The follow up is a service aiming to maintain communication with the authorities and manage the issues that may arise during or after evaluation. ENC’s consultants will evaluate the request of the authorities, communicate the conclusions to the client, provide them strategic advices and determine the feasibility on undertaking unexpected roadblocks.
What is a data call?
The authorities may request additional information, new studies, new risk assessment calculation with other endpoints, risk assessment refinement, etc. The applicant may have to answer to the authorities within a specified period of time in order to continue the registration process.
How to react to a data call?
Replying to a data call will balance the applicant’s means (study ownership, letter of access, budget, etc. ) with the authority’s level of requirement and the registration objectives. There are 3 main reactions to such comments.
- To follow the relevant authority’s requirements.
- To wave the relevant authority’s requirements.
- To stick to the first submission statements.
Theses strategies involve different timeline, budget and chances of success.
The follow up may also be necessary after registration :
- if authorities add restrictions on an active substance, an update of the products authorisation is mandatory;
- if needed studies are pending, it is mandatory to provide them to the relevant authorities;
- after authorisation withdrawal following unexpected issue;
- if new data becomes available on the product, the active substance or the metabolite leading to changes in certificates of approval;
Thanks to its years of experience with Member States authorities, ENC understands the evaluator needs that lies behind the regulatory roadblocks.