EU To Test Merging & Splitting Of Licences Under Mutual Recognition/Decentralized Procedures
This article was originally published in SRA
The CMDh - the EU group that co-ordinates the approval of human medicines evaluated through the mutual recognition and decentralized procedures - has launched a pilot project that will allow drug companies to merge or split MRP/DCP lines to suit their business strategies1.
The concept of merging or splitting MRP/DCP lines is new and it is being piloted in recognition of the fact that a company's marketing strategy tends to evolve with changing market needs and requirements.
Depending on the company's business strategy, for example, initially there may be just one application and a large number of concerned member states (CMS) in a DCP, or there might be several parallel DCPs with just a few CMS. Subsequently, after the market entry of these marketing authorizations, there may be a need for "adaptations" to facilitate the handling of these procedures in the future lifecycle, the CMDh says.
In cases where companies are merged, for example, the merging of the DCP lines may be advantageous for marketing authorization holders (MAHs). In specific situations, the merging of several parallel MRP/DCP lines belonging to the same or different MAH may facilitate the handling of post-authorization procedures, such as renewals or variations, the CMDh explains.
In cases where additional MAHs are introduced into one procedure, splitting of a DCP line would lead to several independent marketing authorizations (eg, one for each MAH), which could facilitate the submission of future variations and save unnecessary expenses, the CMDh says.
The concept of splitting can also be useful in cases where the marketing authorizations of a MRP/DCP are sold to different MAHs for specific EU member states and the new MAH is planning on different development routes for these products. "In these cases a splitting of a MRP/DCP into several smaller lines seems to be reasonable for preventing MAHs from unnecessary variation procedures for their products and for keeping the dossiers clear," it adds.
After finalization of the pilot phase, the CMDh says it will discuss the workability of this concept for national competent authorities.
Long Standing Industry Demand
The CMDh pilot stems from a proposal made by the European Generic and Biosimilar Medicines Association (EGA) in its "regulatory efficiency report" issued last year that identified several opportunities for improving the current regulatory system for generic companies2.
Among other things, the EGA report called upon regulators to rapidly introduce a mechanism to "link and de-link" (ie, split and merge) the marketing authorizations in DCP to align with company needs and simultaneously remove any redundant marketing authorizations and reference member state roles.
The EGA welcomed the fact that the CMDh has taken its suggestions on board and is testing the concept of merging and splitting MRP/DCP lines through the pilot.
The limitations in the current DCP format mean that "some medicinal products end up being part of several DCP procedures. This leads to a multiplication in the number of post-approval variations submitted and also each applicable Reference Member State having to write an assessment report," explained the EGA's deputy director general and head of regulatory affairs Beata Stepniewska.
To address this problem, the EGA had proposed "that an optimisation is adopted" by enabling a merger of DCP lines, with a single RMS chosen by the applicant then taking lead responsibility for the product. "This would be another utilisation of work sharing and would lead to measurable regulatory workload reduction, particularly for the [national drug regulatory] Agencies, as well as for industry," Stepniewska told Scrip Regulatory Affairs.
Also, the EGA had suggested that there should be flexibility to de-merge or split DCPs in situations where a company wishes to separate marketing authorizations in one or more country, for example, if a part of a company is bought or sold, or in cases where an R&D developer licenses out one DCP wave to more than one marketing company.
The EGA believes "a combination of merging and de-merging DCPs would drive a rapid consolidation in the total number of DCPs" and would also help reduce the overall regulatory complexity in the system. The concept, it said, would sweep away the use of parallel reference member states for the same dossier and remove redundant marketing authorizations.
The Pilot
Companies interested in participating in the pilot are being asked to contact their respective industry associations instead of approaching the CMDh directly.
The concerned industry associations, in turn, have been asked to prepare and submit by 18 March a consolidated list of mutual recognition/decentralized procedures they want the CMDh to consider for the pilot. For each procedure proposed for the pilot, a short explanation or justification is needed explaining why the MR/DC procedure should be merged or split.
Stepniewska said that the EGA had already received "several candidates for the pilot" from its member companies, which will be communicated to the CMDh very soon.
The CMDh has specified certain conditions that must be met in order for the proposed MR/DC procedures to be considered for the pilot phase. Based on the consolidated lists submitted by the associations, the CMDh will decide on which procedures to include in the pilot phase, which is currently restricted to 10 MR/DC procedures for merging and 10 for splitting.
Following an agreement on the proposed procedures to be merged or split during the pilot phase, the concerned MAHs would be informed about the decision and would have to update the package leaflets of the affected products within a specific deadline.
References
1. CMDh Working Document on Merging and Splitting of MRP/DCPs (CMDh/343/2015, Rev.0), December 2015, www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Advice_from_CMDh/CMDh_343_015_Rev0_2015_12.pdf
2. EGA Regulatory Efficiency Report 2015, Site accessed Jan. 5, 2016, www.egagenerics.com/EGA_Regulatory_Efficiency_Report/#1/z