Seeking Harmonization in Nanomedicines Regulatory Framework - Pharmaceutical Technology

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Seeking Harmonization in Nanomedicines Regulatory Framework
Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.


Pharmaceutical Technology
Volume 37, Issue 8, pp. 28-30

EMA takes charge
Meanwhile, EMA has been stepping up its efforts to ensure a consistent EU-wide approach to nanomedicines in the two areas for which it has responsibilities—pharmaceuticals and combination products, defined as devices with a predominant pharmaceutical application. So far, EMA has only evaluated 11 marketing-authorization applications for nanomedicines, of which eight have been approved and three withdrawn. This number is fewer than in some of the larger EU countries. In France, for example, 36 nanomedicines, 21 of them being drug-delivery products, have been licensed.

EMA has recently drafted reflection papers (i.e., discussion documents on the principles underlining the risk assessment of groups of products that may provide a basis for later guidelines) on generic nanomedicines or nanosimilars. The agency is also planning reflection papers on new second-generation nanotechnologies, on which it has already published discussion documents on block-copolymer micelles and nanomedicine coatings. As a coordinator of evaluation strategies throughout the EU's network of national licensing authorities, EMA believes it is in a strong position to boost assessment standards in areas like nanomedicines.

"The agency has access to the best available scientific expertise in Europe, which it can consult during the evaluation of the quality, safety, and efficacy of all new compounds, including nanomedicines," an EMA official told Pharmaceutical Technology. "EU-wide harmonization is one goal of EMA. However, the agency's main intention is to ensure that only safe and efficacious medicines enter the EU market."

EMA's Committee for Medicinal Products for Human Use (CHMP) has a multidisciplinary expert group on nanomedicines, which can tap into the evaluation experience among member states. The agency has also been extending its regular contacts with non-European agencies on nanomedicines. CHMP chairs regular meetings on the matter with FDA and the licensing authorities of Japan, Canada, and Australia. "There are no official recommendations from these meetings," said the EMA official. "The focus is on knowledge-sharing and finding common areas for collaboration."

The reflective paper on block-copolymer micelles, written jointly by the agency and Japan's Ministry of Health, Labor, and Welfare (MHLW), was an idea that came out of one of the international meetings. The EMA's investigations of nanomedicines have highlighted the need for more public-sector assistance in Europe on the characterization of nanoparticles in medicinal products. The micelles reflective paper pinpointed the importance of characterization of approximately 15 properties of block-copolymer micelles and properties related to the manufacturing process and in-vivo behavior, as well as of the chemical structure and nature of the polymer raw materials.

The ETPN is currently exploring the idea of setting up a European Nano-Characterization Laboratory that would act as the centre of a network of characterization facilities across Europe. It would be modelled on the US National Cancer Institute's (NCI) Nanotechnology Characterization Laboratory (NCL), which has close links with FDA.

Europe is gradually putting together an evaluation structure that should accelerate the development and commercialization of the next generation of nanomedicines. "Like with all new technologies, there have inevitably been areas of uncertainty with nanomedicines," said Levy. "But ultimately, as knowledge of the technology increases, there will be a high level of consistency and clarity in the way it is regulated across Europe."

Sean Milmo is a freelance writer based in Essex, UK,


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