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To change the unfavourable competitive situation for the European pharmaceutical industry the European Compliance Academy (ECA) initiated a Rapid Microbiological Methods (RMM) Working Group. The group brought together 11 representatives from the European Pharmaceutical Industry and the German Federal Agency for Sera and Vaccines, the Paul-Ehrlich-Institute (PEI); the European authorities will also participate. To accomplish its goals it will support the industry to increase drug quality and reduce costs by implementing new technologies as rapidly as possible. On the other side the group will also provide regulatory agencies sufficient information within a documented framework on the new technologies to allow a rapid and simplified decision making process.
In its inaugural meeting in early June at the PEI in Langen, Germany,
the working group reviewed the current situation of RMMs in Europe and
defined a work plan.
The photo shows from left to right:
Dr Paul Newby, GlaxoSmithKline; Dr Christina Bruntner, Pall Life
Sciences; Dr Robert Johnson, Dialogue; Dr Thomas Lukow, Novartis Behring;
Elisabeth Jander, Pall Life Sciences; Mike Edgington, Director for
Regulatory Affairs (ECA); Dr Thomas Mikosch, Centocor; Dr Klaus Haberer,
Compliance Advice and Services in Microbiological; Dr Thomas Montag,
Paul-Ehrlich-Institut; Dr Sven Deutschmann, Roche Diagnostics; Dr Ulrich
Herber, Concept Heidelberg
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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To
find out more about the Working Group, a GMP Webinar was recorded on 7
July 2006 at the ECA Advisory Board Meeting. You can watch the recorded
Webinar for free. All you need is a fast internet connection, a sound card
in your PC and a Media Player like Windows Media Player or the RealPlayer.
Start Mike Edgington's presentation 
