New transparency rules related to the Clinical Trials Information System (CTIS), adopted by the Management Board of the European Medicines Agency (EMA) in October 2023, became applicable on 18 June 2024. These rules aim at striking a balance between transparency and the protection of commercially confidential information for the benefit of patients, who will have early access to key clinical trial information, of healthcare professionals, who will enjoy simplification in accessing to trial information and enrollment, and of trial sponsors, who will interact with a more user-friendly system.
On 2 March 2023, Indonesia’s Minister of Health enacted Minister of Health Regulation on Maintenance of Medical Devices in Healthcare Facilities (“MOH Regulation 15/2023”). Under the new regulation, healthcare facilities of hospitals, local governments or communities are required to allocate a certain amount of budget to carry out medical device maintenance. This new requirement is aimed to ensure the availability of medical devices that meet service standards and requirements for quality, security, benefits, safety and feasibility of use in healthcare facilities, and to ensure the safety of users, patients and the environment in healthcare facilities.
On 11 May 2024, the Ministry of Health (MOH) issued circular letter No. FR.03.01/E/884/2024. In the Letter, the MOH announced that a Good Distribution Practice for Medical Devices (Cara Distribusi Alat Kesehatan Yang Baik or CDAKB) certificate will be required as a pre-requisite for the issuance of the product registration (izin edar).
The Monetary Authority of Singapore (MAS) issued the revised Guidelines on Fair Dealing — Board and Senior Management Responsibilities for Delivering Fair Dealing Outcomes to Customers (“Guidelines”) on 30 May 2024.
This comes around 17 months after the MAS issued the Consultation Paper P013-2022, which proposed amendments to the Guidelines on Fair Dealing. The amendments widen the scope of the Guidelines to apply to all financial institutions (FIs) in relation to all products and services offered by FIs to users and prospective users, and introduce additional principles and guidance for selected areas.
The Ministry of Health (MOH) is drafting a decree on medical data management (“Draft Decree”) to establish a legal framework for (i) medical data management and development, (i) the establishment of the National Medical Database, and (iii) detailing the implementation of electronics health records and health books.
The Draft Decree is currently open for public consultation until 3 August 2024.
On June 13, 2024, the Supreme Court of the United States (SCOTUS) unanimously held in FDA v. Alliance for Hippocratic Medicine that plaintiff physicians and pro-life medical associations lacked Article III standing to challenge the U.S. Food and Drug Administration’s (FDA) regulation of mifepristone, a prescription drug primarily used in terminating pregnancy. Following the ruling, mifepristone remains available and approved. Also importantly, SCOTUS reasoned that a desire to make a drug less available for others does not establish standing to sue FDA. Since SCOTUS focused on standing as a threshold issue, the broader question of whether the FDA acted within its authority and jurisdiction to approve mifepristone remains unanswered.
The Monetary Authority of Singapore (MAS) issued the revised Guidelines on Fair Dealing — Board and Senior Management Responsibilities for Delivering Fair Dealing Outcomes to Customers (“Guidelines”) on 30 May 2024. This comes around 17 months after the MAS issued the Consultation Paper P013-2022, which proposed amendments to the Guidelines on Fair Dealing. The amendments widen the scope of the Guidelines to apply to all financial institutions (FIs) in relation to all products and services offered by FIs to users and prospective users (“Customers”), and introduce additional principles and guidance for selected areas.
On 21 June 2024, the Competition and Consumer Commission of Singapore (CCCS) issued a warning to a furniture retailer for publishing fake five-star product reviews on its website. Upon receiving complaints from customers, the CCCS launched an investigation and concluded that the retailer and two of its related companies posted the reviews. This constituted an unfair practice under the Consumer Protection (Fair Trading) Act 2003 (CPFTA).
In June 2024, the Bioethics Advisory Committee of Singapore (BAC) published a public consultation paper on the ethical, legal, and social issues arising from Human Nuclear Genome Editing (HNGE). The paper recognizes that, while developments in HNGE technologies have huge potential to improve human health, their use in research and clinical applications may have ethical, legal and social ramifications. In view of these issues, the paper seeks to obtain and discuss feedback, which will assist the BAC in developing its final recommendations to guide stakeholders in Singapore on the use of HNGE technologies in research and clinical applications.
The globalization of food supply chains, population growth, increased consumer scrutiny and technological advances over the last decade have underscored the need for specific regulatory changes in the food industry. This is particularly relevant for Asia, where analysts predict the purchasing power and middle-class population of Asia Pacific will surpass that of the US and Europe combined by 2030. Our first Food Law Guide prepared by our Sydney office in 2018 laid an exceptional foundation for this current updated version, which now covers 12 jurisdictions across Asia Pacific, including Korea. The guide provides a summary of food law regulations.