I've been participating in the Asia Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee since the Russia year in 2012 and I can honestly say that my efforts over the past seven years are finally paying off.

In the policy world it's quite often hard to measure success. You have a position or policy that you think is right, you build the relationships that you think will be able to affect change, and then you go about trying to convince the "right" people that you're right. And sometimes, just sometimes, after many years, you see that position of yours pop up in legislation or regulation somewhere. That is, if you're lucky. I got a little lucky.

APEC is a voluntary international trade and economic forum. It has 21 member countries, or economies as they are called in APEC. You can get a list of the 21 economies at this link. Suffice it to say that nearly all of the world's major commercial markets are included in this forum. In 2012, I reluctantly attended my first APEC meeting in St. Petersburg Russia. Mainly because my previous interactions with other multilateral forums hadn't really yielded many results. But I was an invited guest and the topic was regulatory harmonization of health products within the region. The idea was that harmonization of regulatory systems in the region would result in more efficient and timely approval of much needed medicines and technologies for the region's population. This was perfectly in line with the goals I had in my own organization, and so I accepted the invitation. What I found there was surprising. Where I had been met with skepticism and suspicion in other multilateral forums, I was welcomed with enthusiasm and credence at APEC. Why? Because regulatory harmonization was their idea and they were interested in advancing it.

Thus began my 7 year interaction with the organization as a member of the Regulatory Harmonization Steering Committee (RHSC). This policy making committee sits under the Life Sciences Innovation Forum which is a tripartite group within the APEC Health Working Group. What this means in layman's terms is that the committee consists of regulators, industry and academia, and it actually sets policies that APEC can adopt. Over the past 7 years I worked alongside regulators from more than 16 economies, other industry colleagues and academic institutions to identify regulatory gaps within the region and to create a pathway and mechanism towards convergence.

The committee identified 7 areas where convergence would yield effective results. They are: Global Supply Chain Integrity, Biotherapeutics, Multiregional Clinical Trials, Advanced Therapies, Good Review Management and Good Clinical Practices, Pharmacovigilance, and Medical Devices. Once these areas were identified, the committee set about devising an action plan to close the regulatory gaps. The first order of business was to determine exactly what standards the region would converge towards. Fortunately we have a significant body of excellent work already to draw from. The International Council on Harmonization, the World Health Organization, the International Medical Device Regulators Forum, all are widely accepted, and all have published standards or guidelines in most or all of these areas so there was no need to create any new materials. The committee quickly matched the appropriate guidelines with the gap areas and then set about finding ways to close the gaps.

This took the lions share of the effort, as the capacity level of the region is so diverse. For example, the US FDA or Japan's PMDA may be confronted with different types of applications, and may have different experience levels, than that of the Drug Administration of Vietnam or FDA Thailand. There would need to be large scale training of regulators in the relevant guidelines to equalize the experiences. Hence the committee decided the best way to implement convergence would be through the creation of APEC Centers of Excellence (CoE) in all of the identified areas. This was a lengthy process. Advisory committees were created, institutions with training capability were identified, curricula were developed, faculty was identified, and pilots were launched.

Today, after 7 years, APEC boasts 12 Centers of Excellence for Regulatory Sciences across 7 APEC economies. In 2019 these CoEs will host 23 workshops which will train hundreds of regulators. These CoE's are managed by the APEC RHSC with the help of the APEC Harmonization Center, which is generously funded by the Korean government (Korea is an active member of the APEC RHSC). The CoEs all must train using an APEC approved core curriculum in the gap areas. The curricula for each of these areas was painstakingly developed by experts from regulatory agencies, industry and academia and was approved by the APEC RHSC, and is taught to regulators by the CoE in their region. To make it more convenient for the regulatory authorities, some CoEs are even equipped to take the training in house as well. And there is even travel funding available for those regulatory authorities that may not have adequate resources to send regulators to training. The group thought of everything!

I just returned from a meeting of the APEC meeting in Puerta Varas Chile where the results of this effort was finally unveiled at the Policy Dialogue on Innovation, Regulatory Systems and Regulatory Convergence. A survey of the regulatory authorities of all APEC economies showed that using measurable performance indicators, there was marked improvement in convergence since the beginning of this project.

There has been improvement across all 21 economies in information sharing, in establishing confidentiality agreements, in sharing good manufacturing practices certificates, in establishing Mutual Recognition Agreements, in minimizing Certificates of Pharmaceutical Products, and in allowing multiple sites in single licenses. This was so gratifying for me, and for all the others, to see the results of our hard work.

Is there more to do? Of course! At the same meeting in Chile, the group decided to add CoEs in parts of the region that were lacking CoEs, namely in Latin America, and to expand its reach to outside the APEC region as well. The group also decided that additional performance indicators such as "reliance" should be included in future assessments. The group also agreed that the region should engage in "Horizon Scanning" in order to prepare for the innovative medicines coming down the road. Genome editing technologies and artificial intelligence are changing the face of medicine, and the regulatory authorities' pipelines will look very different in 5 years than they do today. There is definitely much more to do.

But the work that's been done so far is encouraging and exciting. Through the good work of APEC, regulators across the region are communicating with each other better, they are building confidence in each other's capabilities, and they are working to streamline their practices. The true indicator of all these efforts is whether a patient who needs a medicine or device has access to it, but that is for another forum. The APEC regulators can honestly say they are doing their best.