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Regulations for complex drug products; is global alignment in sight?

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Jon de Vlieger, Director of Business Development and Coordinator of the Non-Biological Complex Drugs (NBCD) Working Group at Lygature, was invited to present at two high-profile international meetings, where he shared his views on regulations for complex drug products. Read more in his blog below.

Nowadays, globalization is integrated in the way we think, act and plan for new activities. Major health and environmental challenges can no longer be solved on a ‘country-by-country’ basis. They demand coordinated global action. To solve these challenges, we must discuss how to arrive at joint policies and regulations. Over the last two months, I was fortunate to be able to speak at two high-profile meetings – the Global Summit on Regulatory Science (GSRS) in Stresa, Italy, and the American Association of Pharmaceutical Scientists (AAPS) PharmSci 360 meeting in San Antonio, USA. Both meetings provided an excellent platform for discussions with all the relevant parties, including representatives from regulatory authorities and industry, other scientific experts, and stakeholders from countries around the world. Collectively, we shared the latest insights, discussed bottlenecks in current practice, and started to brainstorm what future regulations for complex drug products might look like.  

My presentations focused on regulations for nanomedicines, nanosimilars and non-biological complex drugs (NBCDs). For these complex products, different regulatory approaches are currently used in different parts of the world, leading to different regulatory requirements for the admission of such products to individual countries. This is suboptimal, because it creates uncertainty among those involved about how these products should be developed.

One thing we could do is build upon our collective experience of regulation for other complex products, such as biologics and their similars. In my opinion, we should use that experience. In order to do so, I strongly believe it is crucial that all the involved parties meet early on in the development process to shape a coordinated global approach. When it comes to topics such as the use of new technologies in the development of medicines, we should grasp the opportunity to do just that. Let’s have the discussion and jointly shape new policies and regulatory guidance before everyone has already taken their own position on the topic.

Looking to the future, I expect that the increasing complexity and diversity of medical products will demand that we thoroughly review our current practices. In particular, these complex modalities will continue to challenge current regulatory frameworks for new and off-patent drugs. There are several questions that we need to find answers to. Which product characteristics are essential for the intended therapeutic performance? How do we determine these characteristics, and which scientific approaches are appropriate to establish similarity between a follow-on product and the reference listed drug?

The GSRS 2019 meeting in Stresa clearly provided food for thought, and the lively discussions at the event demonstrated the collective energy to continue the dialogue on this important topic. The AAPS PharmSci 360 meeting convinced me that a very strong technology push, in terms of developing new therapeutic modalities as well as new analytical tools to characterize complex products, will continue to challenge current regulatory frameworks. I’m also convinced that the efforts of international experts, such as those convening in the NBCD Working Group, really can make a difference when it comes to ensuring the implementation of science-based regulations worldwide.

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