Posted: Wednesday, 16th, 2014 | Filed under: Global Healthcare Market, Medical Regulatory Affairs, Advanced therapies, Biotechnology, CBER,CDER, CDRH, CHMP, Combination Drugs, Engineering, European Medicines Agency (EMA), Innovation, Innovation Task Force (ITF), Medical Devices, Nanomedicines, Nanotechnology, Nanotechnology Task Force (NTF), Regulation, Regulatory Affairs, US Food and Drug Administration (FDA) | author: Vrushali Tambe
Some of us may have seen the 1966 movie ‘Fantastic Voyage’ where a team of doctors was miniaturised and injected into a man to operate on a blood clot in his brain. This movie, although farfetched, showed a futuristic glimpse into the capabilities and applications of nanotechnology.
One of the most promising applications of nanotechnology is in Nanomedicines. Nanomedicines can be defined as the application of nanotechnology to medical diagnostics, therapies and prevention. The future applications of nanomedicines will involve engineered molecules to develop drugs, drug delivery systems, diagnostics, medical devices and advanced gene therapy and tissue engineering procedures.
Currently most regulatory agencies around the world regulate nanomedicines under the existing framework within established principles of benefit/risk analysis on a case-by-case basis. It is expected that many of the nanotechnology products will span the regulatory boundaries between drugs, medical devices, and biologics. As a result, these products are categorized as ‘combination products’ and are regulated under the rules established for such products.
The European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) has adopted a multidisciplinary approach for regulation of nanomedicines. Recommendations from the CHMP have already led to the approval of a number of medicines based on nanotechnology. The EMEA has created the Innovation Task Force (ITF) to provide a forum for early dialogue with applicants on regulatory, scientific or other issues related to the development of emerging therapies and technologies, including nanotechnologies.
Within the Food and Drug Administration agency of the United States, the Center for Drug Evaluation and Research (CDER); the Center for Biologics Evaluation and Research (CBER); and the Center for Devices and Radiological Health (CDRH), which regulate drugs, biologics, and devices respectively, are primarily responsible for regulating nanomedical products. The FDA’s Nanotechnology Task Force (NTF) helps assess queries on nanotech products and provide scientific guidance.
The regulatory agencies have encountered several challenges in development of robust regulatory guidelines for nanomedicines. Arguably, the most crucial of all is the classification of nanomedicines. Some nanomedicinal innovations may fall within several categories of regulation which may apply simultaneously. Therefore, not only is there ambiguity on applicability of the regulations, but there also could be an overlap of several regulations together.
There are several other gaps such as the methods used for characterization of nanomedicines, the standards used and the detection and measurement techniques; which need to be filled by research. More studies need to be performed to learn about the biological interactions of nanomedicines within the body and how cells respond to nanoparticles.
Another problem encountered is the availability of scientific expertise for the evaluation of applications for nanomedicinal products. Although there are few experts available in the academic world, there are still fewer industry experts who can guide on the suitable regulations for assessment of nanomedicines.
Then there are the social and ethical issues associated with nanomedicines which the authorities need to address. The question on environmental impact of nanomedicines also persists.
Since major regulatory agencies worldwide are struggling simultaneously with issues related to regulation of nanomedicines, they could benefit by sharing their knowledge and attempting to harmonize the regulations for evaluation of these products. The ultimate aim of the regulatory agencies is to promote innovation in this emerging field and to ensure public health and safety at the same time
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