Earlier today the European Medicines Agency (EMA) announced that, from April 1, it will change how it handles variations to marketing authorisations – both minor and major changes – as well as periodic safety update reports (PSURs) and some other admin procedures.
The agency explained that: “The main change for applicants to these procedures will be a change in their EMA contact persons. Applicants will be informed directly by product and procedure if and when their contact person will change.”
The EMA announced its intention to restructure last January , explaining that the idea was to streamline its processes with the pharmaceutical industry in mind.
More detailed plans were unveiled in September when the agency explained it would change both how it reviews candidate drugs and how it assesses the manufacturing facilities in which they are produced.
At the time sxecutive director Guido Rasi said the changes will allow the agency to adapt to future challenges and seize opportunities, explaining that: “My aim is to give our scientific committees the best possible support, alongside the expertise from the national agencies, to help them keep delivering high-quality, consistent opinions.
“These changes will enable us to use our resources more efficiently and effectively and ensures that the Agency is better prepared for future legislative and policy challenges."
The restructuring process will continue for the rest of the year according to the EMA, with further modifications to how it reviews drugs being among the planned changes.
“The handling of all other evaluation procedures, including initial evaluation applications, will remain unchanged for the time being. Their roll-out is planned for later in the year.”
Few details of the upcoming changes were provided although the EMA confirmed that it plans to replace its current product team lead model with two new roles: a procedure manager; and an EMA product lead.
The procedure manager will “provide guidance on regulatory procedural matters and serve as the primary contact point for applicants and experts from the national competent authorities.”
The EMA product lead (EPL), in contrast, will monitor oversight of a drug throughout its lifecycle based on expertise in a specific therapeutic area.