regulation (Trial)("Scientific and Technological Ethics Regulation") was jointly published by the China's Ministry of Science and Technology ("MOST"), the Ministry of Education, the Ministry of Industry and Information Technology, and other seven (7) departments/institutions, which was followed by a press conference held next day by the MOST to respond to media inquiries ("Press Conference") ...
The European Commission published a draft proposal for a revised Product Liability Directive (the “PLD Proposal”) on 28 September 2022, which aims to bring the European Union’s product liability regime ‘up to speed’ with the digital age, circular economy business models and global value chains. This blog focuses on the main changes the PLD Proposal brings and its impact on life science companies ...
Module 5 will assess the robustness and effectiveness of procurement processes, the adequacy of items obtained (including their specification, quality, and volume) and the effectiveness of their distribution. It will also consider the UK-wide procurement of lateral flow and PCR tests. The provisional scope for this module lists three key areas of investigation ...
This week marks National Fertility Awareness Week in the UK. This annual event, organised by Fertility Network UK, a national charity dedicated to supporting individuals on their fertility journeys, aims to change perceptions and raise awareness for those undergoing fertility treatment. The theme for this year is "Forward4Fertility," emphasising progress and inclusivity in the journey towards parenthood. The staggering fact that over 3 ...
As a part of our conversation with clients webinar series, Helen Wilson, Head of Legal at Weetabix joined Sebastian Price, Partner at Shoosmiths to talk about her experience of career development including success insights, job changes, individual versus organisational impact on progression and more ...
On September 29, 2023, Decree No. 4, dated January 25, 2023 (the "Regulation"), issued by the Ministry of the Environment (the "Ministry"), was published, coming into force the Emission Compensation System for stationary sources subject to Green Tax[1] (the “System”). The System promotes the development of emission reduction projects (the "Projects") ...