The new legislation about “Discipline of the therapeutic use of an investigational medicinal product” (Ministerial Decree September 7, 2017) which abrogates the Decree 8 May 2003 as amended, was published in the Italian Official Journal on November 2nd 2017 and will enter into force 30 days after the publication.
The new Decree contains important updates including:
- The possibility to request a compassionate use for medicinal products already authorized but not yet available on the Italian market.
- In case of rare diseases or rare tumors, the possibility to base the compassionate use request on the results of Phase I clinical trials that have proven the activity and the safety of the medicinal product at a specific dose/therapeutic regimen even in therapeutic indications other than the concerned one.
- The introduction of a new submission procedure with the request to be submitted by the physician(s) to the Ethics Committee (EC) only; then the opinion issued by the EC will be electronically forwarded to AIFA within 3 days as of the opinion date.
- The requirement for the company to previously inform AIFA about the starting date of the compassionate use program and the estimated duration of the free of charge supply of the concerned medicinal product.
- The inclusion of the Pharmacovigilance requirements provided for in Ministerial Decree 30 April 2015.
Regulatory Pharma Net team and experts are available to support companies to comply with the new requirements.