EMA releases joint strategy for regulatory agencies to 2025
The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have published their joint strategy for the next five … read more »
EMA to host workshop on regulatory support for development of orphan medicines
The European Medicines Agency (EMA) is hosting a workshop on 30 November to discuss the benefits and impact of early … read more »
EMA organises public meeting on COVID-19 vaccines
The European Medicines Agency (EMA) has organised a public meeting on 11 December 2020 to inform European citizens about the … read more »
EMA releases guidance for COVID-19 vaccine approval
The European Medicines Agency (EMA) has released guidance for developers of vaccines against COVID-19 on the clinical evidence that must … read more »
EMA holds symposium on patient-focussed cancer drug development
The EMA held a symposium on 29 October to discuss the potential use of input from cancer patients in informing … read more »
IFPMA and EFPIA back EMA’s initiative to increase transparency in the regulatory process
The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) have released … read more »
EMA’s IRIS system for scientific advice opens on 19th October
As previously reported by MAP, the European Medicines Agency (EMA)’s Regulatory & Scientific Information Management Platform IRIS should be used … read more »
EMA begins second rolling review of a COVID-19 vaccine
The European Medicines Agency (EMA) has begun a ‘rolling review’ of data on a vaccine for COVID-19, which is being … read more »
EMA reaffirms commitment to independence and transparency for COVID-19 treatments and medicines
The European Medicines Agency (EMA) has explained, in an open letter that it will consider products for the current pandemic … read more »
EMA’s IRIS system to be opened to all scientific advice applications
The European Medicines Agency (EMA) Regulatory & Scientific Information Management Platform IRIS will be the compulsory submission method for scientific … read more »