An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.
SIMULTANEOUS NATIONAL ADVICE PILOT ALSO SUPPORTS INNOVATION Source: Shutterstock
Drug companies operating in the EU will soon have another option when it comes to seeking scientific and regulatory advice thanks to a pilot scheme that is being launched on 1 February. They will be able to request simultaneous advice from any two of the 12 EU national competent authorities (NCAs) participating in the pilot.
The new pilot is designed to optimize resources for both companies and regulators, and improve regulatory support, Belgium’s Federal Agency for Medicines and Health Products said in a guideline giving details about the simultaneous national scientific advice (SNSA) project.
At present, companies can apply for national-level scientific advice by approaching the NCA in each member state individually, or they can obtain advice at a central level from the European Medicines Agency. While advice at the central level is consolidated, companies usually first apply for national-level advice to prospectively optimize their development programs.
Experience has shown that national advice is often requested from more than one NCA, the guideline notes. Under the pilot, companies will be able to request national scientific and/or regulatory advice simultaneously from two NCAs through a single application for the same set of questions and data package.
The 12 NCAs currently participating in the pilot are from: Spain (AEMPS), Austria (AGES), Italy (AIFA), Germany (BfArM and PEI), Belgium (FAMHP), Finland (FIMEA), the UK (MHRA), Norway (NOMA), Hungary (OGYEI), Czech Republic (SUKL) and Poland (URPL).
Identifying And Avoiding Gaps
The pilot was drawn up by the EU-Innovation Network (EU-IN), which comprises national-level innovation offices set up by EU member states along with the EMA’s Innovation Task Force. It is expected to help identify and avoid gaps in the provision of early regulatory support for innovative products under development and to identify sponsors’ needs. (Also see "Simultaneous Early Scientific Dialogue On The Cards In Europe For Innovators" - Pink Sheet, 19 Jul, 2019.)
The pilot is expected to help companies by enabling earlier:
> Exchange of opinions and interaction with experts from NCAs, compared with the current process of approaching NCAs sequentially.
> Identification of possible divergent opinions by NCAs and also the potential for alignment before an application is submitted (eg for clinical trials, marketing authorizations or variations/line extensions). Under the pilot, the NCAs would aim to provide consolidated views to the maximum extent possible although complete harmonization is not the main objective of the scheme.
> Identification of critical scientific or regulatory issues that may require centralized scientific advice from the EMA.
The pilot is open to more NCAs for participation. The aim is to get as many NCAs as possible involved to create the highest possible amount of NCA pairs for the pilot, the Belgium agency explained in its guidance. Information on all participating NCAs will be available on the websites of the EMA and the EU Heads of Medicines Agencies when the pilot is formally launched.
The pilot will run until the end of 2020. If it shows there is sufficient demand for simultaneous scientific advice and the concept provides added value to both companies and regulators, it will be optimized further and may be extended in a next project phase with more than two NCAs participating in the advice process, the Belgian agency said.
The new approach is expected to be a complementary tool to the existing scientific/regulatory advice procedures available at national and the EU level.
During the pilot, a company will be able to request simultaneous advice by submitting a letter of intent to one of the two NCAs of its choice. Alternatively they can submit an existing application form for national scientific/regulatory advice to the NCA.
The scope of advice that can be sought is identical to the type of advice currently offered by NCAs at national level, such as questions relating to the quality, safety and efficacy of medicines, clinical trial applications/concepts (eg, study design and statistical aspects), but excluding health technology assessment and reimbursement aspects.
Companies can also seek advice on drug/medical device combination products if these type of products falls within the remit of the participating NCAs.
There are no restrictions on the type of sponsors that can apply for simultaneous national advice. Special guidance will be provided for academia and small- and medium-sized enterprises, especially regarding requests for early advice in the innovation process.
While the pilot is expected to benefit companies and NCAs in terms of saving time and resources, it also has the potential to support innovation by providing a practical tool to help identify the challenges in the development of innovative technologies.
Among other things, it makes it possible for the EU medicines network to share knowledge and lessons learnt from completed SNSA procedures and thereby improve preparedness for upcoming innovation. In addition, it provides an opportunity to discuss divergent opinions and creates awareness for possible steps towards gradual convergence of identified issues, especially in the context of innovative products and therapeutic concepts.