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.

On 17 May 2023, the European Medicines Agency published on its website some recommendations for the industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.

On 30 May 2023, the Italian Medicines Agency announced that, starting from the Scientific Technical Committee meeting in June 2023, a new simplified procedure will apply to applications for new MAs under national, mutual recognition and decentralized procedures submitted under Article 10(1) (generic medicines) and Article 10(6) (hybrid medicines) of Legislative Decree No. 219/2006 in order to streamline the relevant registration process.

On 2 June 2023, the EFPIA published on its website some recommendations aimed at improving the authorization, launch and use of digital therapies in the EU.

On 25 May 2023, the Senate approved in final form the Law converting Law Decree 34/2023, which provides a 52% discount with respect to the payback amounts requested by the Regions and Autonomous Provinces to those medical device companies which have not started litigation on the matter or which waive any ongoing litigation.

On 27 April 2023, the Italian Medicines Agency published on its website the Report on the Timelines of Pricing and Reimbursement Procedures of medicines during the period 2018-2022. The purpose of the Report is to ensure the principle of transparency of the administrative action and to inform citizens and economic operators about the timelines for access to reimbursed medicines.

On 3 May 2023, the European Medicines Agency launched a public consultation in order to review the rules on the publication of clinical trial information submitted through the Clinical Trials Information System (CTIS). The CTIS is the dedicated web portal for the submission of authorizations relating to clinical trials and their management in Europe, aimed at streamlining clinical trial applications and the supervision of clinical trials.