The Committee for Medicinal Products for Human Use (CHMP) is responsible for preparing the Agency's opinions on all questions concerning medicinal products for human use, in accordance with Regulation (EC) No 726/2004.
The CHMP plays a vital role in the marketing procedures for medicines in the European Union:
In the ‘Community’ or ‘centralised’ procedure, the CHMP is responsible for conducting the initial assessment of medicinal products for which a Community-wide marketing authorisation is sought. The CHMP is also responsible for several post-authorisation and maintenance activities, including the assessment of any modifications or extensions (‘variations’) to the existing marketing authorisation.
In the ‘mutual-recognition’ and ‘decentralised’ procedures, the CHMP arbitrates in cases where there is a disagreement between Member States concerning the marketing authorisation of a particular medicinal product (‘arbitration procedure’). The CHMP also acts in referral cases, initiated when there are concerns relating to the protection of public health or where other Community interests are at stake (‘Community referral procedure’).
Assessments conducted by the CHMP are based on purely scientific criteria and determine whether or not the products concerned meet the necessary quality, safety and efficacy requirements (in accordance with EU legislation, particularly Directive 2001/83/EC). These processes ensure that medicinal products have a positive risk-benefit balance in favour of patients/users of these products once they reach the marketplace.
Subsequent monitoring of the safety of authorised products is conducted through the EU’s network of national medicines agencies, in close cooperation with healthcare professionals and the pharmaceutical companies themselves. The CHMP plays an important role in this EU-wide ‘pharmacovigilance’ activity by closely monitoring reports of potential safety concerns (‘adverse drug reaction reports’, or ADRs) and, when necessary, making recommendations to the European Commission regarding changes to a product’s marketing authorisation or the product’s suspension/withdrawal from the market.
In cases where there is an urgent requirement to modify the authorisation of a medicinal product due to safety concerns, the CHMP can issue an ‘urgent safety restriction’ (USR) to inform healthcare professionals about changes as to how or in what circumstances the medication may be used.
The CHMP publishes a European Public Assessment Report (EPAR) for every centrally authorised product that is granted a marketing authorisation, setting out the scientific grounds for the Committee’s opinion in favour of granting the authorisation, plus a ‘summary of product characteristics’ (SPC), labelling and packaging requirements for the product, and details of the procedural steps taken during the assessment process. EPARs are published on the EMEA’s website, and are generally available in all official languages of the EU.
Scientific assessment work conducted by the CHMP is subject to an internal peer-review system to safeguard the accuracy and validity of opinions reached by the Committee. The EMEA’s integrated quality-management system ensures effective planning, operation and control of the CHMP’s processes and records.
Other important activities of the CHMP and its working parties include:
- the provision of assistance to companies researching and developing new medicines;
- the preparation of scientific and regulatory guidelines for the pharmaceuticals industry;
- cooperation with international partners on the harmonisation of regulatory requirements for medicines.