On 26 July 2024, the government of Indonesia issued Government Regulation No. 28 of 2024 (“GR 28”), which is an implementing regulation of Law No. 17 of 2023 on Health (“Health Omnibus Law”). GR 28 came into effect on the day it was issued. GR 28 regulates the same main principles as the Health Omnibus Law, but adds more depth and details
On 9 July 2024, Regulation (EU) 2024/1860 amending the Medical Devices Regulation (MDR) and the In-Vitro Diagnostic Medical Devices Regulation (IVDR) was published in the Official Journal of the European Union. In particular, the new Regulation amended the provisions regarding the mandatory use of the European Medical Device Database (EUDAMED) for devices compliant with the MDR and IVDR and for legacy devices, providing for a phased implementation of the modules as they are verified and declared functional.
In a statement published on 18 June 2024, the European Medicines Agency (EMA) called on marketing authorization holders (MAHs) to adopt a Medicines Shortage Prevention Plan to reduce and prevent possible shortages and critical issues. The purpose of such a Plan is to collect information on the product, European and international marketing, supply chain vulnerabilities, measures to prevent shortages and, where appropriate, to reduce their impact on public health, and must contain appropriate measures to address shortages and mitigate their impact on patients.
Following the public hearing held on 22 May 2024, on 22 July 2024, the Italian Constitutional Court issued two judgments (judgment No. 139/2024 and judgment No. 140/2024) to decide the various appeals concerning the legitimacy of medical device payback regulation, i.e., the system under which medical device companies are required to contribute to the coverage of the NHS deficit in the years 2015-2018.
On 10 June 2024, the Member State Coordination Group on Health Technology Assessment adopted new HTA guidance on outcomes of joint clinical assessments and reporting requirements. In particular, the guidance on outcomes for clinical assessments aims at supporting both Member States’ authorities in defining the scope of such assessments and those responsible for such assessments in reporting all the elements needed by Member States to properly conduct clinical value-added analysis of health technologies at the national level.
In June 2024, the Health Sciences Authority (HSA) participated in multi-agency enforcement operations with various statutory boards to clamp down on illegal cross-border activities, including the import of illegal health products. On 25 June 2024, in a joint news release with the Singapore Police Force, Immigration & Checkpoints Authority, Central Narcotics Bureau, Singapore Customs, and National Parks Board, the HSA announced that multi-agency enforcement operations were carried out at Singapore Changi Airport. These enforcement operations were part of the authorities’ efforts to clamp down on illegal cross-border activities.
In June 2024, the Health Sciences Authority (HSA) issued an alert to members of the public not to purchase or consume three products. The HSA’s analysis of these products revealed that they contained banned or potent ingredients.
The Spanish Agency for Medicines and Medical Devices (AEMPS) has implemented a new system for the payment of clinical trial fees in Spain. The Application, which is available on the AEMPS website, facilitates the payment process and eliminates payment errors that existed in the previous system.
On 20 June 2024, a new ordinance of the Austrian minister of health regarding the stockpiling of medicinal products for human use was published in the Austrian Federal Law Gazette (BGBl II 161/2024). The purpose of this ordinance is to take preventive measures avoiding supply bottlenecks for medicinal products in Austria, ensuring sufficient supply of medicinal products at all times for the Austrian population.
On 8 July, the Singapore Food Agency (SFA) approved 16 insect species for human consumption and animal feed, including various species of crickets, mealworms and moths. The SFA has also put in place requirements that importers must adhere to for importing insects and insect products.