On 5 October 2023, the European Medicines Agency amended its transparency rules on the publication of information on clinical trials submitted through the Clinical Trials Information System. This adjustment was made at the end of the public consultation, launched between May and June, to record stakeholders’ impressions and opinions a few months after European Regulation no. 536/2014 on clinical trials came into effect.
On 17 August 2023, the Ministry of Health published the draft decree, and related technical regulations, on the “Transparent Healthcare” public register and launched a public consultation to gather comments and contributions from stakeholders, including manufacturers of health products, healthcare professionals and organizations.
On 21 July 2023 the Ministry of Health published on its website new guidelines on the advertising of over-the-counter (OTC) and prescription-free medicinal product (SOP).
In the Official Journal of 13 June 2023, the Decree of the Ministry of Health dated 12 April 2023 governing the national administrative procedures for the submission of clinical investigation applications for devices that are not CE-marked and CE-marked but used outside their intended use and the Decree of the Ministry of Health dated 12 April 2023 governing the national administrative procedures for the submission of clinical investigation applications for CE-marked devices used within their intended use were published. These decrees are provided for in article 16, paragraphs 2 and 3 of Legislative Decree No. 137/2022 issued to bring national legislation in compliance with the provisions of Regulation (EU) 2017/745.
On 27 June 2023, the Italian Medicines Agency (AIFA) announced the release of new features for the e-Dossier Price and Reimbursement web portal. The portal, available at the AIFA Services Portal, enables the preparation of dossiers in digital format to support reimbursement and price claims.
On 22 June 2023, the Court of Justice of the European Union ruled in the Joined Cases C-6/21 P and C-16/21 P on the impartiality requirement of the scientific committees’ members and experts involved in the European Medicines Agency’s activities.
On 23 June 2023, EMA’s GCP Inspectors Working Group updated the Q&A on Good Clinical Practices. In particular, the update has allowed for the possibility, if in compliance with applicable European regulations and the requirements of ICH E6 guideline, that the sponsor may support the investigator by identifying or contracting service providers or personnel to be directly involved in the conduct of the clinical trial (e.g., by providing additional resources to the clinical trial site or qualified personnel).
In the Official Gazette of 14 June 2023, the Decree of the Ministry of Health of 20 March 2023 regulating the requirements of facilities suitable for conducting clinical investigations and the Decree of the Ministry of Health of 20 March 2023 introducing provisions to ensure that persons in charge of evaluating and validating clinical investigation applications do not have a conflict of interest, are independent of the sponsor, the investigators involved and the natural or legal persons financing the clinical investigation, and are free from any undue influence were published. These decrees, which are immediately applicable, are provided for in article 16, paragraphs 5 and 8 of Legislative Decree No. 137/2022.
With judgment No. 8656 published on 22 May 2023, the Administrative Court of the Lazio Region ruled on the legitimacy of the decision whereby the AIFA rejected an application for the renewal of a Parallel Import Authorization filed by a pharmaceutical company that had carried out re-packaging operations consisting in the opening of the aluminum envelopes containing the blisters and the removal of one tablet per blister.
In the context of the conversion into Law of the Law Decree No. 51/2023, the Chamber of Deputies approved an amendment extending the payment of payback amounts due by medical device companies from 30 June to 31 July 2023. The amended text, on which the Chamber of Deputies was asked for a vote of confidence, received the majority of affirmative votes and has now been transmitted to the Senate.