When innovation outpaces regulations: The legal challenges for direct-to-patient supply of investigational medicinal products.

ABSTRACT:

Aims

We profile the lack of specific regulation for direct-to-patient postal supply (DTP) of clinical trial medications (investigational medicinal products, IMPs) calling for increased efficiency of patient-centred multi-country remote clinical trials.

Methods

Questionnaires emailed to 28 European Economic Area (EEA) Medical Product Licensing Authorities (MPLAs) and Swissmedic MPLA were analysed in 2019/2020. The questionnaire asked whether DTP of IMPs was legal, followed by comparative legal analysis profiling relevant national civil and criminal liability provisions in 30 European jurisdictions (including The Netherlands), finally summarising accessible COVID-19-related guidance in searches of 30 official MPLA websites in January 2021.

Results

Twenty MPLAs responded

SUBMITTER: Malone M 

PROVIDER: S-EPMC9293225 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature