EMA published a report on the pilot on its parallel regulatory-health technology assessment scientific advice with a Best Practice Guide.
Since 2010, the EMA has initiated a pilot project of parallel HTA-regulatory scientific advice, with the participation of several HTA bodies that allows developers to receive simultaneous feedback from both regulators and national HTA bodies on their development plans for new medicines.
Further input on this pilot procedure was received during the EMA HTA workshop on parallel scientific advice in November 2013.
Scope of the parallel Scientific Advice:
Applicants may request advice on any medicinal products for use in humans, irrespective of the medicinal product’s eligibility for the centralised procedure, and at any stage of the product lifecycle.
Pre-notification phase (early engagement): early informal discussions with HTA bodies and EMA, describing their aims for the procedure, the medicine, timeframe and which HTA bodies will participate. Following confirmation of the date of the face to face meeting, applicants then contact HTABs swiftly to request their availability for the desired face to face meeting date. HTABs may also choose to participate as observers. Alternatively, EMA may make initial contact with HTA bodies to request availability. EMA will facilitate administrative and logistical coordination.
Pre-submission phase: includes a TC with HTA bodies to discuss the scope, wording and clarity of the questions, and whether the material provided is sufficient to answer the questions posed. Applicants circulate their own documents throughout the procedure directly to all participants.
Evaluation phase: a face-to-face meeting between all stakeholders, lasting a maximum of 4 hours.
Advice: not legally binding. The meeting minutes are circulated by the applicant within 5 working days after the evaluation meeting. The CHMP provides regulatory scientific advice in a letter which the sponsor may share with participating HTA bodies. HTA bodies (HTABs) will provide their written answers directly to the applicant within 15 working days from the face-to-face meeting or in the format preferred by the respective HTA body.
Key Highlights from the pilot (from July 2010 to December 2015):
63 parallel scientific advice procedures completed
4 of them were parallel SEED* procedures
*SEED= Shaping European Early Dialogue
59 of them were parallel nonSEED procedures
• TAs and product types:
PROCEDURES PER ATC
• Orphan drugs: total of 9 orphan drugs procedures, and of these, 3 requested advice on significant benefit
• Paediatrics: 1 single procedure was for paediatric use only, however 14% (n=9 out of 63) had Paediatric Committee involvement.
Following the completion of the pilot, parallel scientific advice with HTA bodies and other relevant stakeholders is now routinely offered as part of the Agency’s scientific advice activities (14 procedures are already registered in 2016).