EMA Sees Increase in Early Dialogue with Biosimilar, New Drug Developers

Regulatory NewsRegulatory News | 06 October 2015 |  By 

The European Medicines Agency (EMA) is seeing a sharp rise in demand from drug developers seeking dialogue earlier in the drug development process, particularly for biosimilars and drugs with a new active substance, EMA's management board said Tuesday in an update on the first half of 2015.

Of the marketing authorization applications for drug products containing a new active substance and for biosimilars that were submitted in the first half of 2015, 77% had received scientific advice.

"This demonstrates that EMA’s efforts to encourage medicines developers to seek interaction and dialogue with the agency are paying off," EMA said.

In addition, the number of requests for scientific advice and protocol assistance rose by 6% compared to the same period last year. Among those requests, the number of requests for parallel scientific advice with health technology assessment (HTA) bodies more than tripled, from six in the first half of 2014 to 21 in the first half of 2015.

The parallel procedure enables drug developers to obtain feedback from regulators and HTA bodies at the same time and early in the drug development process.

Interactions with Industry Associations

In addition to EMA's interactions with individual companies, the board also adopted a framework that formalizes and structures how the agency will interact with industry associations. The aim of the framework is also to enhance the understanding of the European Union (EU) medicines regulatory framework and increase transparency of EMA’s engagement with industry and report on these interactions annually.

The framework covers a broad range of industry association types, including industry trade associations, organizations engaged early on in the innovation lifecycle, associations of service providers or professionals supporting the industry and associations with multi-stakeholder membership including industry. 

Clinical Trial Portal and Database

The EMA Board also endorsed the addendum to the functional specifications of the EU portal and database, which are part of the transparency rules of the European Clinical Trial Regulation.

And as far as the timeline for the implementation of the clinical trial portal and database, the board said the plan is to have the system available for an independent audit by the end of the third quarter of 2016. If the portal and database get the go-ahead from the audit, the regulation will come into application by the end of 2017.

EMA Management Board Highlights of October 2015 meeting


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy