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Product Regulation & Liability

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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.

By means of Resolution No. 12/2024, published in the Official Gazette on 24 April 2024 (“Resolution”), the Secretariat of Industry and Commerce amended the regime of advertising of goods and services involving an offer to an undetermined audience; it also repealed Resolution No. 915/2017. The Resolution’s main purpose is to modify the regulations governing advertisements so that they are clearer, more understandable, and useful for consumers. The aim is to simplify the current regime and prevent consumers from being “over-informed,” which could make it difficult for them to make appropriate purchasing decisions.

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.

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…