Committee for Medicinal Products for Human Use

The Committee for Medicinal Products for Human Use, generally known as the CHMP, is the European Medicines Agency's principal scientific committee for medicines intended for people. It evaluates the quality, safety and efficacy of human medicinal products and determines whether the available evidence supports a positive benefit–risk balance. Its conclusions are expressed as scientific opinions rather than final marketing-authorisation decisions: the European Commission normally uses those opinions as the basis for legally binding authorisations, refusals, suspensions or withdrawals applying across the European Union. The committee originated in the European regulatory framework of the 1970s as the Committee for Proprietary Medicinal Products, or CPMP. Its initial role was linked to a multi-state system based on mutual recognition of national marketing authorisations. Where one member state refused to recognise another state's licensing decision, the issue could be referred to the CPMP for an opinion. This early procedure was advisory and was later simplified before the mutual recognition procedure became the principal framework in 1995. The establishment of the European Medicines Agency, originally called the European Agency for the Evaluation of Medicinal Products, changed the committee's institutional setting. When the agency began operating in 1995, the CPMP became part of the agency's structure and took responsibility for scientific assessments under the centralised procedure. That procedure allows an applicant to submit one application for a medicine that, after a favourable European Commission decision, can receive a marketing authorisation valid throughout the European Union. In 2004, Regulation (EC) No. 726/2004 formally replaced the CPMP with the CHMP and defined its role within the modern European medicines system. The CHMP assesses initial applications, extensions and variations to existing authorisations, and products referred to the EMA when a harmonised European position is needed. The standard active evaluation period for a centralised application is 210 days, although the timetable can be extended by clock stops while the applicant responds to questions or supplies additional information. A negative opinion may be followed by a request for re-examination, which can add up to 120 days. The European Commission generally has 67 days after a CHMP opinion to adopt its decision. The centralised procedure is compulsory for several categories, including biotechnology-derived medicines, orphan medicines and certain medicines for major diseases such as cancer, AIDS, diabetes and neurodegenerative disorders when the applicable legal conditions are met. It can also be used for other products containing a new active substance, offering significant therapeutic or scientific innovation, or considered suitable for an EU-wide authorisation in the interests of patients. The committee also has an important post-authorisation function. Since 2012, it has considered safety recommendations from the Pharmacovigilance Risk Assessment Committee. When new evidence changes the understanding of a medicine's risks, the CHMP may recommend amendments to the marketing authorisation, restrictions on use, suspension or withdrawal. The committee therefore contributes both to initial access to medicines and to continuing regulatory oversight. Membership consists of one representative and one alternate appointed by each European Union member state, together with representatives from Iceland, Norway and Liechtenstein. Up to five additional experts may be co-opted when specialised knowledge is needed. EEA-EFTA representatives participate in scientific discussions but do not vote on the adoption of opinions. The CHMP meets monthly at the EMA. Although its opinions are formally advisory, the European Commission has historically followed them in nearly all recorded cases, giving the committee substantial practical influence over the availability of medicines across Europe.

The institutional history of the CHMP begins with the European Community's attempt to coordinate national medicines regulation. Before a European-level system existed, pharmaceutical companies generally sought separate national authorisations, while member states retained responsibility for deciding whether products could be marketed in their territories. The Second Council Directive 75/319/EEC, adopted on 20 May 1975 and brought into effect on 20 November 1977, established the Committee for Proprietary Medicinal Products. The CPMP was created to support a multi-state licensing framework based on mutual recognition of national decisions. In its original configuration, the committee performed an arbitration function. A company that had obtained an authorisation in one member state could seek recognition in other states. If another state refused to recognise the original decision, the matter could be referred to the CPMP. The committee examined the scientific and regulatory dispute and issued an opinion. That opinion was advisory rather than directly binding, but it provided a mechanism for resolving disagreements and encouraging greater consistency between national authorities. The first version of the arrangement was commonly associated with a CPMP procedure that operated from 1976 to 1985. It was simplified into a multi-state licensing procedure for the period from 1986 to 1995. In 1995, the mutual recognition procedure replaced that earlier framework. These changes reflected the gradual development of a more integrated European medicines market while preserving a role for national authorities in many licensing decisions. A major institutional transition occurred with the creation of the European Agency for the Evaluation of Medicinal Products under Regulation (EEC) No. 2309/93. The agency, later renamed the European Medicines Agency, began operating in 1995. The same European regulatory development introduced the centralised procedure, under which a single application could be scientifically evaluated at European level and lead to a marketing authorisation covering the member states. The CPMP was incorporated into the agency and became the principal committee for scientific assessments of human medicines submitted through that route. The centralised procedure substantially expanded the committee's importance. Instead of serving mainly as an arbitration body between national authorities, it became responsible for reviewing complete development dossiers, examining manufacturing and quality information, assessing clinical and non-clinical evidence, and weighing therapeutic benefits against identified and potential risks. A favourable opinion is sent to the European Commission, which makes the final legally binding decision. The Commission may grant, refuse, suspend or revoke an authorisation, while the scientific reasoning is supplied primarily through the committee's assessment. Regulation (EC) No. 726/2004, adopted on 31 March 2004, reorganised the European medicines framework and formally established the Committee for Medicinal Products for Human Use as the successor to the CPMP. The change of name reflected the committee's broader and more clearly defined function within the EMA. The CHMP became responsible not only for new applications but also for extensions, variations and referral procedures involving already authorised products. The committee's remit has continued beyond initial licensing. Since the creation of the Pharmacovigilance Risk Assessment Committee in 2012, the CHMP has considered that committee's recommendations on the safety of medicines already on the market. It can then recommend regulatory changes, including new restrictions, amendments to product information, suspension or withdrawal. This gives the CHMP a continuing role across the life cycle of a medicine rather than limiting its work to the moment of first authorisation. The CHMP is composed of national representatives: each European Union member state appoints one member and one alternate after consultation with the EMA Management Board. Iceland, Norway and Liechtenstein also appoint members and alternates as EEA-EFTA participants. The committee may co-opt up to five additional experts when a particular scientific field requires specialised knowledge. EEA-EFTA members take part in scientific deliberations but do not vote on the adoption of opinions, and their positions can be recorded separately in formal documents. The committee meets monthly at the EMA. Its evaluations normally follow a 210-day active timetable, excluding pauses while applicants answer questions or submit additional evidence. Applicants can seek re-examination of a negative opinion. While the CHMP is formally advisory, the European Commission has followed its opinions in nearly all recorded cases, making it one of the most consequential scientific bodies in the European medicines authorisation system.

