We are pleased to present you with the latest update of Product Risk Radar (linked to https://www.globalcompliancenews.com/product-risk-radar/), our online content hub that covers the latest important legal developments in product regulatory and liability risk. The diverse range of articles helps you navigate the increasingly challenging landscape of the newest legal…
The Thai Food and Drug Administration (FDA) has recently issued two notifications, namely the Notification of the Ministry of Public Health Re: Good Manufacturing Practice, B.E. 2566 (2023), and the Notification of the Ministry of Public Health Re: Good Importing and Sales Practice, B.E. 2566 (2023). These notifications aim to regulate the quality systems of medical device manufacturing facilities, as well as importers and sellers of medical devices.
The Government of Catalonia has recently published a guide on the advertising of medicinal products for human use. This guide provides new and updated advice on the understanding of the regulations on advertising on medicinal products. In particular, it focuses on advertising in the digital environment, analyzing the use of digital platforms and tools and providing recommendations for responsible advertising in accordance with the current sectorial regulatory framework.
The Italian Medicines Agency has summarized the distribution methods that can be applied in the event of shortages of drugs included in transparency lists. These measures can be implemented in order to guarantee pharmaceutical assistance at the regional level, avoid charges to citizens and optimize economic resources.
The EU Court of Justice, in its judgment given in Case C-291/22 P, annulled the European Medicines’s decision denying marketing authorization for a drug, finding that the evaluation process was vitiated by the presence within the Committee for Medicinal Products for Human Use of an expert who was in a situation of conflict of interest.
From governments to private investors, big pharma to biotechs, organizations inside and outside the region are reimagining healthcare and life sciences to improve access, outcomes and affordability. This requires capital investment, collaboration and change at levels rarely seen before. In our digital campaign, we explore this dynamic through two main themes and identify six key market opportunities.
On 12 March 2024, the Cabinet approved in principle the draft Alcoholic Beverage Control Act (No..), B.E. (“New Alcoholic Beverage Bill”) as proposed by the Ministry of Public Health. The New Alcoholic Beverage Bill has now been forwarded to the Office of the Council of State for further consideration.
On 11 March 2024, Minister of Interior Decree No. 16/2024 (III. 11) on the issuance of the list of strategic medicinal products (“Decree”) was published. The Decree introduces a new stockpiling obligation on medicinal product wholesale license holders.
The Competition and Consumer Commission of Singapore commenced an investigation under the Consumer Protection (Fair Trading) Act 2003 (CPFTA) against a water filtration system supplier (“Supplier”) for unfair practices between September 2021 and November 2023.
The Supplier was found to be making false claims about its sales kit, misleading promotion listings, and misleading claims on the health benefits of alkaline or filtered water, from its website and social media pages.
Our popular Annual Compliance Conference, which attracts over 4,000 in-house senior legal and compliance professionals every year from across the world, will be taking place from 30 April – 6 June. We will be delivering our cutting-edge insights and guidance virtually on key global compliance, investigations and ethics trends.