Regulatory Authorities worldwide work more closely together because of COVID-19

Recommendation

15/16 November 2023

Serialization/Aggregation - Live Online Training
Requirements, Challenges & Solutions

The Swiss authority Swissmedic announced on its website that regulatory authorities around the world will work more closely together due to Covid-19. Three areas have been identified for this: research during pregnancy, medicinal products from clinical trials and monitoring of vaccines in terms of safety and efficacy.

For the second time, representatives from more than 25 countries, representing 28 drug regulatory authorities and the WHO, came together. Observational research is to be intensified by exchanging information on experiences from the development of treatments and vaccines against COVID-19. Data from observations or from clinical practice in the real world are an important complement to the information obtained from clinical trials. The current workshop identified three areas where cooperation between health authorities should be improved:

• Pregnancy research on the impact of COVID-19 as well as medicines on pregnant women and their unborn babies
• Establishment of clinical cohorts of COVID-19 patients (special observational clinical studies) to share expertise and improve the quality of clinical trial data
• Preparation of an infrastructure to monitor the safety and efficacy of vaccines being developed against COVID-19

The improved cooperation should not only help during COVID-19, but also strengthen future observational research by the countries.

Here you can find the report of Swissmedic.