What Does An RMS Do?They act as:
- scientific assessor of a dossier
- regulatory advisor to the applicant
- moderator between applicant and CMS
Know Your RMSPrevious experiences with an HA can be of major advantage. These connections often make sure procedures move along according to the set timetables without any unforeseen trouble because you understand their point of view, they speak the same language so to speak. These professionals look out for, and mitigate, unforeseen delays due to their experience with that Reference Member State; they are familiar with their workload, approach, and the way they communicate.
Differences Among Health AuthoritiesAlthough we’re all in the EU, every member state is responsible for their own day-to-day business. Some might be better communicators, others more prone to act in a timely matter and others more inclined to be open to more pragmatic approaches. Companies are especially recommended to check the pass-through times and a backlog of a possible new RMS and are required to contact the Health Authority in advance to check their availability to take over as Reference Member State for existing procedures. Besides there is also a difference in not every HA has extensive experience acting as an Reference Member State at all.
If The RMS Has Experience In A Therapeutic AreaSome RMS have more experience than others in certain therapeutic areas. If you are you a generic manufacturer you might want to check the originator’s Reference Member State; which is often also the RMS for other generics. This is noticeable when an originator product goes off-patent because almost all generics manufacturers will tend to apply with this same RMS with which the original was registered. Other questions to consider, include:
- Does a Health Authority have a special focus regarding specific therapeutic areas?
- Have they been involved in the development of certain guidelines?
- If the new RMS is going to be one of the current CMS, recall what the attitude towards the product was during a previous application.
Location Of The CompanyThough it might seem like an open door, avoiding language barriers and having the proper infrastructure in place is always a benefit to the daily business. It’s also strategic to choose your Reference Member State according to your company’s EU affiliates; opening up the possibility of direct communication with the HA. Increased contact and the ease of face-to-face counsel can contribute positively. This is especially useful considering we’re working in a regulatory universe that seems to thrive mainly on communication through elaborate documents. Besides these advantages, it also allows affiliates to join the strategic conversation with HQ and to increase their visibility and experience.
Commercial ReasonsLast but not least: financial gain. There are several commercial reasons to interact with a certain RMS; straight-forward aspects like fees charged by Health Authorities, the market size of the Reference Member State and are there key opinion leaders available? Some practicalities to keep in mind:
- there can be no change of RMS during an ongoing procedure (of importance for timing/planning);
- it is the obligation of the MAH to ensure that both the current RMS and the future RMS accept the change of RMS;
- it is the responsibility of the MAH to supply to the new RMS if any dossier/ assessment reports or other relevant materials are missing or for any reason not already in possession of the new RMS.