After the development phase, a registration file
containing the detailed results of all the research
conducted on the compound and its formulation
is submitted to local or regional health regulatory
authorities in charge of assessing the efficacy
and safety of the drugs. If analysis proves that the
benefits outweigh the risks for a specific disease
pattern, and if all regulatory requirements are
fulfilled, the regulatory body authorizes the drug
to be marketed.
The price of the drug is then either set by health authorities or independent committees based on diverse methods that vary according to countries and healthcare systems, such as the cost-effectiveness ratio, reference pricing (in countries where the prices of drugs are regulated), or set directly by the pharmaceutical company.
Examples of Sanofi's good practices
Coordinate pricing policies with health authorities,
reimbursement bodies and NGOs to make existing
drugs affordable for patients.
Develop and market specific healthcare products
and services for lower-income patients.