Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Coronavirus Pandemic (COVID -19) - Influence on Pharma Industry and Competent Regulatory Authorities and corresponding strategies/actions to deal with the situation

Dr. Katrin Bäsell (Abschlußjahr: 2021)

Summary
Language: English
The severe acute respiratory syndrome coronavirus type 2 (SARS CoV-2), the causative agent of COVID-19 disease, changes the world. The novel virus spread from China throughout the world. The number of infected people as well as the number of deaths is increasing rapidly and health care systems are strongly being stressed by the high number of intensive care patients. The governments responded accordingly with protective and isolation measures such as border closings, exit bans and lockdowns.  All these measures have a significant impact on public life, supplies and the economy, including the pharmaceutical industry. How pharmaceutical companies and regulatory authorities are impacted and what countermeasures can be taken is compiled and discussed in this thesis.  An anonymous questionnaire was performed and analysed to get an impression of the extent to which European pharmaceutical companies have been affected by the COVID-19 pandemic so far and which measures have been taken. Furthermore, the regulatory flexibility/support regarding the development/registration of COVID-19 treatments and vaccines was presented and evaluated by means of examples.
In summary, the pharmaceutical company's workforce, regulatory processes to be conducted, production, distribution and stock level can be negatively impacted by COVID-19 and may lead to supply shortages that may have a direct impact on public health. Various countermeasures can be chosen by companies, including the introduction of home office /mobile working and flexible working time to reduce the risk of infection and to protect the employee and therefore to maintain the working ability and which the companies surveyed have successfully established. To prevent drug shortages, the company can increase the production or re-arrange the supply chain, for example. The latter is also supported by an increased flexibility in regulatory processes offered by the authorities, including the “Exceptional change management process“ (ECMP) for example. As this process is limited in applicability, a proposal is made on how the process could be adapted to expands the application range, but without endangering the quality and safety of the product. Further offered fast-track procedures or exception applications in terms of facilitating regulatory processes were described and discussed. The companies surveyed applied for different processes and have experienced varying outcomes. In total the offered regulatory flexibility was only used by a limited number of companies surveyed. The possible reasons for this are discussed.
In the event of a pandemic, the time factor plays a major role. The longer no effective therapy and treatment is available, the greater the negative impact on the public health. Therefore, a particular focus of the EU, the Member States and authorities is to support the development and authorisation of COVID-19 treatments and vaccines. Several fast-track procedures have been published on EU level and recommendations and facilitations were given, which are compiled in this thesis. These options have already been used from companies in case of COVID-19 treatment and vaccines. In comparison to the timelines of the standard processes, it could be shown by means of examples that the regulatory flexibility offered was successfully used and that the processing timelines were significantly shortened. The offered regulatory flexibility is therefore very supportive for a rapid authorization of urgently needed COVID-19 vaccines and treatments.
Pages: 74 (including figures, table and references)
Annex: 1, Pages: 7