On 6 March 2023, FDA issued a Dietary Supplement Ingredient Directory. The Directory is hosted on the agency’s website and is intended to help the public quickly find what the FDA has said about a specific ingredient and whether the agency has taken any action with regard to the ingredient. Importantly, the Directory will replace the previous FDA Dietary Supplement Ingredient Advisory List, which listed ingredients identified by the agency as not lawfully marketed in dietary supplements.
A series of briefings that take a bite-size look at international trends in different jurisdictions, drawing on Baker McKenzie’s expert financial services practitioners with local market knowledge. This edition takes a bite-size look at the latest environment, social and governance developments in Brazil, the European Union, Belgium, Hong Kong SAR, Japan, Singapore, Thailand, and the United Kingdom.
The Monetary Authority of Singapore issued the Notice on Business Conduct Requirements for Corporate Finance Advisers on 23 February 2023. This comes around 14 months after the MAS issued the Consultation Paper P020-2021 which proposed to introduce regulatory requirements on the conduct of due diligence by corporate finance advisers, strengthen public confidence and promote informed decision making by investors through quality disclosures.
With Decision No. 131, published on 4 January 2023, the Council of State ruled on the possibility for pharmaceutical companies to know in advance the data used by the Italian Medicines Agency for the calculation of the pharmaceutical payback.
On 3 February, the European Medicines Agency, the Heads of Medicines Agencies and the European Commission launched a public consultation on the establishment of a multi-stakeholder platform to improve clinical trials in the European Union.
On 19 January 2023, the Court of Justice of the European Union specified that Art. 2(2) of Directive 2001/83/EC, pursuant to which, in case of doubt on the classification of a product as a medicine or a medical device, the provisions on medicinal products shall apply, covers both “medicinal products by function” (i.e., substances exerting pharmacological, immunological or metabolic action) and “medicinal products by presentation” (i.e., substances presented as having properties for treating or preventing disease).
With the entry into force of Regulation (EU) 2019/1009 on fertilizer products, the regulatory framework for fertilizer products within the European Union has been updated. However, national regulations may continue to be used on an optional basis. This Regulation has extended the categories of fertilizers covered and it also provides for a number of obligations for manufacturers, importers and distributors of fertilizers, including the declaration of conformity and the CE marking. Finally, guidelines have also been established for the conformity assessment of these products.
On 20 February 2023, the Health Sciences Authority announced that it had seized over 737,000 units of illegal health products worth SGD 640,000 in 2022 through enforcement raids and covert purchases. Illegal health products include unregistered or counterfeit health products, as well as products with potent medicinal ingredients and/or banned substances illegally added to them.
On 15 November 2022, the National Assembly of Vietnam passed the new law on anti-money laundering which will replace the current law from 1 March 2023. Reporting entities as covered in the new law should take into account certain key changes in anti-money laundering regulations.
As part of the government’s efforts to improve the visibility of medical devices security, raise overall cyber hygiene levels and better secure Singapore’s cyberspace, the Cybersecurity Labelling Scheme for Medical Devices was announced in 2022.