11/12 October 2022
Nanotechnologies gain more and more importance in the manufacture of biopharmaceuticals. How to manufacture, characterise, and control the drug-release mechanism for such next generation of nanomedicines as well as the assessments of possible effects for human and environment are the focus of sciences, industry and authorities. This is also reflected in the increasing publication of relating regulatory documents. The FDA has already published a number of documents on the topic of nanotechnology in "FDA Issues Three Final Guidances Related to Nanotechnology Applications in Regulated Products, Including Cosmetics and Food Substances".
In December 2017, the FDA published another document, a draft guideline with the topic "Drug Products, Including Biological Products, that Contain Nanomaterials".
The FDA thereby acknowledges the fact that many FDA regulated products may contain nanotechnologies, be it as an active substance, a carrier or vector for active substances or as a non-active component. The use of such nanotechnologies may lead to considerable variations from conventional biopharmaceuticals and therefore requires special monitoring and assessment. The present draft is to pose as a guideline for the development of products containing nanomaterials in their final application form. It focusses on the considerations of the relevant FDA regulations for such drug products according to the Federal Food, Drug, & Cosmetic Act (FD&C Act) and the Public 50 Health Service Act (PHS Act). It contains recommendations for authorisation applicants in all phases, before or after authorisation.
Further details on the current FDA recommendations can be found directly in the draft guideline "Drug Products, Including Biological Products, that Contain Nanomaterials".
In this context please note the ECA, Loewe Center and Fraunhofer Institute joint conference on "Nano and Micro Formulations" on 13/14 March 2018 in Berlin.