EMA plots earlier engagement with patient groups

Regulatory NewsRegulatory News | 19 February 2021 |  By 

The European Medicines Agency’s (EMA) on Friday announced it will pilot an early engagement program to bring patient and consumer groups to the table with its human medicines committee earlier in the evaluation process.
In its proposal for the pilot, EMA says there are “missed opportunities” for its Committee for Medicinal Products for Human Use (CHMP) to incorporate patient perspectives into its reviews, as patient input is typically sought late in the process and often after major objections have been identified. Left unresolved, major objections to a medicine can prevent a medicine from being authorized.
“In order to make current engagement practices more efficient and enhance timely participation, it is proposed to establish contact with relevant patient/consumer organizations at the start of new medicines assessment,” EMA writes.
Doing so, the agency says, will enable it to gather information about quality of life, treatment options and unmet medical needs from patients and ensure that CHMP is “well-aware” of those issues at the start of its reviews.
EMA says the pilot will cover marketing authorization applications (MAAs) for all new active substances with orphan status that are about to begin the review procedure. Once a list of the MAAs is drawn up and published to its website, EMA says it will begin to contact the relevant patient organizations that represent the therapeutic area for each application. Once contacted, the groups will have 3-4 weeks to respond with their input.
The agency adds that the patient groups will generally be those already part of its network of eligible EU patient and consumer organizations.
In the template for contacting patient organizations, EMA asks respondents to detail “any aspects that are of particular importance to patients/carers, such as quality of life, standard treatments and how acceptable they are, therapeutic/unmet medical needs, what benefits they would hope for in new medicines as well as what level of side effects they would consider acceptable.”
The template also asks if there are large differences between groups of patients and carers about any of those issues and to detail any aspects of a condition or treatment that patients feel are not well understood or sufficiently considered.
EMA says it will not share documents or confidential information from the MAAs with patient groups but adds that it will keep them up to date throughout the procedure and reach out when there are further opportunities for engagement.
The pilot is set to run for at least one year, with an interim analysis expected at the six-month mark.


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