To promote and support research and development of medical devices in Thailand, the Ministry of Public Health and the Food and Drug Administration have recently issued several notifications providing additional guidance for manufacturers or importers of certain medical devices seeking exemptions from licensing requirements (i.e., the manufacturing or import license, and the product registration license) under the Medical Device Act.
On 22 May 2024, the Italian Constitutional Court held a public hearing to discuss the issue of the legitimacy of medical device payback regulation, as raised by the Lazio Regional Administrative Court, for conflicting with Articles 3, 23, 41, and 117 of the Constitution.
The European Medicines Agency’s Medicines Shortages Steering Group recently developed a list of recommendations in hopes of increasing the availability of critical medicines flagged for supply chain vulnerabilities or risks.
The European Parliament has adopted the new AML/CFT legislative package, which aims to comprehensively strengthen the EU rules to fight money laundering and terrorist financing, including the establishing of a new EU authority to supervise directly the riskiest entities, an EU limit on large cash payments up to EUR 10,000, and more detailed, directly applicable rules regarding customer due diligence and beneficial ownership.
On 6 May 2024, the Federal Government published Federal Law No. 14.852/2024, which established the Legal Framework for the Electronic Games Industry in Brazil. The new law sets out the basic principles and rules for the development and sale of electronic games in Brazil. It establishes guidelines on the manufacture, import, marketing, development and commercial use of electronic games, in addition to providing that the State must establish the indicative age classification. Therefore, it provides a specific framework for this sector in Brazil and ensures the protection of its consumers and users.
The Superintendence of Companies, through its External Circular No. 100-000003 of 23 April 2024 (hereinafter the “Circular”), extended the deadlines for the Chambers of Commerce and Foreign Non-Profit Entities (in its acronym in Spanish “ESALs”) to implement the Integral Self-Control and Risk Management System of money laundering, terrorism financing and financing of the proliferation of weapons of mass destruction and Business Transparency and Ethics Programs. The new deadline is on 31 May 2025.
On 14 May 2024, the European Securities and Markets Authority (ESMA) published guidelines on fund names using environmental, social and governance (ESG) or sustainability-related terms. The main purpose of these guidelines is to enhance investor protection with regard to funds named in ways suggesting an investment focus in companies that meet certain sustainability standards. Against this backdrop and after the public consultation launched on 18 November 2022, ESMA clarifies what investors may expect in terms of policies, practices and characteristics of funds consistent with sustainability standards, as also the circumstances where a fund name with ESG or sustainability-related terms is indicative of unfair, unclear or misleading practices.
In April 2024, the Anti-Money Laundering Office (AMLO) issued five Guidelines on Customer Due Diligence (“Guidelines”), tailored for five categories of businesses, to elaborate on the recommended practices under the Ministerial Regulation on Customer Due Diligence, B.E 2563 (2020). The new Guidelines, issued in April 2024, target certain businesses classified as “reporting entities” under sections 3 and 16 of the Anti-Money Laundering Act, B.E. 2542.
On 10 April 2024, the European Parliament, in a plenary session, approved new proposals for a directive and regulation on medicinal products for human use. The two texts will now have to be approved by the European Council. These proposals aim at ensuring safer, more efficient, and high-quality medicines for EU citizens, at promoting innovation and development of medicines to address unmet medical needs, and at strengthening the research on new medicines to tackle antimicrobial resistance.
On 18 April 2024, the State and Regions’ Conference approved the Agreement proposed by the Ministry of Health for the implementation of an active pharmacovigilance program.
The Agreement will be implemented by signing conventions between the Italian Medicine Agency (AIFA) and single Regions, through which the Pharmacovigilance Funds, relating to the years 2018, 2019, 2020, 2021 and 2022, will be disbursed, for an overall total of EUR 58.5 million.