What are the pros and cons of drug registration process in Europe? Please answer at your own easy words. Answer should be to the point. I will rate you positive if you do so.
The drug registration process in Europe refers to the procedure by which pharmaceutical companies obtain authorization to market and distribute their drugs within European Union (EU) member states.
There are two main routes to authorize medicines in Europe - the centralised route and national route. The centralised route involves submitting one marketing authorization application to the European Medicines Agency (EMA). This single application allows marketing of the medicine throughout the European Union (EU) and European Economic Area (EEA) based on a unified authorization.
The national route requires submitting applications to the competent national authorities of EU member states. Applications can be submitted individually or via mutual recognition/decentralized procedures.
It provides advantages like marketing a drug across multiple countries with one application. However, it also presents challenges companies must consider. Some challenges are navigating different regulatory bodies and fulfilling all their requirements.
Step by step
Solved in 4 steps