• 2012

  Expanded pharmacovigilance role

  [1]Committee for Medicinal Products for Human Useen.wikipedia.org

  Following the establishment of the Pharmacovigilance Risk Assessment Committee, the CHMP began considering its recommendations on the safety of medicines already on the market.

• 2004

  CHMP formally established

  [1]Committee for Medicinal Products for Human Useen.wikipedia.org

  Regulation (EC) No. 726/2004 formally established the Committee for Medicinal Products for Human Use as the successor to the CPMP.

• 1995

  Integration into the European medicines agency

  [1]Committee for Medicinal Products for Human Useen.wikipedia.org

  The European Agency for the Evaluation of Medicinal Products began operating, the centralised procedure was introduced, and the CPMP became part of the agency's scientific structure.

• 1986

  Multi-state licensing procedure

  [1]Committee for Medicinal Products for Human Useen.wikipedia.org

  The earlier CPMP procedure was simplified into a multi-state licensing procedure that remained in use until the mutual recognition system was introduced.

• 1977

  Directive enters into effect

  [1]Committee for Medicinal Products for Human Useen.wikipedia.org

  The directive creating the CPMP framework became effective, giving the committee its initial arbitration role in disputes over recognition of national licensing decisions.

• 1976

  Initial CPMP procedure begins

  [1]Committee for Medicinal Products for Human Useen.wikipedia.org

  The first version of the CPMP procedure operated as part of the emerging European system for multi-state medicines licensing.

• 1975

  Creation of the CPMP framework

  [1]Committee for Medicinal Products for Human Useen.wikipedia.org

  Directive 75/319/EEC established the legal basis for the Committee for Proprietary Medicinal Products and a European multi-state approach to recognising national marketing authorisations.

A European Union scientific medicines-assessment body operating within the European Medicines Agency. It is not a pharmaceutical manufacturer or a commercial product brand; its role is to provide expert, evidence-based opinions that support European Commission decisions on human medicines.

• Regulatory assessment · 1995

  Centralised-procedure scientific assessment

  The CHMP evaluates applications for medicines seeking a European Union-wide marketing authorisation. Its review covers pharmaceutical quality, manufacturing, non-clinical evidence, clinical evidence and the overall balance between benefits and risks. The resulting opinion is transmitted to the European Commission, which makes the legally binding authorisation decision.

• Regulatory assessment · 1995

  Post-authorisation assessment

  The committee evaluates variations, extensions and other changes to medicines that already hold centralised authorisations. These assessments can concern new indications, manufacturing changes, updated evidence or revisions to the terms and conditions of an authorisation.

• Regulatory harmonisation · 1995

  Referral procedure opinion

  When a medicine authorised at national level requires a harmonised European position, the matter may be referred to the EMA. The CHMP reviews the scientific and regulatory issues and issues an opinion intended to support a consistent position across participating European markets.

• Medicine safety oversight · 2012

  Pharmacovigilance-related recommendation

  The CHMP considers safety recommendations from the Pharmacovigilance Risk Assessment Committee and may recommend changes to product information, restrictions, suspension or withdrawal when the benefit–risk balance of a marketed medicine requires regulatory action.

• 2004

  Replacement of the CPMP by the CHMPStrategy

  Background

  The European Union revised its pharmaceutical legislation and reorganised the institutional framework governing centrally authorised medicines.

  Action taken

  Regulation (EC) No. 726/2004 formally established the CHMP as the successor to the CPMP.

  Aftermath

  The present committee identity and its broader remit for human-medicine assessments, variations and referrals were formalised.

  Source

• 1995

  Integration with the centralised authorisation procedureStrategy

  Background

  The new European medicines agency introduced a system in which one application could support an authorisation valid throughout the European Union.

  Action taken

  The CPMP was incorporated into the agency and assigned responsibility for scientific evaluations under the centralised procedure.

  Aftermath

  The committee's role expanded from arbitration between national authorities to full scientific assessment of applications for European-wide authorisations.

  Source

• 1975

  Adoption of the European multi-state medicines frameworkStrategy

  Background

  European medicines authorisations were principally handled by national authorities, creating a need for mechanisms to recognise decisions across borders and resolve disagreements.

  Action taken

  Directive 75/319/EEC created the CPMP and assigned it an advisory arbitration role in disputes concerning recognition of national marketing authorisations.

  Aftermath

  The framework provided an early institutional foundation for later mutual-recognition and centralised European medicines procedures.

  Source

1. 1Committee for Medicinal Products for Human Useen.wikipedia.org