EU level data

The trade name under which the product is marketed for EMA

The International Nonproprietary Name (INN) of the active substance

The name of the marketing authorisation holder or applicant company

Option 1Option 2

The therapy area listed by the EMA

YesNo

Indicate whether the product has EU orphan designation

YesNo

Indicate whether the product is classed as an Advanced Therapy Medicinal Product (ATMP) according to the EMA

The date the Marketing Authorisation Application (MAA) was submitted to the EMA.

RegularAcceleratedConditional

Specify whether the product received standard, accelerated, or conditional approval from EMA.

YesNo

Indicate if the submission in question was a major change to an existing authorisation (Type II variation).

The total number of calendar days between all clock stops (calculated as days between each date of CHMP list of questions sent to HTD, and response date)

The date the Committee for Medicinal Products for Human Use (CHMP) issued its opinion.

The official date the European Commission granted marketing authorisation.

Option 1Option 2

The clinical development phase of the main trial supporting marketing authorisation (e.g., Phase II, III). If there are multiple pivotal trials, select the one in the most advanced phase. If unknown, please select 'Unknown/Not disclosed'

YesNo

Indicate whether patients in the pivotal trial were randomly assigned to treatment groups. If there are multiple pivotal trials, base your answer on the most methodologically robust trial.

Indicate the type of study design on the main trial supporting marketing authorisation, according to the drop-down options. If there are multiple pivotal trials, base your answer on the most methodologically robust trial. If unknown, please select 'Unknown/Not disclosed'

Indicate the type of control arm on the main trial supporting marketing authorisation, according to the drop-down options. If there are multiple pivotal trials, base your answer on the most methodologically robust trial. If unknown, please select 'Unknown/Not disclosed'

The total enrolled patient population across all pivotal studies supporting the application

The official start date of the JCA procedure, as per the JCA report timeline.

The date when the PICO (Population, Intervention, Comparator, Outcome) scope was finalised, as per the JCA report timeline

The date on which the Health Technology Developer (HTD) submitted the EU HTA dossier, as per the JCA report timeline. If multiple versions were submitted, please indicate the submission date of the final version that was accepted for assessment.

The date when the final Joint Clinical Assessment report was published and made publicly available.

Option 1Option 2

Indicate the country of the HTA body that served as the primary assessor in the JCA process.

Option 1Option 2

Indicate the country of the HTA body that served as the co-assessor in the JCA process.

Option 1Option 2

Indicate the countries of HTA bodies that participated as watchers (non-assessing observers) in the JCA process.

YesNo

Indicate whether the JCA assessment group had to revise the final PICO scope to align with changes to the product’s approved indication/label.

YesNoUnknown

Indicate whether the submitted EU HTA dossier was accepted as complete at the time of initial submission, or if the various submissions occurred.

YesNoUnknown

Indicate whether the updated V0.2 EU HTA dossier was accepted as complete following the Second Request for information or clarification.

The official date the JCA procedure was discontinued, if applicable.

YesNo

Indicate whether clinical experts/key opinion leaders were consulted by the assessors during the development of the JCA report.

YesNo

Indicate whether patient representatives (e.g., patient groups or individual patients) were consulted by the assessors during the development of the JCA report.

YesNoUnknown

Indicate whether a Joint Scientific Consultation (JSC) between the HTD and EU HTA bodies took place prior to the EU HTA dossier submission.

YesNoUnknown

Indicate whether a meeting was held between the JCA Subgroup and the Health Technology Developer (HTD) to provide further information for developing the assessment scope, as requested by the JCA Subgroup.

YesNoUnknown

Indicate whether an ‘assessment scope explanation meeting’ was held with the HTD after the final assessment scope (PICO) was shared.

The total number of distinct PICO frameworks (Population, Intervention, Comparator, Outcome) defined in the JCA report.

The number of comparators included in the PICO frameworks that were not within the EMA approved label (i.e., off-label use). Only count distinct off-label comparators; do not double-count off-label comparators that appear in various PICOs

The number of PICO frameworks for which the assessors accepted clinical evidence that relied on indirect comparisons.

The number of PICO frameworks for which no evidence was submitted (number of blank fields).