Arnold & Porter posted an advisory March 27th on Latest Guidance of the EMA and European and UK National Authorities on Crisis Management of Clinical Trials and Medicine Supplies During the COVID-19 Pandemic noting the recent EMA and MHRA guidances but also discusses the March 25th national Belgian Addendum to the EMA guidance:
On 25 March 2020, the Belgian Federal Agency for Medicines and Health Products (FAMHP) issued a national Belgian Addendum to the EMA guidance. Consistent with other national policies, the FAMHP gives priority to clinical trial applications for treatments of COVID-19 and applications for substantial amendments to the protocols of ongoing existing clinical trials during the COVID-19 pandemic.
FAMHP further clarifies the following points:
- Sponsors are not permitted to ship the investigational medicinal product directly to patients. The product may be shipped from clinical trial sites to patients under the direct responsibility of principal investigators without any involvement from sponsors.
- The safety and rights of the patients must be protected (e.g., confidentiality) and the investigational medicinal product must be suitable for transport, storage and administration at home.
- The process of home drug-administration must be documented, including the training provided to patients for the self-administration or the involvement of a healthcare professional for the administration at the patient’s home.
The FAMHP guidance also discusses the administrative steps for the notification of substantial amendments to the protocol and changes to the informed consent form related to the direct supply of the investigational product, but also temporary halts of the clinical trial, urgent safety measures and protocol deviations.
The FAMHP guidance also highlights that remote verification of data source is not permitted in Belgium as it violates the rights of the patients.