Ministries seek drop in waiting times for med-tech clinical trials

Red tape involving clinical trials for new medical technologies is being cut by the Health and Finance Ministries, they announced on Thursday.

Shortening the time that regulators take to approve the trials on experimental drugs and medical equipment will advance Israeli medicine and encourage experimentation here rather than in various countries abroad.

The ministries stated that shortening the regulatory procedures on clinical trials here will “make it easier for researchers to get their work done, reduce costs for pharmaceutical companies and promote the competitive abilities of Israeli companies in the international landscape.”

The process of Health Ministry approval for launching clinical trials will take a maximum of 90 days instead of hundreds of days as in the past. Applicants will be able to apply for clinical trials directly through the Health Ministry and hospitals, instead of the current requirement of going through hospitals only.

The ministry also promised to improve its system of preparation and supervision throughout the whole procedure. It will also promote transparency of information and decisionmaking, and strengthen the network of expert advisers and the regulatory institutions, the ministries said.

The fast-tracking of the process and bringing it in coordination with standards abroad will increase the number and improve the functioning of young Israeli companies that carry out clinical trials here, the ministries said. In doing so, more international companies will be incentivized to set up research and development centers in Israel, and new medical technology jobs will be established.

The two ministries set up a joint steering committee that examined all the regulatory processes involved in clinical trials – including a look at what is done in advanced countries abroad – and identified what has caused delays.