EMA Highlights: Drug developers get regulator advice on new meds
by Gary Finnegan: Most successful applicants to the EU drug watchdog, the European Medicines Agency, have something in common: they seek scientific advice from the regulator when developing their product.
Approximately 85% of companies developing medicines containing new active substances first applied for input from the EMA to ensure they collected the right data on the benefits and risks of their product.
Combined figures for new and existing products, published with the EMA 2015 annual report, show that one in two applicants receiving positive opinions from the Agency had availed of its scientific advice. This includes applications for extended licenses and new indications.
The regulator is actively encouraging drug developers to engage with its expert services as early as possible and offers reduces fees to small and medium enterprises (SMEs) as well as incentives for the development of medicines for rare diseases.
The annual report shows that 93 marketing authorisations were given for human medicines last year, including 39 new active substances. Fourteen veterinary medicines were approved, half of which were based on new substances.
It was also a busy year for the EudraVigilance database which records adverse drug reactions. Over 48,000 reports from patients in the European Economic Area were made – up 30% on the previous year. The Agency says this shows patients are making increasing use of the opportunity to directly report side effects they experience.
In 2015, the product information on many medicines was updated as new safety information had become available. The revised information will allow patients, healthcare professionals and veterinarians to make informed decisions based on the latest evidence when using or prescribing the medicine.
EMA’s annual report also highlights some of the main projects, initiatives and achievements in 2015 that have had a significant impact on the Agency and the way it operates. Among these are: the preparation for the launch of PRIME (PRIority MEdicines) to support the development of medicines that address unmet medical needs; initiatives to help fight antimicrobial resistance and other public health threats such as Ebola as well as the implementation of various new pieces of legislation including a range of new activities to further strengthen the safety monitoring of medicines.