When a therapeutic or vaccine candidate has completed the clinical trial process and data has been collected and analyzed, it may be submitted to relevant regulatory agencies for review. Before a medicine or vaccine can be made available for use on human beings, it must be approved by by the FAMHP, the Federal Agency for Medicines and Health Products.
A very small fraction of the candidates that begin evaluation will ultimately make it through the rigorous process of research, development, clinical testing and regulatory review to finally be approved as a medicine or vaccine.
Our R&D role continues well after a new medicine or vaccine is approved, where we conduct ongoing monitoring and evaluate the safety, effectiveness and value of our products.