Ukraine extends fast track procedures to COVID-19 vaccines, biologics authorisation, clinical trials

In December 2020, the Ukrainian parliament amended emergency legislation passed in response to the pandemic to include fast-track procedures for vaccines and biologics for specific prophylactics of COVID-19.

Passed in March 2020, the original emergency law allowed COVID-19 positive patients:

• To be treated with medicines not yet authorised in Ukraine; and
• Broad "off-label" use of authorised medicines.

The original law permitted this usage only for the treatment of COVID-19 and only for medicines recommended by US FDA, competent authorities of any of the EU member states, UK, Switzerland, Japan, Australia, Canada, China or Israel.

The March 2020 law also introduced emergency fast-track procedures for:

• approval of clinical trial protocols (or substantial amendments to these protocols) for medicines with the potential for COVID-19 treatment;
• authorisation for medicines for the treatment of COVID-19.

These emergency procedures did not attempt to supersede the authority of Ukrainian regulatory bodies, but sought to expedite their assessment and decision-making processes for the approval of treatments/clinical trial protocols (reducing the process to between seven and ten days).

Because the fast track procedures were only applicable to therapies for treatment and not for COVID-19 prophylactics, the December 2020 amendments were passed, which enable the launch of COVID-19 vaccines and biologics clinical trials in Ukraine and could ensure rapid access to such products following authorisation.

For more information on these amendments and regulations governing COVID-19 therapies in Ukraine, contact your regular CMS client partner or local CMS expert: Borys Danevych.