Search results with tag "Medicines agency"
ANNUAL REPORT 2020 - European Medicines Agency
www.ema.europa.euMedicines Agency (EMA): • provides independent, science-based recommendations on the quality, safety and efficacy of medicines, and on more general issues relevant to public and animal health that involve medicines; • applies efficient and transparent evaluation procedures to help bring new medicines to the market by means of a single, EU-wide
Guidance to applicants (Q&A) - European Medicines Agency
www.ema.europa.euEuropean Medicines Agency Guidance for applicants seeking access to PRIME scheme EMA/191104/2015 Page 5/10 PRIME is not the right support tool for you if: You are already in the MAA pre-submission phase (i.e. you have submitted a letter of intent for a MAA). In this case, you should consider alternative tools (e.g. pre-submission meeting request,
Assessment report - European Medicines Agency
www.ema.europa.euIn November 2012, the European Medicines Agency ’s Committee for Medicinal Products for Human Use (CHMP) recommended the authorisation of aflibercept (Zaltrap) in combination with
Monitoring of medical literature and the entry of relevant ...
www.ema.europa.euMonitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency EMA/517840/2015