EMA's Modeling & Simulation Group Gears Up For Bigger Role With New Status
Executive Summary
Modeling and simulation approaches are expected to play even a greater role in regulatory decision-making by the European Medicines Agency in the coming years.
The European Medicines Agency has converted the working group that its medicines evaluation committee, the CHMP, consults on modeling and simulation approaches into a temporary working party to reflect the greater role such approaches are expected to play in regulatory decision-making over the coming years.
The transition of the Modelling and Simulation Working Group into a temporary working party recognizes "the added (current and expected) value that the group brings to the Agency," an EMA spokesperson told the Pink Sheet.
The MSWG was first established in 2013 and it has already contributed substantially to the EMA's work, according to the spokesperson. Because modeling and simulation approaches are expected to have an even greater impact on regulatory decision-making in the coming years, the group’s status has been changed into a temporary working party, which compared to a working group, is more involved in the CHMP's work.
The new temporary Modelling and Simulation Working Party is being chaired by Kristin Karlsson of the Swedish Medical Products Agency, and its vice-chair is Musuamba Tshinanu of Belgium's Federal Agency for Medicines and Health Products. The proposal to convert the MSWG into MSWP was made in April.
In the past, the MSWG has offered advice on modeling and simulation approaches that are playing an increasingly important role in regulatory decision-making when it comes to topics such as study optimization; extrapolation of data from adults to children; drug-drug interactions; dose/posology recommendations; QTc interval prolongation risk assessment; and medicinal product lifecycle management.
The CHMP has routinely consulted the MSWG on these approaches, especially with regard to scientific advice and requests for pediatric investigation plans that are mandated under the EU Paediatric Regulation, the spokesperson noted.
According to the EMA, drivers of modeling and simulation approaches are:
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- The exponential increase in computing power and data that is generated pre- (e.g., omics data) and post-marketing authorization (wearable devices, electronic health records).
- The recognized need to bring innovative and lifesaving products earlier to the patient (such as through the agency’s priority medicines (PRIME) scheme);
- The European Commission’s Horizon 2020 program, with regard to its focus on in silico trials, personalized medicines, and extrapolation.
Working Groups Versus Working Parties
Standing and temporary working parties have a greater involvement in the CHMP’s work compared with the committee’s working groups.
In the MSWG's case, the transition to working party status has been seamless and is not expected to affect its current functioning as the group's involvement in development of guidelines and product related discussions has already been substantial, the spokesperson said.
For example, the MSWG was instrumental in the development of the EMA's Extrapolation Reflection Paper, together with the agency’s Biostatistics Working Party and the extrapolation group, and the physiologically based pharmacokinetic (PBPK) modeling and simulation guideline, together with the Pharmacokinetics Working Party. (Also see "EMA Keeps Hold Of Extrapolation Template So Pharma Doesn't Lose Pediatric Focus" - Pink Sheet, 27 Oct, 2017.) (Also see "EFPIA Picks Holes In EMA's Pediatric Extrapolation Proposals" - Pink Sheet, 19 Feb, 2018.)
The MSWG has helped increase the capacity of the EMA regulatory system towards modeling and simulation and made significant steps towards streamlining how these methods are assessed in the EU regulatory network (e.g., through Q&A documents and assessors' trainings), the spokesperson added.
In addition, pharmacometrics/modeling and simulation cluster teleconferences with the US Food and Drug Administration, Health Canada and Japan's Pharmaceuticals and Medical Devices Agency have also ensured international collaboration in the area.
EMA working groups are established to provide expertise in their respective areas, and the CHMP consults these groups and delegates to them certain tasks associated with marketing authorizations, other regulatory applications, and the drafting and revision of guidance documents. Temporary working parties, on the other hand, are established on an ad hoc basis to help prepare proposals on a specific scientific topic, respond to specific questions raised by the CHMP, and draft or revise guidelines.
From the editors of Scrip Regulatory Affairs.