Search for:
Category

Submenue

Category
In Product Regulation & Liability

Italy: Publication of the proposal for the revision of the EU pharmaceutical legislation

by 2 Mins Read

On 26 April 2023, the European Commission presented its long-awaited proposal for the review of the pharmaceutical legislation. The main objectives of the proposal include the creation of a Single Market for medicines aimed at ensuring that all patients across the EU have timely and equitable access to safe, effective, and affordable medicines; the offering of an attractive and innovation-friendly framework for research, development, and production of medicines in Europe; the drastic reduction of the administrative burden by speeding up procedures significantly, reducing authorization times for medicines, so they reach patients faster; and the enhancement of the availability of medicines.

Read More
In Antitrust / Competition

United Kingdom: Introducing Regulation of Digital Platforms and New Competition and Consumer Protection Reforms

by and 1 Min Read

The UK Government published on 25 April 2023 its long-awaited Digital Markets, Competition and Consumers Bill. The Bill introduces radical new digital sector regulation – akin to the EU’s Digital Markets Act – in addition to expanding the UK Competition & Markets Authority’s consumer protection powers and introducing significant reforms for the UK competition regime.

In AML & Financial Services Regulatory

Thailand: Digital Onboarding –  Navigating AML Compliance and Technology Laws

by and 2 Mins Read

This event will be held on Wednesday, 24 May 2023 from 14:30-16:00 hrs. (Bangkok time) via Zoom and YouTube Live. This exclusive webinar presented by our professionals will explore: (i) overview of the legal issues surrounding digital onboarding process, (ii) key concepts of the Anti-Money Laundering / Countering the Financing of Terrorism (AML/CFT) laws and specific regulations governing digital onboarding, (iii) key concepts of technology laws and regulations relating to digital onboarding, and (iv) case study: an end-to-end flow of the digital onboarding process for FinTech businesses. The webinar will be conducted in Thai.

In Product Regulation & Liability

EU: A New Dawn for the Pharma Regulatory Regime?

by 5 Mins Read

On 26 April 2023, the European Commission finally published its Proposal to revise the EU Pharmaceutical legislation, the most momentous reform for over 20 years. This is an eagerly anticipated overhaul of the EU’s pharmaceutical system that has generated a lot of debate and concern since earlier leaked documents showed the far-reaching effect of the measures that were being considered and the impact these could have on the industry. The review is part of the EU’s Pharmaceutical Strategy for Europe, and its aim is to make medicines more available, accessible and affordable whilst at the same time supporting innovation and boosting the competitiveness of the EU pharmaceutical industry.

In AML & Financial Services Regulatory

Argentina: New requirements for access to the foreign exchange market

by 3 Mins Read

On 20 April 2023, the Central Bank of Argentina issued Communication “A” 7746 introducing modifications to the access to the foreign exchange market for the payment of certain services abroad. Communication “A” 7746 determines that the prior approval of such entity will be required to make certain payments abroad, provides a term of 180 calendar days for the sworn statements for transactions with securities, and extends the list of persons and entities that may access a special remunerated account based on the evolution of the reference exchange rate of Communication “A” 3500.

Read More
In AML & Financial Services Regulatory

Singapore High Court holds mere buying and selling of cryptocurrency does not contravene licensing provisions under the Payment Services Act

by and 6 Mins Read

Singapore High Court in Rio Christofle v Malcolm Tan Chun Chuen [2023] SGHC 66 concludes that the bona fide buying and selling of cryptocurrency without a licence or exemption is not to be a contravention of licensing provisions where there is no “carrying on a business of providing any type of payment service”. Three indicia suggest that a person is carrying on a business of providing a payment service: (1) whether profit has been made; (2) the number of transactions in question; and (3) whether the person is acting as an intermediary.

In Product Regulation & Liability

United States: FTC puts companies on notice that failure to provide support for their product claims could result in civil penalties

by 3 Mins Read

On 13 April 2023, the Federal Trade Commission (FTC) issued a letter containing a Notice of Penalty Offenses Concerning Substantiation of Product Claims to approximately 670 advertisers, putting each company on notice that deceiving consumers with advertisements that make unsubstantiated product claims could subject the company to civil penalties of up to USD 50,120 per violation under 15 U.S.C. § 45(m)(1)(B).

In Product Regulation & Liability

United States: FDA Issues Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning

by , and 1 Min Read

On 3 April 2023, FDA issued a draft guidance for industry, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions, for manufacturers whose medical devices use machine learning technologies to improve patient care. Through the draft guidance, FDA intends to provide a least burdensome approach to support iterative improvements to machine learning-enabled device software functions or ML-DSFs through modifications, while continuing to provide a reasonable assurance that the device is safe and effective. In essence, manufacturers can proactively seek FDA’s concurrence with the intended modifications to the applicable devices without additional marketing submissions for each modification in the future.

Read More
Load More