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Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.
Q. Our company is a young, modern enterprise, and our management decided to apply modern, state-of-the-art technologies and methodologies in our manufacturing facility. We have installed automated systems that allowed us to establish process analytical technology (PAT) to formulate a quality-by-design (QbD) approach and enable us to perform parametric release. We intend to submit our application in the United States and in Europe in 2019 or 2020. We were advised by consultants to seek advice from the regulators to confirm that we are on the right track. However, our senior management rejects this idea. Can you give any advice on how to convince them otherwise?
A. First, let me congratulate your management on being a progressive company that embraces modern technology and science as promulgated by regulatory agencies around the world. Though regulators encourage the industry to leverage automation and new technologies, they themselves are not necessarily that familiar with these and may find it difficult to understand the full impact each of them has on product quality and, thus, patient safety. So the question is: when are you going to tell the agency about your innovative approach, at the time of the submission or before?
Regulatory agencies, including FDA, the European Medicines Agency (EMA), and the national authorities, all offer scientific advice-all prior to an applicant submitting an application. There is a good reason for that, namely that the regulators are interested in assuring that when they receive an application, it not only complies with the regulations, but it also meets the agency’s expectations. Though the healthcare regulations are detailed, they can never cover each and every aspect of the drug lifecycle. There is always room for ambiguity and interpretation. If these issues can be addressed well before an application, then so much the better, as they will not unnecessarily delay the approval of your drug. A win-win situation one should assume.
So why not take advantage of the offering? Maybe there is a thorough belief in one’s capabilities and approach to compliance. Maybe you don’t dare ask for fear of asking a silly question? Remember the old adage: There’s no such thing as a silly question! Avoiding an uncertainty warrants certain disaster. Maybe you expect your questions will not be answered. You won’t know until you have tried asking. Maybe you fear you may not like the answer. Isn’t it a lot better to know about the agency viewpoint early on?
Clearly, there is a good case for seeking a meeting with the agencies to present your innovative approach. Yes, a lot rides on preparing thoroughly for such a meeting, making sure you present clearly, succinctly, and convincingly. Make sure you seek feedback on those areas that you think may get challenged.
Even if you still cannot convince your senior managers of the undoubtedly great benefits of seeking regulatory advice through such meetings, you can still pursue some alternative channels. These include attending conferences or workshops, where you can meet with peers and regulators, thereby exchanging views and seeking feedback. Or you could actively engage in (special) interest groups through industry associations. You may not get feedback from agency staff, but certainly from industry peers.
It’s usually better to ask than to run into unexpected issues with regulatory agencies at the time of your submission. Every day your drug approval is delayed is not only a day of no revenue, it is one day more the patients have to wait for your product.
Vol. 31, No. 7
When referring to this article, please cite it as S. Schmitt, "Seeking Regulatory Advice," BioPharm International 31 (7) 2018.