"Fortunately, innovative drugs have appeared in the world, which today have a direct effect against Covid-19. In order for us to be able to use them, for our citizens, we need a law, just as you and I passed a law last year that allows the emergency use of vaccines. We need to make the same changes today in order to treat people," said Mykhailo Radutsky, Chairman of the Verkhovna Rada Committee on Health of the Nation.
These drugs are still in the final stages of clinical trials but have already received permission for emergency use in medical practice in countries with strict regulatory systems. However, according to the current legislation, they cannot be registered in Ukraine today. Therefore, this document introduces a mechanism for simplified registration of drugs for emergency medical use for the prevention and treatment of coronavirus disease.
The Emergency Authorization (EUA) is a mechanism that facilitates the availability and use of medicines, vaccines or other medical immunobiological during emergencies and/or health quarantine.
According to the document, the possibility of emergency registration of such pills or other drugs is possible if:
- data on successful preclinical and clinical trials is available, such drugs must have an emergency use permit issued by a regulator of a country with a strict regulatory system (USA, UK, Swiss Confederation, Japan, Australia, Canada, Israel, EU countries), or a drug retrained for WHO emergency use;
- clinical trials were conducted with the permission and/or under the supervision (control) of the relevant competent authorities of the countries;
- the known and potential benefits of the medicinal product, when used for the diagnosis, prevention or treatment of identified serious or life-threatening diseases or conditions, outweigh the known and potential risks of the medicinal product;
- there is no adequate, approved and available alternative to a drug for the diagnosis, prevention or treatment of a disease or condition.
As it was reported earlier, the American pharmaceutical company Merck & Co together with Ridgeback Biotherapeutics announced the successful development of the first coronavirus pill, which halves the risk of death. The drug was named after the hammer of Thor, Mjölnir - Molnupiravir. According to the plan, the drug should become a “hammer from SARS-CoV-2” and new aggressive mutations.