Identification of regulatory needs for nanomedicines 1st EU-NCL survey with the 'Nanomedicine' working group of the international pharmaceutical regulators

The application of nanotechnology in healthcare is widely accepted as a potential driver of biomedical innovation. By exploiting the unique physical and physicochemical interactions at the molecular level nanotechnology based products (also known as nanomedicines) can monitor, repair and control biological systems in order to address diseases for which currently no or only insufficient diagnostic and therapeutic tools are available. Nanotechnology will also play an enabling role in the implementation of personalised medicine as it provides tools for a better prediction and early diagnosis, the design of personalised treatment as well as a close monitoring of the therapeutic success. However, the opportunities of nanotechnologies in the health sector are coming along with challenges in the regulation of this emerging product class. Sufficient knowledge on their quality, safety and efficacy must be gained and standardised methods must be made available to support the regulatory decision making and allow a smooth translation towards clinical applications. The current survey was performed within the "nanomedicine" working group of the International Pharmaceutical Regulators Forum (IPRF) with the aim to get a general overview on the status and regulatory needs of nanomedicines. The survey demonstrated strong regional differences in the regulation of nanomedicines and demonstrated that in the last years, the European authorities have received fewer applications of nanotechnology based pharmaceuticals as e.g. the USA. However, a future increase of market applications must be anticipated in Europe as other regions which have a better ecosystem for the marketing of nanomedicines are already facing challenges in the regulation of nanotech products. These expectations are supported by the fact that the last EC's framework programmes have invested hundreds of millions of Euro into nanomedicine development in order to make these promising products available to the patient. An intensive exchange of experience in the regulation of nanodrugs between regulatory bodies is now necessary to ensure harmonised regulation of products internationally. The respondents of the survey confirmed the need for the harmonisation of information requirements on nanospecific properties. A number of critical physicochemical properties have already been proposed in the scientific literature and their relevance for regulatory decisions was verified within the survey. Some regulatory agencies also indicated the need for additional (eco)toxicological testing triggered by the nanospecific property of the product. Finally, there was consensus among the regulatory agencies for a need of an independent nanocharacterisation testing facility that can support regulators in the evaluation of sophisticated material and the performance of new test methods before entering into clinical applications.
JRC.F.2-Consumer Products Safety