From March 1, the European Medicines Agency (EMA) will start to publish information on applications for centralised marketing authorisation (MA) which it has received for evaluation.
The EMA will publish the generic name and therapeutic areas for all new innovative medicines being evaluated by the Committee for Medicinal Products for Human Use (CHMP), along with information on the type of salt, ester or derivative of the active substance. For generics and biosimilar drugs, it will publish the generic name and therapeutic area.
The Agency says it will publish this information only for medicines whose applications have been validated, and will update it every month following the plenary meeting of the CHMP.
This initiative forms part of the drive towards increased transparency on EMA activities by the Agency and other European regulatory authorities, and expands on its current publication of information on designated orphan medicines being assessed for MAs in the monthly reports of the Committee for Orphan Medicinal Products (COMP), it says. The Agency points out that, currently, it does not publish information on other types of medicines until it has issued an opinion at the end of the assessment procedure.
The EMA has also reminded applicants and holders of MAs that, as is the case every year, adjusted fees will come into effect on April 1. The European Commission is currently in the process of adopting a regulation adjusting the fees payable to the Agency in line with the 2011 inflation rate and, although the final adjustment is not yet known, the Agency says it expects its fees to increase by around 3.1%
Full details of the revised fees will be published at the end of March, once the Commission has adopted the regulation and published it in the Official Journal of the European Union (EU), and when the EMA Management Board has reached a decision on implementation of the regulation, says the Agency.
It also points out that all applications which it receives by March 31 will be charged at the current fee and reduction rates, while those received after that date will be charged the adjusted fees and be subject to the revised reduction rates, where applicable. For scientific advice and protocol assistance for human-use medicines, the cut-off point will be the date of validation of the request for advice.
Finally, the EMA's newly-published work programme for 2012 reports that activities this year will focus on implementation of the pharmacovigilance legislation and also on preparations for the new legislation on falsified medicines, the majority of which will come into force in January 2013.
Also during the year, work will continue to define what information is considered commercially confidential and how to best comply with protection of personal data, says the Agency's executive director, Guido Rasi.
"Agreement on these issues will pave the way for further measures that will allow the Agency to move from reactive to proactive publication of various documents," he says, adding: "the Agency and its network partners believe that the latter would save resources in the long term."
The EMA will also finalise its transparency policy this year, following the outcome of a public consultation, and, in the meantime, the most notable deliverables in the area of transparency in 2012 will be granting access to EudraVigilance data for human and veterinary medicines, providing more information on clinical trials and starting the publication of scientific committee agendas and minutes.
"Access to documents will remain an area that consumes significant resources," notes Prof Rasi. "The Agency will further develop processes and systems to make information of interest to the public available quicker and in a more efficient manner. The Agency's website will be adapted to include a single point of entry for all requests for documents or information," he says.
The Agency also says it expects to receive a “stable” number of MA applications for both human-use and veterinary medicines during the year.
