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The ECA RMM Working Group was founded on 7 June 2006 at the German Federal
Agency for Sera and Vaccines by 11 representatives from the European
Pharmaceutical Industry and the German Federal Agency for Sera and Vaccines,
the Paul-Ehrlich-Institute (PEI).
During its inaugural meeting the working group reviewed the current
situation of RMMs in Europe and defined a work plan.
One of the current issues the group identified is the lack of
standardisation for the submission of RMMs. The group also considers the
integration of certain methods into the European Pharmacopoeia chapter 5.1.6
as critical because it possibly sets a wrong focus on these tests only. In
addition, the use of RMMs for marketed products is discouraged by the Type
II Change effort. The group also voiced concerns about the inappropriate
methods occasionally requested by the authorities – like classical EP
sterility tests for cell therapy products. In general it sees a clear
forward path for using RMMs for new submissions.
To develop a work plan also representing the industry’s point of view the
group conducted a survey in one of ECA’s Masterclasses and over the internet.
The result representing close to 40 major European pharmaceutical companies
and biotech start-ups across Europe showed that many companies plan on
introducing RMMs in the next 1-3 years, and that most of them want to apply
them for environmental monitoring and to focus on quantitative methods. Most
companies also expressed that there’s not enough regulatory support to drive
a change quickly and that a clearer regulatory guidance would accelerate
methods introduction. According to the survey companies also perceive the
approval process as complex, thus delaying introduction. In that respect a
clear expectation for adopting RMMs on the authorities’ side would strongly
influence many companies’ thinking.
To help both authorities and industry get a better understanding of the
requirements for the introduction of RMMs and to provide them with guidance
based on case studies and available experience, the group will establish a
Best Practice Guide. In two main chapters the guide will concentrate on
traditional drugs and new drugs with their particular aspects and
requirements. “We also want national agencies and inspectorates to be
involved. We’ll thus plan on discussing first drafts with representatives
from EMEA, EDQM and national authorities”, said Mike Edgington, Director for
Regulatory Affairs, ECA. To share information from the guide with both sides
the ECA will also organise webinars and courses. In addition the group plans
on publishing articles in European pharmaceutical industry publications.
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