Around the Globe

Regulatory Reliance Also Applies to Mature Regulatory Agencies

Thomas Kühler
Sanofi R&D


t a recent symposium about expanding regulatory innovation, I discussed the importance of Regulatory Reliance, defined by WHO as, “The act whereby the NRA in one jurisdiction may take into account and give significant weight to assessments performed by another NRA or trusted institution, or to any other authoritative information in reaching its own decision. The relying authority remains independent, responsible, and accountable regarding the decisions taken, even when it relies on the decisions and information of others.” This approach offers a true win-win opportunity for all parties involved – notably to society and patients, who depend on timely access to high-quality, innovative, safe, and efficacious medical products.

But it doesn’t stop there: Through Regulatory Reliance, regulators can avoid duplication of work while maintaining sovereignty over the decision-making in the jurisdiction they are overseeing. Regulatory Reliance is an effective means to manage resource capacity and avoid stretching resources too thinly. Effective stewardship can reduce the regulatory burden and strengthen the regulatory setup globally; and it can be applied at any stage of the product lifecycle, starting with the initial marketing authorization through renewals to line extensions and variations. Managed properly, resources could be pooled, allowing for more rapid, while still thorough, assessments. The developer would not have to engage in repeat filings (a rather burdensome workload when it comes to managing post-approval changes), rounds of Q&A that are identical or very similar in nature, or multiple pre-approval site inspections, to name but a few.

Regulatory Reliance is something that the EMA, WHO, and PAHO, among others, are advocating for – and not only from a resource perspective. Indeed, the WHO recently reported that approximately thirty percent of regulators globally have limited capacity to perform core regulatory functions. The notion that not all regulators can have all the expertise needed was also reiterated severalfold at the symposium that I attended.

Let’s do away with the lingering myth that Regulatory Reliance is something for evolving regulators only. This is not true. Regulatory Reliance is suitable for any regulatory authority, irrespective of their maturity level. The principles of Regulatory Reliance apply equally to evolving regulators as to those that are well established and recognized.

In light of the above, it was rather gratifying to note that the UK Department of Health and Social Care just published two international collaboration initiatives akin to reliance and work sharing that will enable the MHRA (the Medicines and Healthcare products Regulatory Agency), which is responsible for regulating all medicines and medical devices in the UK, to expedite the evaluation of new treatments. These are the project ORBIS and the ACCESS consortium.

Project ORBIS was initiated by the FDA Oncology Center of Excellence in 2019 and provides a means for simultaneous review of oncology products for those agencies that have joined the project; currently Canada, Australia, Switzerland, Singapore, and Brazil – and now also the UK. The premise is that this collaboration will allow faster access of novel therapies to patients with cancer.

The ACCESS consortium states it is “a medium-sized coalition of ‘like-minded’ regulatory authorities that work together to promote greater regulatory collaboration and alignment of regulatory requirements.” The collaboration dates to 2007 when the regulatory authorities of Australia, Canada, Singapore, and Switzerland got together and started a collaboration under the acronym ACSS. The group will expand its reach when the UK national regulatory authority joins the consortium.

Both Project ORBIS and the ACCESS consortium are excellent examples of Regulatory Reliance with the ultimate goal of reducing duplication of work while increasing each agency’s capacity to ensure that patients have timely access to high-quality, safe, and effective therapeutic products. Notwithstanding, MHRA will maintain full authority over the final decision whether or not to authorise medicines onto the UK market.

The above announcements are important from a Brexit perspective as these are steps towards ensuring that the UK regulator will remain at the forefront of both regulatory science and new product development in the future. Perhaps these new collaborations will prove to be an element of friendly competition with the EU regulatory network. Competition has always worked in favour of mankind, and I believe it will do so here as well.