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.