Tag Archives: EMA

Module 6: Drug post-marketing follow up and pharmacovigilance

Introduction of drug post-marketing Usually, new drugs are approved based on the result of clinical research studies, also know as clinical trials, which involves relatively small number of patients selected for the purpose of assessing its safety and efficacy. Once these drugs are released on the market and prescribed to a higher number of people, a post-marketing follow up and […]

Read More

Module 4: The European regulatory framework and drug approval process

The EU regulatory system for medicines The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and the European Medicines Agency (EMA). This network is what makes the EU regulatory system unique. The network is supported by a […]

Read More