The Agency gives scientific advice by »answering questions posed by companies based on the documentation provided by the applicant in the light of the current scientific knowledge«. So, based on our experience, the most critical step is defining the right questions to adequately support your marketing authorisation procedure. We all know that scientific advice is not legally binding. It is therefore even more important to be excellently prepared for the discussion with scientific expertise and good argumentation to achieve the best benefit possible and the highest reliability for the future approval process.
Our service depends on your own plan. Are you seeking for protocol assistance only? Or would you like to discuss your clinical development plan at a very early stage? Is national advice your primary intention or are you even planning a centralised procedure? Or are you already in the post-authorisation phase? Or looking for parallel advice from EMA and FDA?
Health technology assessment bodies are gaining greater influence as novel medicines are becoming accessible to patients, mainly due to increased pressure on healthcare budgets. The relative effectiveness of medicines, their usefulness to the healthcare system and the financial cost of medicines in accordance with national legislation become more and more important issues to avoid that authorised new medicines fail to be reimbursed. Thus, early cooperation between the applicant, medicines regulators and HTA bodies has the potential to increase the probability of success.
Our team of experienced scientists at SocraTec C&S supports you at any stage of medicinal product development.
“European Medicines Agency Guidance for applicants seeking scientific advice and protocol assistance”, EMA/691788/2010 Rev. 7