Virtual RSNN expert meeting on NBCDs
On 8 December 2020, the Regulatory Science Network Netherlands (RSNN) will organize a virtual expert meeting on non-biological complex drugs (NBCDs).
New therapeutic modalities are becoming increasingly complex, with more and more use being made of so-called nanotechnology. We are now seeing generic versions of the first generation of complex products coming to the market. Many of these products are non-biological complex drug products. Due to the complexity of NBCD products and because the biological activity is not always directly related to the pharmacokinetic data, there are many challenges in developing NBCDs.
Because of the fast-growing market of nanomedicines, which includes many of the NBCDs, it is essential that we have the right knowledge and infrastructure, as well as suitable regulatory instruments to make complex products available to the patient in the best and most efficient way. In other words: how do we place these complex products in the current regulatory system, and can we balance sufficient scientific substantiation with an efficient authorization procedure?
Within the framework of this RSNN expert meeting, we want to contribute to the discussion and knowledge development about the current challenges of authorization procedures for complex generic products (such as NBCD follow-on products).
This Expert meeting is invitation only, but outcomes of the meeting will be presented in a meeting report published on the RSNN website.