Europe – Pilot phase for CHMP early contact with patient / consumer organisations

Patients and their representatives are involved in many activities at EMA and the added value of including their perspectives within committee evaluations has been well demonstrated.
They are currently involved at various timepoints during the medicines’ lifecycle, including CHMP evaluations. However, requests for patient input generally come at a later stage of the evaluation, often once major objections have been identified (e.g. expert meeting, oral explanation). Experience shows that late input may lead to missed opportunities to properly incorporate patient perspectives into the assessment process. Therefore in order to make current engagement practices more efficient and enhance timely participation, it is proposed to establish contact with relevant patient / consumer organisations at the start of new medicines assessment. This will enable patients to share aspects such as quality of life, treatment options and unmet medical needs so that the CHMP is well-aware of
all aspects from the beginning. This is also expected to facilitate further interactions with patients as the procedure progresses…