5. Assessment, opinion and EC decision
After positive validation, the assessment process starts.
EMA’s Committee for Medicinal Products for Human Use (CHMP) assesses applications submitted and recommends whether or not a medicine should be granted marketing authorisation (MA).
The CHMP members are each supported by a team of assessors in the national agencies, who have a range of expertise to evaluate various aspects of the medicine, such as its safety, quality and efficacy.
The CHMP also works with other EMA committees during the assessment. These include the:
- Committee for Advanced Therapies (CAT) leading the assessment of advanced therapy medicines (gene therapy, tissue engineering and cell-based medicines);
- Pharmacovigilance Risk Assessment Committee (PRAC) for aspects related to the medicine’s safety and risk management;
- Paediatric Committee (PDCO) for aspects related to the medicine’s use in children;
- Committee for Orphan Medicinal Products (COMP) for orphan-designated medicines.
The committees are composed of members from each of the EU Member States and from Iceland and Norway, plus co-opted members who provide additional expertise in particular scientific areas, who are nominated by the European Commission.
For each application for a new medicine, two committee members from different countries are appointed as rapporteur and co-rapporteur. They conduct the scientific evaluation independently from each other, each with an assessment team with assessors from their national agency and sometimes from other national agencies. In their assessment reports (ARs), each team presents its judgments of the medicine’s effects and its views on any uncertainties and limitations of the data. They also identify questions that will have to be answered by the applicant.
In addition to the rapporteur and co-rapporteur, the CHMP also appoints one or more peer reviewers from amongst the CHMP members. They review the two assessments and ensure that the scientific argumentation is sound, clear and robust.
All CHMP members, in discussion with colleagues and experts in their national agencies, also review the assessments from the rapporteurs, provide comments and identify additional questions to be addressed by the applicant. The initial assessment and the comments from peer reviewers and other committee members are then discussed during a plenary meeting of the CHMP.
As a result of the discussions and any information emerging during the assessment, either from additional experts or from clarifications provided by the applicant, the scientific arguments are refined. On this basis the CHMP develops and issues a scientific opinion on whether the medicine may be authorised or not. This is sent by the EMA to the European Commission, as the authorising body for all centrally authorised products, who takes a legally binding decision based on EMA's recommendation.
Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.
Commission decisions are published in the Community Register of medicines for human use. EMA publishes a European public assessment report (EPAR) for each medicine. When a new MAA is refused, EMA publishes a refusal EPAR, including a Q&A document. Publications are available within 67 days of receipt of the CHMP opinion.