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 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.