publications
The MEB publishes a variety of documents:
- Annual reports
- Policy documents
For MEB meeting reports en CCR minutes, please go to
About MEB | News.
Publications about human medicines can be found via:
Human medicines | Publications.
Annual reports
You can download the
MEB’s annual report from the right-hand side of this page, in
the column ‘More information about
Publications’.
To get a free paper copy of an annual report, please fill
out the
contact form.
Policy documents
In the
Strategic Business Plan for 2009-2013 we identify and discuss
five strategic objectives. Our objectives for the next five years
are:
- Clear all assessment backlogs by 2011
- Continue to develop a scientifically robust, consistent and
transparent assessment system
- Assist and invest in efforts to strengthen the medicinal
product regulatory chain, both at national and European level
- Strengthen scientific underpinning
- Knowledge must be translated and disseminated.
The MEB had already taken the strategic decision to centralise
the entire organisation in Utrecht, as opposed to the five sites
spread across the Netherlands that it currently occupies.
Besides bringing together separate parts of the organisation, the
new location will also support the MEB’s ‘new working practices’.
Core concepts behind this new approach are teamwork, transparency,
responsiveness and openness to signals from society at large,
creativity and pleasure in work.
The new working practices will need to result in flexible and
teleworking initiatives in some areas. All this adds up to an
enormous challenge for the organisation and its staff in the coming
period. The strategic goals that have been set will help to
minimise the possible negative impact of these changes and the
associated relocation for our partners.
MEB’s Special-interest areas
This policy paper has been written with the
future in mind. In order to be able to plan the recruitment of
new clinical assessors more effectively, far-reaching decisions
need to be taken. There are two reasons for this. Firstly,
Europe (i.e., the EMeA) is requesting more and broader expertise
from each of the national regulatory authorities in relation to
European assessments. The EMA needs a number of active national
authorities that have clearly defined specialised expertise and
can guarantee high-quality input. The EMA therefore expects
these active national authorities to specialise. This requires a
broadening and deepening of expertise in current
special-interest areas. The MEB is aware that, in order to
achieve this, the number of special-interest areas must be
restricted. Secondly, there is a clear need for more clinical
assessors within the MEB. The workload is high, and now that the
MEB has chosen to be more transparent and open, even more will
be required of the clinical assessors. The crucial question is
what type of (extra) expertise the MEB will require. This does
not in any way mean that the quality of our current expertise is
insufficient, but the large number of assessments and the high
aims of the MEB result in (too) much being asked of (too) few
assessors. As a result, due to pressure of time, quality is
sacrificed. If the MEB is to maintain its position within
Europe, quality will have to be its driving force.
You can download the MEB's policy documents from the right-hand
side of this page, in the column ‘More information about
Publications’.