EMA starts efficiency improvement programme
Will assess processes for authorisation, supervision and maintenance of medicinal products
The European Medicines Agency (EMA) has launched a root-and-branch assessment of its core pharmaceutical assessment work to improve its efficiency.
EMA said it would ‘ensure a continuous high-quality delivery of [its] core business in an increasingly complex regulatory and scientific environment, while making optimal use of available resources’. It will initially assess its processes for the authorisation, supervision and maintenance of medicinal products. The agency noted that ‘improvements will result from identification and elimination of internal process complexity’.
EMA will also try to work with pharmaceutical companies to help them improve their applications, saying that ‘significant improvements in throughput and lead time will require that applications be submitted to the highest possible standard’.
The agency said it would provide a pre-notification checklist to help applicants submit variation-of-use notifications for medicines ‘with the aim of raising the quality of these applications’. Notifications are ‘often not correct or incomplete, despite post-authorisation guidance,’ EMA said.