EMA tracks investment prices over time using weighted average. EMA gives more importance to recent price data than simple moving average. Multiple EMAs can be viewed together using moving average ribbons
PRAC issues PSUR recommendations for centrally and nationally authorised products. PSURs must be submitted according to EU reference dates (EURD list). Single PSUR required for products containing same active substance. EMA levies fee for PSUR assessment since August 2014
Biosimilars are highly similar biological medicines approved in EU since 2006. Biosimilars must demonstrate high similarity in structure, activity and safety. Minor differences between biosimilars and reference medicines are allowed. Biosimilars are approved according to same quality and safety standards as reference medicines
GCP is an international standard for human subject trials. Compliance ensures subject rights, safety and data credibility. Principles align with Declaration of Helsinki
EU requires all authorisation holders to operate pharmacovigilance systems. System operates through cooperation between Member States, EMA and Commission. Regional centres exist in some Member States under national coordination
All EU-market medicines manufacturers must comply with GMP. GMP ensures consistent quality and appropriate use of medicines. Manufacturers must register with national competent authorities