"The industry wants greater clarity among regulators, more uniform standards, and more harmonization," Beat Loeffler, chief executive of the European Foundation for Clinical Nanomedicine (CLINAM), Basel, Switzerland, told BioPharm International. "There is a feeling that the regulators do not know what they want." An annual international conference on clinical nanomedicines, organized jointly at Basel in June 2013 by CLINAM and the European Technology Platform on Nanomedicine (ETPN), called for greater consistency among regulators in dealing with new nanopharmaceutical products.
In an earlier recommendation, made in October 2011, the EC provided leeway for national governments to apply their own controls on nanomaterials by recommending a broad definition of "nanomaterial." A material was defined as "nano" when it contained 50% or more particles in the size range of 1–100 nm. The EC also acknowledged that because of "special circumstances" in the pharmaceutical sector, the recommendation of an upper limit of 100 nm should "not prejudice the use of the term nano when defining certain pharmaceuticals and medical devices."
France has been among the most ambitious EU member states in introducing a new nanotechnology legislation, which came into effect in May this year, but which has, so far, not raised any significant opposition among French pharmaceutical companies. Its main requirement is that manufacturers, importers, and distributors of engineered nanosubstances make annual declarations to the French government of the amounts they are placing on the national market with details of their uses.
"This legislation is not a hurdle and the provision for annual declaration encourages transparency, which is a desirable objective," explains Laurent Levy, chief executive of Nanobiotix, Paris, a nanomedicine company and a member of the biotechnology committee of the French Pharmaceutical Companies Association. The increase in new nanomaterial legislation at the national level in Europe is, however, causing some nanomedicine companies to see regulation as being an obstacle to innovation.
"Small and medium enterprises (SMEs), in particular, are regarding regulation in nanotechnology as a barrier," Levy, who is also vice-chairman of the ETPN, an EU-funded research organization, said in an interview with BioPharm International. "But once they start interacting with the regulatory authorities about their new products, they become much less concerned because they are in a dialogue with the authorities during the development of their nanoproducts, and therefore, will know what is expected of them."
Nanobiotix has been keeping in close contact with the French National Agency for the Safety of Medicines and Healthcare Products (ANMS) in the development of a nanoparticle-enhanced radiotherapy technology. In June 2013, ANMS authorized the company to start a clinical trial of the technology for the treatment of head and neck cancer.
The Nanobiotix technology, however, is an example of disparities outside Europe in the international classification of nanomedicines. In Europe, it has been categorized as a medical device, while in the US, FDA considers it to be a drug. As a result, Nanobiotix reckons its first products will reach the market more quickly in Europe than in the US because European national authorities responsible for licensing medical devices require fewer clinical trials than with pharmaceuticals.
"There may be a bit of a difference in the time to market between Europe and the US, but in the end, you have to meet the same regulatory requirements of demonstrating an acceptable benefit-to-risk ratio," explained Levy.