Here's What You Need To Know About The Access Consortium Pathway

A conversation with Guriqbal Singh, RegWeb Consulting Services

When you’re seeking market approval in multiple jurisdictions at once, it’s helpful, at least, if all the agencies join the same calls together.

The Access Consortium, a work-sharing scheme between five nations founded in 2007, aims to encourage cooperation between sovereign states and reduce duplication for drug developers, which should help new drugs reach patients faster.

Australia, Canada, Singapore, and Switzerland formed the original cadre. The United Kingdom joined later, beginning work-sharing activities in 2021.

We heard about the consortium from Guriqbal Singh, a regulatory expert and the founder of RegWeb Consulting Services in Ontario, at the RAPS Convergence conference in Pittsburgh where he spoke about the novel therapies, biosimilars, and generic drugs that have been approved through the pathway. He agreed to follow up and answer questions about navigating the program. Here’s what he told us. Answers in the transcript have been edited for clarity.

How do companies enroll in or apply to the Access Consortium? Is there an application process? Do they have to qualify?

Singh: First, the company should self-evaluate their products. The company should be confident that their product is eligible for one of three pathways. The three pathways are for new chemical entities, generics, and biosimilars, and they all have different conditions that a company must be sure it can meet.

To enroll, a company should submit an expression of interest. That’s your first step to enrolling in the pathway. The process begins with early engagement when the company notifies the agency of their intent, aligns submission timelines, and designates a lead agency for coordination. From there, the agency conducts a joint review.

Is the process different based on the type of program you're pursuing? What are the critical issues drug sponsors should address in these meetings to avoid problems later?

Singh: Now, we are talking about pre-submission meetings. That is the second step for this program. They are an opportunity for the sponsor and cosponsor to understand the regulatory expectations of each agency. The best thing you can do is have this meeting simultaneously with all the agencies applicable to the countries where you're going to submit.

Suppose you are going to submit with two or three agencies — you can have a single meeting with all of them. Sponsors can ask for clarity on regulatory expectations like clinical compatibility, local labeling, product designation, such as generic product or bioproduct, and if any manufacturing or CMC declarations are required.

And there's another opportunity here for alignment on the submission timing, dossier expectations, and lead agency designation. There are five agencies, and one agency will become the lead for your review; pre-submission meetings are when we can ask who will be lead agency and how we will coordinate and set up communication channels. These are the critical questions we can ask about in these meetings to avoid any issues in future.

The Access Consortium includes five members: Australia, Canada, Singapore, Switzerland, and the U.K. You hinted at this earlier. — what if I want to market my product in just a few of those? Can I still take advantage of the consortium?

Singh: Yes, that is a possibility. A general requirement is that you have to choose any two agencies at a minimum.

The 180-day target for priority review seems ambitious. How often do agencies actually meet the timeline? What are the common bottlenecks that prevent a company from achieving it?

Singh: The 180-day timeline is not the agency's goal; it's a shared goal the sponsor and agency both have to meet. Suppose the agency sends a question to the sponsor, and the sponsor takes more time than expected to respond. In that case, the 180-day goal  is not achievable. So, both parties have to work together. There are so many things that can lead to delays, like dossier misalignment, resource constraints on both sides, either from sponsor or agency side, or lead agency coordination. These kinds of thing can extend the number of days. But that's why, as I mentioned, it’s a shared goal.

You mentioned that major differences between submissions may delay the process. What constitutes a major versus minor difference in practice and how do sponsors discern between them?

Singh: It is complex. Here’s how I define major and minor differences. A major difference can be substantial variation in data packages, like in labeling or regulatory positioning, which could lead to divergent interpretations. So, as an example, we’ll look at a difference in clinical trial populations. Suppose you have done a clinical trial in one population, which satisfies one agency, but another agency needs you to enroll a different population as well. That can be a major difference.

Others are efficacy endpoints, manufacturing-side details, and risk/benefit conclusions. Different countries have their own ways of determining the risk/benefit for their population. These are the major things that can trigger inquiries and delay joint approval.

Minor differences can be administrative or formatting-related discrepancies, country-specific Module 1 adaptations, or local contact details or minor linguistic adjustment. I think these are expected and manageable.

Despite all of the Access Consortium’s virtues, each agency still decides independently. How often do final outcomes differ between members? When divergence occurs, is there a typical reason why?

Yes, that’s a possibility. The agencies have not given any data on why one country approved and the other didn’t. They promote work-sharing, but each agency retains full autonomy. So, most reviews result in aligned approval.

There are minor cases where divergence occurs, but the divergence gets resolved before the conclusion. Issues are flagged during the review process. Some things get sorted out, and some things are worked on up to the final stage. In other instances, some agencies approved product in X time, and some agencies may delay their conclusions. That’s another possibility of divergence. Overall, there's not much data on that. Typically, they just flag it and try to resolve it along with the sponsor.

Can you talk about the inspection reliance incentives? If I have a commercial product right now and I just want to speed up my inspection timelines, can I participate, too?

There's no different process in the Access Consortium from existing GMP inspection reliance and mutual recognition. If you have a GMP inspection approved by one agency, it’s acceptable by other agencies as well. There is no need for dual inspection. Each agency’s GMP approval process is aligned so we save time.

The only thing they are looking at is whether the inspection is more than two years old. Inspection reports should be recent and not flag any issues. If it's well accepted by all agencies, it will help accelerate the approval pathway.

About The Expert:

Guriqbal Singh is the founder and director of RegWeb, a regulatory consulting firm in Ontario, Canada. He has been working in the pharmaceutical industry since 2006 with experience in international regulatory, CMC, and regulatory intelligence. He has extensive experience in the project management of regulatory maintenance activities for global markets involving initial MAA, variations, renewals, and responses to questions. He has conducted conformance reviews on regulatory dossiers and reviews of pre- and post-approval documentation for regulatory submissions. He is a subject matter expert for registration requirements in emerging markets with a special focus on ASEAN, APAC, GCC, and Africa. Reach him at guriqbal.singh@regweb.ca or 1-647-673-1718.