Dealing with authorities on regulatory issues to be made easier.

The Federal Institute for Drugs and Medical Devices (BfArM) wants to encourage promising new medicinal products and medical devices by offering early consultation and support to start-ups and small research organisations. The aim is to avoid start-up projects failing due to a lack of experience in dealing with authorities.  

On 25 January 2017, the BfArm and the Federal Ministry of Health (BMG) announced the launch of the Innovation Office. “The Innovation Office will be an uncomplicated first port of call for start-ups, researchers and developers who need advice about the formal requirements of the healthcare market,” said Lutz Stroppe, Permanent State Secretary at the Federal Ministry of Health.  

In an innovative environment that is strongly European and International, the service is also aimed at foreigners. As such, the BfArM provides its consulting services in German and English.  

The Innovation Office will provide regulatory assistance and thus help avoid wrong decisions being made in the early development phase of new products. An example for medical devices is to advise developers of medical apps, at a very early stage, that these can possibly be categorised as medical devices and provide them with information about the relevant regulatory consequences. From the point of view of the German Social Insurance, the classification of relevant apps as medical devices is important for their safety and reliability. Providing advice early on means that more medical apps will be able to go through the conformity assessment procedure as required by European legislation on medical devices.  

The Innovation Office can also help in the area of medicinal products by drawing attention at an early stage to which data is needed or which specific requirements must be met for certain product groups, for example, quality requirements.  

The initiative is aimed, among other things, at ensuring that medical apps and new medicinal products bring real benefits to patients and are available sooner. Access to new medicinal products and technologies, and assessment of them, is also being discussed intensively at EU level. The National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) and other health insurance organisations in Europe have recently expressed their support for strengthening European cooperation on Health Technology Assessment. (For more, see Health Technology Assessment: Strengthening voluntary cooperation). 

The EU plays an important role, alongside the Member States, in discussions about health apps. This involves testing the safety and market access of digital products as well as reimbursement by health insurance. The German Social Insurance and the European Social Insurance Platform (ESIP) have already put forward their views during various consultations and working groups of the European Commission. (For more, see Digital health at EU level). 

More information can be found on the BfArm website: 

http://www.bfarm.de/EN/BfArM/Org/Advice_Procedures/_node.html