The European Medicines Agency (EMA) is an agency of the European Union (EU) that evaluates and regulates pharmaceutical goods. Prior to 2004, it was called the European Agency for the Evaluation of Medicinal Products (EMEA).The primary goal of the European Pharmaceuticals Agency (EMA) is to preserve and promote human and animal health by analyzing and monitoring pharmaceuticals across the European Union (EU) and the European Economic Area.
Founded in 1995, the European Medicines Agency (EMA) has worked across the European Union (EU) and globally to protect public and animal health by assessing medicines to rigorous scientific standards and by providing partners and stakeholders with independent, science-based information on medicines. EMA has a 25-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. EMA's success is based on cooperation within the European medicines regulatory network. Working together has encouraged the exchange of knowledge, ideas and best practices, in order to ensure the highest standards in medicines regulation.
Quality guidelines are provided for:
Active substance
Manufacturing
Impurities
Specifications, analytical procedures and analytical validation
Excipients
Packaging
Stability
Pharmaceutical development
Quality by Design
Specific type of products
Lifecycle management
Regulatory Approval :
European Medicines Agency (EMA) was established by EU Regulation 2309/93, where the goal of the EMA was to coordinate the evaluation of scientific data associated with the approval, manufacturing, and inspection of medicines in the EU (24). This EU Regulation is dated Jul. 22, 1993.
EU Regulation 2309/93 is divided into 74 pieces, known as Articles 1–74."To lay down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and to establish a European Agency for the Evaluation of Medicinal Products," according to the regulation's first article. On the basis of Article 3, "No medicinal product referred to in Part A of the Annex may be placed on the market within the Community unless the Community has granted a marketing authorization in compliance with this Regulation's provisions."