EUnetHTA21 - Publication (draft) D5.4 deliverable

Scenario 1 is planned for the assessment of new chemical entities (NCE) in regular EMA assessment procedures. The JCA procedure will start 2 months after submission of the regulatory dossier to EMA and will be finalised with the endorsement of the JCA report by the HTA CG no later than 30 days after the EC decision for approval.
At the point of submission of the regulatory submission dossier (the Common Technical Document, CTD) to EMA, the information on the drug to be assessed and on the claimed indication is available and shall be transmitted to the HTA CG secretariat. In addition, the Clinical Overview (Section 2.5 of the CTD) shall be provided by EMA to enable a better understanding of the claimed indication.

Scenario 2 could be used for the JCA of new indications of already approved drugs (Type II variations) and in cases of accelerated approval. An earlier start of the JCA process is recommended in these cases because EMA’s standard timelines for these processes are shorter than for the regular assessment of NCEs.
In scenario 2 the JCA procedure starts at the point of submission of the regulatory dossier to EMA. Assuming the currently planned durations of the JCA steps, this would result in a JCA report being available before EC approval in a standard EMA procedure. However, it is assumed that in the cases included in scenario 2 the EMA procedure might be shorter than the assumed standard procedure.

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