Masterarbeit
Approval options of therapeutics for treatment of the Coronavirus disease 2019 and their current regulatory environment ***
Dr. Daniel Sohmen (2022)
Summary
Language: English
The occurrence of the severe acute respiratory syndrome Coronavirus type 2 (SARS-CoV-2), responsible for the Coronavirus disease 2019 (COVID-19) lead to the third and largest pandemics in the twenty-first century. At the beginning of 2022, already more than 5.6 million people died due to COVID-19. An end of the health crisis is not yet in sight even though multiple vaccines are already available. New mutated variants of the virus like the currently rife omicron virus variant are showing greater transmissibility and immuno-evasion capabilities as the initially discovered alpha variant of the virus and are threatening to foil the success of the latest drug developments. Poor vaccine acceptance within the population and a low vaccine availability worldwide thus makes the development of further therapeutics, diagnostic tools and preventive measures to treat patients and to fight the symptoms of COVID-19 necessary. Around the globe, hundreds of development programs are underway to identify promising new drug candidates and to prove the drug products safety and efficacy against COVID-19. This creates an as of to date unprecedented amount of stress on regulatory bodies and regulators around the world whose goal it is to bring safe and effective medicines to patients everywhere as fast as possible. Multiple health crisis emergency protocols are currently in place and health authorities and developers are making use of expedited approval pathways and emergency procedures to shorten the timelines for granting marketing authorizations of drug products as fast as possible without compromising the robustness of scientific data to ensure the safety and efficacy of newly developed drugs to fight this pandemic. The challenges, possibilities, and new regulatory developments to approve safe and efficient therapeutics in the European Union and the United States of America to treat COVID-19 shall be discussed in this thesis.
Seiten/Pages: 53