Choosing the Right Reference Member State for Your DCP

When you plan a Decentralised Procedure (DCP), selecting the Reference Member State (RMS) is one of the earliest and most important strategic choices you will make. The RMS does not just validate your dossier. They lead the scientific assessment, coordinate with Concerned Member States (CMSs), and manage how disagreements are resolved. In practice, they set the rhythm for the entire procedure.

An experienced RMS can make the process efficient and predictable. They know how to balance strict compliance with practical communication, anticipate concerns from CMSs, and guide scientific discussions to consensus. The result is a smoother path to approval and fewer surprises.

A poor RMS choice has the opposite effect. Procedures drag, additional questions pile up, and consensus becomes difficult. Instead of accelerating your market entry, you spend months resolving preventable obstacles. In some cases, the wrong RMS has been the difference between a coordinated approval and a stalled procedure.

This strategic decision determines whether your new MAA progresses with momentum or gets caught in avoidable delays. Choosing the right RMS means choosing predictability, speed, and a higher probability of success.

The RMS Role & Responsibilities

The Reference Member State is the authority that takes ownership of your Decentralised Procedure. Formally, the RMS evaluates the dossier, issues the preliminary assessment report, coordinates responses from Concerned Member States, and leads the scientific discussion. In short, the RMS keeps the procedure on track and ensures assessments remain consistent across all CMSs.

Beyond this formal role, each RMS brings its own working style shaped by experience, culture, and capacity. Some are known for their clear communication and constructive mediation, while others are known for their rigid interpretations that prolong debate. A strong RMS can resolve issues before they escalate, while a weak one risks delays and added scrutiny.

In an ideal situation, the interaction between RMS and Marketing Authorisation Holder is balanced, with responsibilities clearly defined on both sides. The table below shows how activities are shared and where expectations should be set.

For executives, this mix of technical authority and soft diplomacy is what makes RMS selection so consequential. The right RMS not only provides a sound scientific evaluation but also creates an environment where consensus can be reached efficiently. The wrong one leaves you vulnerable to miscommunication, conflicting demands, and prolonged timelines.

Regulatory Performance & Track Record

For executives, the key takeaway is simple: RMS selection should be guided by both performance data and relevance to your dossier. A strong RMS cannot rescue a weak file, but a poor RMS can make even a strong dossier difficult to defend.

Not all RMS authorities operate with the same level of experience or efficiency. Some national agencies manage hundreds of procedures a year, while others handle only a few. This difference matters. Authorities with high RMS activity have more routine in managing timelines and coordinating CMSs. Less experienced authorities are more likely to escalate questions or allow delays to build.

Therapeutic expertise

The most reliable way to assess RMS expertise in your therapeutic area is by reviewing the completed procedure lists published by CMDh. These records show which authorities have recently acted as RMS for products similar to yours. By checking for repetition in your product class, focusing on recent procedures rather than historical ones, and validating this experience through direct dialogue with candidate authorities, you transform RMS selection into an evidence-based process, rather than relying on reputation or assumption.

CMDh Statistics & RMS

CMDh statistics on RMS and CMS activity indicate which agencies assume the most leadership roles and in which types of procedures. Reviewing this data helps identify authorities with a proven record of handling generics, hybrids, or well-established use applications. Matching your product type with the RMS’s experience increases the chances of efficient evaluation and reduces the risk of unnecessary disputes.

How to use CMDh statistics in RMS selection?

1. Identify active RMS authorities – look at which NCAs most frequently take the RMS role. High numbers signal routine and experience.
2. Match procedure types – filter for authorities experienced in the type of application you plan to submit (generic, hybrid, well-established use).
3. Check recent years – focus on the most recent 2–3 years of data, since agency resources and focus areas can shift.
4. Benchmark against peers – compare candidate RMS authorities to see which have a stronger track record for your product class.
5. Combine data with dialogue – use the numbers to build your shortlist, then validate by contacting the agencies to confirm availability and interest.

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In practice, the best assessment combines numbers with context. High procedure volume signals experience, but relevance to your therapeutic area and dossier type is equally important. For example, an RMS with broad experience in generics may not be the best choice for a hybrid with complex bioequivalence data. An authority with targeted expertise in your product class is more likely to anticipate issues and guide CMSs toward consensus.

Practical Considerations & Affiliates

Selecting an RMS is not necessarily just about scientific experience. Day-to-day practicalities can significantly impact the efficiency of the procedure. These are often overlooked, but they matter once the procedure is underway.

Here are 10 practical checks to get you started when evaluating a potential RMS:

1. Will the RMS communicate fully in English, or will some parts require input in the local language and translation?
2. Do you have an affiliate or partner in the RMS country who can handle signatures, correspondence, and payments on your behalf?
3. Has the RMS confirmed they have capacity within your planned submission window?
4. How early must you request a slot, and what is their track record of accepting new procedures?
5. What are the RMS’s fees, and how do they compare with those of other candidate authorities?
6. Are there any additional costs, such as portal access, notarization, or courier requirements, for original documents?
7. Does the RMS use electronic submission systems your team is familiar with, or will training be needed?
8. How proactive is the RMS in mediating CMS questions and preventing escalation?
9. What is their usual communication style, written feedback, calls, or formal meetings, and how quickly do they respond?
10. Does the RMS have a reputation for rigid interpretation of guidelines, or are they known for constructive dialogue?

These questions provide a starting point to uncover risks that may not be obvious at first glance but can have a direct impact on timelines, cost, and predictability. CMDh document provides a good overview of slot request process.

Commercial & Market Fit

RMS selection shapes both the regulatory outcome and the way approval supports your commercial strategy. When the RMS country is part of your target market, the procedure naturally connects with affiliate coordination, pricing work, and launch preparation. This creates alignment between regulatory and business priorities and builds predictability into the process.

In product types such as generics and hybrids, the influence is especially tangible. The RMS assessment is anchored in the reference product authorized in that country. Its label, therapeutic claims, and safety information form the foundation of the evaluation and are carried into the harmonized text adopted by Concerned Member States.

For example, a company preparing a generic application selected an RMS where the reference product label contained broad therapeutic indications. That label became the basis of the evaluation, and the wider claims flowed through the procedure. The result was a dossier that supported stronger positioning across several markets and simplified both regulatory and commercial planning.

Building Your RMS Shortlist

RMS selection works best when it is approached as a structured decision. The most effective way forward is to identify two or three potential RMS countries early, review their regulatory track record, and confirm their capacity. This gives your team options if the first choice is not available, avoiding last-minute delays in securing a slot.

A strong shortlist is built on three elements:

• Regulatory data from CMDh statistics and completed procedure lists to identify active and experienced RMS authorities.
• Practical checks on language, affiliates, timing, fees, and communication style.
• Strategic alignment with your dossier readiness, therapeutic area, and commercial plans.

Once you narrow your shortlist, reach out to candidate RMS authorities early. Opening the dialogue in advance gives you a chance to confirm availability, surface potential concerns, and prepare your dossier so validation runs smoothly. Treating this as a proactive step turns RMS selection into a strategic decision that shapes both approval timelines and market entry.

Insuvia can guide you through this process. We work with Marketing Authorisation Holders to evaluate RMS options, build evidence-based shortlists, and connect with authorities ahead of time. With regulatory intelligence and practical insight combined, you can be confident that your RMS choice strengthens your licensing strategy. If you want to explore your options, start the conversation with an Insuvia expert and see how the right RMS selection positions your procedure for success.