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 »
EMA consults on registries
The European Medicines Agency (EMA) has released a paper of consultation entitled Guideline on registry-based studies. EMA said: “The EMA … read more »
Analysis proves EU safety system robust
The European Medicines Agency (EMA) has produced a report into its incident management plan (EU-IMP) showing it has functioned effectively … read more »
EMA gears up to gather RWE on COVID-19 treatments and vaccines
The European Medicines Agency (EMA) has launched the required infrastructure required to carry-out real-world monitoring of the products used in … read more »
EMA and HMA launch consultation on joint network strategy
The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have launched a consultation into their joint network strategy … read more »
EMA and FDA strengthen collaboration on medicines
The European Commission (EC), European Medicines Agency (EMA) and US Food and Drugs Administration (FDA) have agreed new priorities in … read more »
