CRED ERP 25

07/07/2025

● The standard CP comprises two main assessment phases which take place over a 210-day period (excluding clock-stops where the applicant answers assessment questions). ● The primary evaluation takes place from day 1 to day 120, at which point the applicant will need to respond to the list of questions posed by the CHMP (you have up to three months to respond). ● Following on from this is the secondary evaluation from day 120 to day 180 wherein a second round of questions follows (list of outstanding issues). ● Following the month clock-stop for the company to respond to day 180 questions, the final evaluation and CHMP opinion is issued at day 210, which is followed by a further phase of 67 days – the decision making phase at the end of which the European Commission issues its decision on the grant of the MA. ● Although these are the main steps, there are a few possible additional steps that might occur such as routine or triggered requests for good manufacturing practice (GMP), good laboratory practice (GLP), good clinical practice (GCP) inspections, consultation with scientific advisory groups (SAGs) or ad hoc expert groups, and other committees and working parties. A number of committees are therefore involved during the CP. There is also the possibility that the company may be asked to give an Oral Explanation at the CHMP.

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ORPHAN DRUG DESIGNATION

● About 36 million people living in the European Union (EU) suffer from a rare disease. The European

Medicines Agency (EMA) plays a central role in facilitating the development and authorisation of

medicines for rare diseases, which are termed 'orphan medicines' in the medical world.

● Applications for orphan designation are examined by the EMA's Committee for Orphan Medicinal

Products (COMP), using the network of experts that the Committee has built up.

● The evaluation process takes a maximum of 90 days from validation. EMA sends the COMP opinion to

the European Commission, which is responsible for granting the orphan designation.[3]

● The European Medicines Agency (EMA) assesses whether a medicine continues to meet the criteria for

maintaining its orphan status in parallel with assessing an application for marketing authorisation.

● Sponsors may also need to submit an evaluation of orphan similarity. This enables EMA to determine

whether the medicine can maintain its status as an orphan medicine and benefit from market

exclusivity.[3]

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