What Is Clinical Trial EMA? The European Medicines Agency (EMA) relies on the results of clinical trials carried out by pharmaceutical companies to reach its opinions on the authorisation of medicines. … It also manages a database of clinical trials carried out in the European Union (EU). What is EMA process? Under the centralised authorisation
What Is European Equivalent Of FDA? European Medicines Agency (EMA) : The European Medicines Agency (EMA) is a decentralised body of the European Union, located in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. What is FDA
What Is Decentralized Procedure? The procedure for authorising medicines in more than one European Union Member State in parallel. It can be used for medicines that do not need to be authorised via the centralised procedure and have not already been authorised in any Member State. What is centralized procedure in EU? Marketing authorisations granted
What Is The FDA Drug Approval Process? Phase I: Discovery & Development. Phase II: Preclinical Research. Phase III: Clinical Research. Phase IV: FDA Review. Phase V: FDA Post-Market Safety Monitoring. How long does FDA Drug Approval take? Priority Review: During Priority Review, the FDA takes action on a new drug application within six months, compared
What Is NDA In FDA Approval? The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug Why NDA is submitted to FDA? The