Consultation with GMO-CA during the Marketing application
Overall, the assessment of a new medicine is completed within 210 active
review days. This active evaluation time is the time spent by EMA
experts to evaluate the evidence provided by the applicant in support of
marketing authorisation applications. This time is interrupted by one or
two ‘clock-stops’ during which the applicant prepares the answers to any
questions raised by the CAT. The duration of a clock-stop depends on how
long the applicant thinks it will take to respond.
For each new medicine, two CAT members− known as rapporteur and
co-rapporteur − from different countries are appointed to lead the
assessment.
Experts with specialised scientific knowledge are often consulted during
the evaluation to enrich the scientific discussion and for medicines
containing a GMO, the GMO Competent authorities responsible for
environmental risks in each Member State must be consulted.
This consultation is handled, in the same way that all CAT members
contribute actively to the evaluation process, by reviewing the
assessments made by the rapporteurs, providing comments and identifying
additional questions to be addressed by the applicant.
As a general principle, the consultation with the environmental
authorities, shown in figure 1, only takes place during the 1st phase of
the marketing authorisation applications evaluation and the focus is in
advising the CAT on the best measures to prevent dissemination into the
environment.
Although the ERA is reviewed together with the rest of the dossier by
EMA, the ERA must also be presented as a self-standing document to allow
distribution to Environmental Competent Authorities as part of the
necessary consultation. All parties involved in the evaluation of an
application are required to respect confidentiality in relation to all
data contained in the dossier and assessment reports relating to the
product. The information will only be made available to the public after
the approval of the marketing authorisation as part of the European
Public Assessment Report.
In addition, it should be pointed that the consultation procedure must
be conducted in accordance with the framework and the deadlines of the
medicine evaluation procedure (e.g. deadlines and consultation
procedures under GMO framework are not applicable).
It is important that developers identify prior to dossier submission if
there is any need for control measures during reconstitution, handling
and administration, personal protective equipment, decontamination or
cleaning measures after administration or in case of accidental
spilling, elimination of left-overs or waste management, recommendations
to patients to prevent dissemination or warnings regarding donation of
blood, cells tissues or organs including realistic durations for these
precautions. The common application forms for ERAs and good practice
documents provide a very comprehensive guidance to build the
environmental risk assessment.
While it is a regulatory requirement to assess thoroughly all the
potential risks and define measures to minimise any potential for
exposure, the EMA also expects that recommendations and warnings are
proportionate to the actual hazards posed and recommends avoiding
overcomplicated procedures or unnecessary protective equipment. At the
same time, even when the ERA may be more straightforward, it is also
expected that the justifications to reach certain conclusion must be
provided and the absence of warnings discussed.