The new Clinical Trials Regulation became applicable on 31 January 2022, following achievement of the full functionality by the new Clinical Trials Information System, bringing more transparency into the area of clinical trials.
With judgment No. 2149 dated 19 January 2022, the Court of Cassation acknowledged the liability of a manufacturer of medical devices for damages suffered by a patient due to their medical devices breaking during surgery.
On 23 March 2022, the “National Ethics Committee for trials conducted by public research organizations and other public organizations of a national nature” (“National Ethics Committee”) was established within the National Institute of Health (NIH) in accordance with the provisions of the decree of the Ministry of Health dated 1 February 2022. The National Ethics Committee was settled on 23 March at the Italian NIH to replace the Ethics Committee of the NIH, which has been in office until now.
On 16 February 2022, the Decree of the Ministry of Health dated 30 November 2021 governing the assignment for registration and commercial purposes of data relating to nonprofit clinical studies (“Decree”) was published in the Official Gazette. Said Decree repeals the previous Ministerial Decree dated 17 December 2004.
On 18 March 2022, the National Agency for Regional Health Services (Agenas) published a notice to collect proposals for public-private partnerships aimed at awarding the concession for the design, implementation and management of the national platform for telemedicine provided for by the “Health” mission of the National Recovery and Resilience Plan.
On 16 February 2022, the European Commission published the final version of Annex 21 to the Good Manufacturing Practice (GMP) Guidelines governing the importation of medicinal products, which will enter into force on 21 August 2022.
The guide provides the latest developments and updates to in-house counsel and business executives on: regulations and compliance; clinical trials; marketing, manufacturing and distribution of pharmaceuticals and medical devices; pricing; digital health; patents; and COVID-19.
On 20 April 2022, the French government adopted an ordinance adapting French law to EU Regulation 2017/745 on medical devices (MDR). Although the MDR is directly applicable since its entry into force on 26 May 2021, adaptations of the provisions of the French Public Health Code were necessary and much awaited by the medical device industry.
In its recent judgment (24 March 2022 – C-533/20, Somogy Megyei Kormányhivatal/Upfield Hungary Kft.), the European Court of Justice has decided how specific the labeling of vitamins in the list of ingredients of food must be. The court ruled that indicating the specific vitamin formulation (e.g., “cholecalciferol”) is unnecessary. Rather, using the more general name of the vitamin such as “Vitamin D” in the list of ingredients is sufficient. In addition, the judgment of the court can be understood in such a way that indicating the more complex vitamin formulation in the list of ingredients might even be prohibited.
On 22 March 2022, the Ministry of Science and Technology of the People’s Republic of China issued Draft Implementation Rules of the Administrative Regulations on Human Genetic Resources for public comments until 21 April 2022. The Draft Rules provide clarifications and operational details on the Administrative Regulations on Human Genetic Resources promulgated in 2019.