Gustave Roussy is among the French hospitals authorised to produce Special Hospital Preparations. This accreditation, granted by ministerial decree and published in the Official Journal on 18 September, allows the Institute’s hospital pharmacy to develop and manufacture, subject to approval of each individual preparation, medicines that are unavailable either because of supply shortages or because the pharmaceutical company previously marketing them has discontinued production.

A response to medicine shortages

The possibility for hospital pharmacies to manufacture Special Hospital Preparations was introduced by the 2022 Social Security Financing Act to replace medicines affected by supply shortages. As highlighted by the French Directorate for Research, Studies, Evaluation and Statistics (DREES) in a report  published in March 2025, “production constraints affecting medicines of major therapeutic interest increased at an unprecedented rate between 2021 and 2023”, while the number of reported shortages “tripled” between 2017 and 2022.
Gustave Roussy is now authorised to manufacture medicines of major therapeutic interest facing supply difficulties, as identified by the ANSM or the Ministry of Health. These Special Hospital Preparations differ from the medicines routinely prepared in hospital pharmacies, such as chemotherapy treatments tailored for individual patients. Instead, they are manufactured in batches according to monographs published by the ANSM, to which authorised institutions contribute through the development of formulations, quality control methods and stability data.
Teams at Gustave Roussy are already working with the ANSM on a first Special Hospital Preparation: an oral suspension of aprepitant for children, intended to prevent chemotherapy-induced nausea and vomiting.

Rare expertise serving patients

Obtaining this accreditation required compliance with a stringent set of specifications covering manufacturing and quality control equipment, staffing expertise and quality assurance capabilities.
This authorisation recognises the expertise that Gustave Roussy’s clinical pharmacy teams have built up over many years. The Institute was already producing hospital preparations of innovative medicines when no industrially manufactured option was available to patients in France. This has notably been the case for birabresib, intended for patients with NUT carcinoma, and ONC201, an innovative treatment for certain particularly aggressive rare brain tumours.

•    Read more about birabresib.
•    Read more about ONC201.

“For patients, this accreditation means they can continue to receive their treatment despite supply shortages. It strengthens Gustave Roussy’s ability to provide rapid access to the therapies patients need, precisely when they need them," — Professor Bernard Do, Head of the Clinical Pharmacy Department at Gustave Roussy.