Clinical Studies Regulations – Update
The Israeli Ministry of Health (the “MOH”) issued, on March and April 12, 2020, certain guidelines for the performance of clinical studies during the COVID-19 pandemic (See also our previous updates from March 2020 and April 2020).
On June 1, 2021, the MOH cancelled the specific Covid-related guidelines for the performance of clinical studies. However, several of these guidelines remain in effect for a pilot period until the end of 2021. The following are the main provisions that apply during the pilot period:
- Remote measurement of medical parameters, treatment at the patient’s home and delivery of investigational product to the patient’s home will be done as needed and will be subject to the approval of the applicable institutional Helsinki Committee (also referred to as ethics committee/IRB). Sponsors of studies are required to establish internal standard operating procedures (SOP) in order to prevent a mix up in delivery of the investigational product to patients’ homes.
- The supply of the investigational product (in compliance with GCP standards) will the responsibility of the principal investigator (or a person authorized for that matter), in coordination with the medical institution’s responsible pharmacist.
- Each institutional Helsinki Committee will decide how applications for new studies should be submitted for review (either by electronic means or as a hard copy).
- Informed consents may be obtained by electronic means (subject to the MOH’s procedures).
- Administrative and logistical changes to a study’s documents will be sent to the institutional Helsinki Committee as a notification only (unless otherwise instructed by the relevant Helsinki Committee).
- Information required to be submitted to the Clinical Studies Department at the MOH will be submitted both digitally and as a hard copy (via a disk on key).
All other aspects relating to the performance of clinical studies shall continue to be regulated by the MOH’s Procedure No. 14, titled “Procedure for Medical Studies in Humans”, as amended at the end of 2019, and entered into effect on January 1, 2021.
We note that the above is merely a short summary of the subject matter, and does not cover all relevant provisions of the guidelines.
For additional information please contact your GKH attorney or one of the following Adv. Hili Cohen, partner and head of life sciences department (Hili@gkh-law.com), Adv. Tami Fishman, partner (Tamif@gkh-law.com), or Adv. Ofir Goldstein (Ofirg@gkh-law.com).
