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.
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.
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.
The Aesgp (Association of the European Self-Care Industry), Efpia (The European Federation of Pharmaceutical Industries and Associations) and Medicines for Europe have published a position paper containing a set of recommendations on how to make package leaflets for medicines more comprehensible to patients in order to ensure their appropriate, safe and effective use.
The Constitutional Court has set the public hearing for 22 May 2024, to discuss the legitimacy of the payback regulation for medical devices. Hundreds of manufacturers of medical devices are awaiting the Constitutional Court’s decision, since, should the Court confirm the legitimacy of the legislation in question, they will be required to pay EUR 1.1 billion on account of the expenditure overruns for the four-year period 2015-2018, in addition to the payback due for the following years.
On 23 April 2024, the Federal Senate approved Bill 6,007/2023, which originated as Bill 200/2015, and which generated intense debate among all those involved in the clinical research ecosystem. While the bill was supported by the economic sectors and part of academia due to the stability and security it brings to clinical research in Brazil, various social segments, part of academia and government authorities who are members of the system raised concerns about the possibility of weakening national ethical guidelines and dismantling the CEP/CONEP system.
On 28 March 2024, the Health Sciences Authority released updates to the registration of therapeutic products as part of its continued efforts to improve regulatory efficiency and enhance clarity in the regulatory requirements and processes.