Regulatory Processes - what's your view?

What I currently find to a big challenge is understanding and finding my way through the regulatory process to take forward a product that we’ve developed in the lab into a clinical/commercial product.

I firmly believe that this is a challenge for many of us and takes a very long time. Funding for these steps is not easy to find/get and so potentially a lot of really good science and engineering gets stuck and not developed further.

I’d be keen to hear others’ views/experiences with this and potentially any ways in which you try to overcome this?

Best wishes,

Hi Rachel,
I assume that you refer to a product that is used in humans. The entire topic is an important one that I believe the community skirts around. It depends on whether the product is a biomaterial only, whether the material in the biomaterial has a track record in the clinic. Most importantly, is it a product that contains a drug (incl. growth factors, nanoparticles) that has/has not been used before. Does it contain cells, viruses or other biological entity.
Unfortunately, if it is anything other than biomaterial only, that has a history of use in humans, it will take time and cost quite a bit of money. What I think is an excellent review is found here -
I hope this helps…I do see avenues for clinical translation, although many boxes need to be ticked, including safety and validation of manufacturing and materials. The good news is a lot of that infrastructure has been developed, such as easy access to GMP-manufactured polymers, that can help us make new biomaterials that outperform gold standards.

Hi Rachel,

For many projects recently, we have worked with Dr Stephen Liggett at [REACH REGULATORY]. REACH REGULATORY has been recognised through professional awards (TOPRA) and they have been invited to speak at numerous business incubators in the UK, the Netherlands and France. REACH REGULATORY has extensive experience in Advanced Therapy Medicinal Products, Biologics, New Chemical Entities and Drug Delivery Systems leading regulatory engagements with the FDA, EMA and MHRA.

Thank you Paul, yes I agree but i have also recently found that even if it only contains a biomaterials but that biomaterial may have antimicrobial activity, for example, as an inherent property of the material - nothing is released - then it is more complicated and then they want to treat it as a drug. Is this correct?

I would check whether it has been used in the clinic to date…even if it was in a tissue that is not the one that you plan for, having some previous use in humans (without deleterious effects!) is an assistance. It is indeed a complex area, and one that I avoid by trying to stick with the known polyesters :-/ . There are some wise heads out there, like Richard McFarland at ARMI, who is familiar on this topic.
Best, Paul

This depends on the country (and in some countries, on region/Lander). The point under MDR 2017/745 is that you have to specify the primary function. I guess any biomaterial is not biomaterial alone, this is a part of a medical device. So what this medical device is for? Use the Rules of MDR and find the Class (I guess would be either IIa, IIb or III). This will tell what to be done.

Hi Paul, right we need to separate between MDs, pharma (“medicinal products”) and ATMP. The worst case if you have all three in the products, this would be a nightmare. And I am not talking here about REACH either, this is another story; dealing with 745 under Annex I is sufficient to get grey hear.

Hi Rachel,
I see you have received some really good advice. I can add some more thoughts and I apologize if they are redundant. You are in the best position to understand what your product is and what it does. You need to be able to describe its principal mode of action. What clinical problem is it intended to solve. There could be secondary and tertiary benefits to the product but those may be considered more for risk mitigation, etc. (do no harm). Pick a region or country in the world to focus on for regulatory purposes. Each country or region has similar regs, processes and procedures but they are also different so best to concentrate on one. If you really don’t know how the product would be viewed by a government agency or notified body then you probably need advice. In my experience the notified bodies in Europe are good at reviewing dossiers but are not in the business of providing advice. The US FDA on the other hand has created processes whereby you can ask for meetings pre-submission to get feedback on how they view your product and what they would expect to see for review.

This is a really complex area that I know from my experience with ATMP. I don’t know the properties of your product. Nevertheless, sometimes you should decide and declare if you have or not an active substance in/on your biomaterial. In the case of active substance - you should proceed with your product as a medicinal product; if not - as medical devices.