Filing Services – Mutual Recognition Procedures
Elc group helps leading pharmaceutical company to fast track EU marketing authorisation for a neurodegenerative disease drug
Using elc group to undertake a highly complex MRP to bring a generic medicine to market in 10 European states ensured the process was completed in a timely manner and with no delays
The Challenge
Navigate the complicated system of approvals needed to obtain marketing authorisation in 10 European countries for a generic neurodegenerative disease drug
As it began preparations to bring a generic neurodegenerative disease treatment to market in 10 European territories, this pharmaceutical company faced a number of challenges. Undertaking a Mutual Recognition Procedure (MRP) of this scale could potentially overwhelm the resources of its in house regulatory team.
The time and effort burden involved in compiling the documentation alone was just part of the challenge. Typically MRPs can take anywhere from 120 days to two years, and it was essential that a dedicated focus was maintained on each stage of the procedure process, and that any potential disagreements between Member States were managed in a timely and expert manner.
The company turned to elc group to provide the expertise, resource and on-going management of the entire MRP process proceeded without a hitch, ensuring it could go to market within anticipated commercial timeframes.
The Solution
Divesting the MRP to elc group delivered the expertise and resource needed to ensure the entire procedure was appropriately managed to completion, releasing the regulatory team to focus on the day-to-day business of the company
Using elc group gave the company immediate access to all the resources it needed to manage every aspect of this significant application. With a wealth of experience in preparing and submitting dossiers using the MRP system, elc group was able to provide insight, advice and guidance every step of the way, ensuring the MRP process proceeded to completion in the most time-effective manner possible.
Following a detailed review of the therapeutic area and an evaluation of the potential costs relating to the lead procedure, elc group was able to make a powerful recommendation on which country should become the Reference Member State (RMS) for the MRP.
Next, elc group prepared a detailed regulatory strategy, taking into consideration patent expiry dates, data exclusivity dates and the summary of product characteristics (SmPCs) for each member state which would consider the RMS product assessment report.
Alongside preparing the initial submission to the RMS, elc group took control of drafting all documentation relating to the procedure and the coordination of all applications across the 10 target member states. And with specialist representatives in each of the countries involved, elc group was able to ensure local liaison with all regulatory bodies was maintained at all times, responding quickly to ensure any potential delay was minimised. And with elc group managing the entire process, document translation and administration was managed on time as an integral part of the procedure.
The Result
The elc group solution delivered measurable cost savings, ensuring the submission and coordination of the MRP was maintained in seamlessly. From identifying the most appropriate RMS to undertake the initial product, to managing the RMS initial assessment report and authorisation to coordinating the requests to other Member States for mutual recognition of the assessment by the RMS, elc group managed the entire MRP process to completion.
The benefits of a fully managed MRP application service from elc group include:
- Resources to support multiple applications in the Reference Member State (RMS) and Concerned Member States (CMS)
- Release the in-house regulatory team from the administrative burden of undertaking applications for marketing authorisation in two or more EU states
- A dedicated team to focus on working in a positive and collaborative manner with the Reference Member State (RMS)
- Expertise at identifying the most appropriate RMS for the medicinal product
- Defining a regulatory strategy that minimises any risk of costly delay
- Comprehensive expertise at completing all documentation in local languages, and access to local country experts to manage relationships in each Concerned Member State (CMS)
- Certainty that resources can be ramped up and down at key points of the MRP
- Detailed guidance on all requirements needed to satisfy regulatory bodies with regard to marketing authorisations in two or more Member States