At the beginning of March Fimea launched a new pilot program with the aim of harmonising the methods of assessment related to the introduction of outpatient and hospital-only medicines. This originates from the reforms of pharmaceutical affairs, instigated by the Ministry of Social Affairs and Health in 2019.
Currently the early stages of an evaluation for outpatient medicines and hospital-only medicines are different and assessed by an application procedure (outpatients) or a model focused on initiatives by officials (hospital-only). In Fimea’s regular hospital-only drug assessment, it selects the assessment topics each month from among the CHMP’s positive opinions, sends an information request to the company in question and launches the assessment. In the pilot procedure however, the initiative will come from the company. The drug manufacturer informs Fimea of the new hospital-only medicine and the anticipated date for submitting the application, then proposes the scope of the assessment. Fimea will comment on the scope of the assessment and approve or reject the topic as an application procedure pilot. The company will then submit its final application at the time of CHMP’s positive opinion and the assessment will then be launched.
If the program is seen to be successful, it will be extended to a full application model, enabling the standardisation of elements such as application requirements and fees. This would eventually increase the coverage, predictability and speed of hospital-only drug evaluations.
Sources:
- (2023, March 01). Fimea initiates piloting of the application procedure in the evaluation of hospital medicines. Retrieved from https://www.fimea.fi/-/fimea-kaynnistaa-hakemusmenettelyn-pilotoinnin-sairaalalaakkeiden-arviointitoiminnassa
- (2023, February 21). Piloting the application procedure in the assessment of new hospital-only medicines. Retrieved from: https://www.fimea.fi/documents/542809/2233402/hakemuspilotit+210223_EN.pdf/3654e516-04eb-8a66-645d-892bb82dfa34?t=1677665689551