It takes decades of painstaking work to create a new drug, which requires significant investments by the company. The first stage is connected with the development of the active substance molecule – the basis of the future medicine.
The second stage is one of the most expensive and time–consuming – it is a safety and efficacy check, the study of side effects, compatibility with other drugs, the collection of dossiers for each dosage and other special studies.
After that, the medicine undergoes a long and complicated registration procedure.
For example, HOFITOL ® – a drug for improving the flow of bile and protecting the liver based on artichoke leaf extract 1 – was the first to be registered and placed on the world pharmaceutical market based on a dossier that presented the results of complete preclinical and clinical studies confirming its quality, safety and efficacy.
This means that HOFITOL ® has the status of an originator drug, that is, the first registered drug with this active ingredient.