Committee on Medicinal Products for Human Use

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The Committee for Medicinal Products ( Engl. : Committee for Medicinal Products for Human Use , official abbreviation: CHMP ) is a scientific committee of the European Medicines Agency . The CHMP prepares the evaluations of the European Medicines Agency and deals with the authorization and risk assessment of medicines that are used in humans and that are to be authorized across the EU. The CHMP is composed of representatives from the national drug authorities of the EU member states and the EU associated countries Iceland and Norway . It meets regularly on the premises of the European Medicines Agency. The CHMP Executive President is elected every three years.

Tasks of the committee

  • The CHMP assesses the quality , efficacy and safety of medicinal products for which pharmaceutical companies have applied for authorization . This is done on the basis of scientific data that the applicant provides as a comprehensive dossier . It contains descriptions of the manufacturing process and the drug analysis to prove the quality of the drug, and also the data and results of the toxicological and clinical studies to demonstrate the safety (when used as intended) and to demonstrate the pharmacological effectiveness.
  • Medicines that have been approved or for which approval is sought are assessed by the CHMP on the basis of their risk-benefit ratio . Here it is checked whether the desired effect is achieved without the side effects being too serious. A positive risk-benefit ratio is always an individual decision and above all depends on how serious the condition to be treated is.

Further tasks of the CHMP are:

As of July 2012, responsibility for pharmacovigilance matters was transferred to the newly formed Pharmacovigilance Risk Assessment Committee (PRAC ). Reports from pharmaceutical companies, clinics, doctors and pharmacists about adverse drug reactions ( ADRs , "side effects") are collected, processed and evaluated by national drug commissions and drug authorities. Until the establishment of the Pharmacovigilance Committee, the CHMP was involved in this process and, if necessary, made recommendations to the European Commission if a medicinal product was re-evaluated, if there were changes to the authorization, or if the authorization should be withdrawn or suspended.

Outline and organizational structure

In the Committee for Medicinal Products for Human Use, the 29 members, 27 from the EU Member States and 2 from the EEA-EFTA states Iceland and Norway, appoint a President and a Vice-President from among their number. The 29 members each have a deputy. The government of each Member State appoints one member and one alternate. Up to five additional members can be elected by the EU member states if additional specialist knowledge in special scientific areas is required. The members of the CHMP instruct the working groups, the scientific advisory groups and other committee groups of the committee with subject-specific work steps and evaluations. All groups of the Committee for Medicinal Products for Human Use work on behalf of the 29 CHMP members.

Executive presidents

  • 1995–2000: Jean-Michel Alexandre (France)
  • 2001–2007: Daniel Brasseur (Belgium)
  • 2007–2012: Eric Abadie (France)
  • 2012–2018: Tomas Salmonson (Sweden)
  • since 2018: Harald Enzmann (Germany)

Working groups of the committee

The Committee for Medicinal Products for Human Use hosts several working groups made up of members of the “European Expert List”. These are European scientists from certain scientific fields and belong to your working group for three years. The working groups advise the CHMP on specific questions from the respective specialist area. The CHMP also assigns subtasks from approval procedures, expert opinions and revisions of scientific guidance documents to the working groups.

Permanent working groups

The following permanent working groups are currently active for the Committee for Medicinal Products for Human Use:

  • Working group for biological medicines: Biologics Working Party (BWP). This working group deals with aspects of the quality and safety of biologically and biotechnologically manufactured medicines and works with the scientific committees of the European Medicines Agency. It helps with the evaluation of the dossiers of the authorization applications and, on request, advises on quality aspects of biological and biotechnological medicinal products and maintains contact with specialist groups, patient organizations, the pharmaceutical industry, the World Health Organization (WHO), biological control laboratories and pharmacopoeia producers on all matters relating to biological medicinal products . The BWP develops, sifts through and revises guidelines in its area of ​​expertise and organizes seminars on them or makes contributions to them. On behalf of the CHMP, she develops pronouncements on specific medicinal products or general statements in her specialist field. If necessary, the Working Group for Biological Medicines, at the request of the CHMP, sets up a rapid crisis group to deal with urgent issues relating to drug safety and the quality of biological medicinal products and to coordinate measures in the Member States.
  • Joint CHMP / CVMP Quality Working Party : Joint CHMP / CVMP Quality Working Party (QWP). It prepares advice for the Human Medicinal Products and Veterinary Medicines Committees relating to the quality of active ingredients authorized as both human and veterinary medicinal products. This interface working group provides a forum for the two committees CHMP and CVMP for common approaches to medicinal products that are used in both human and veterinary medicine and, at the request of the CHMP, takes part in the creation, review and revision of guidelines and provides scientific advice for questions about quality, about national differences in the assessment of quality. The working group maintains contact with similar committees in international health authorities and with European specialist groups, patient organizations and the pharmaceutical industry.
  • Working group for patients and consumers: Patients 'and Consumers' Working Party (PCWP). It represents the interests of patients in relation to medicines and is composed of representatives from the Secretariat of the European Medicines Agency, the scientific committees and representatives of patient organizations and consumer protection organizations of the EU Member States.
  • Safety Working Group: Safety Working Party (SWP). It draws up recommendations on questions of non-clinical safety and provides support in the evaluation of dossiers from authorization applications. It also evaluates non-clinical safety knowledge and organizes training measures for this. The working group cooperates with institutions of non-clinical safety in international health authorities and with thematically interested organizations.

Former permanent working groups

The Efficacy Working Party (EWP) was dissolved in September 2010 after several years of activity. She developed, reviewed and revised numerous guidelines for special therapeutic areas, methods and for the evaluation of clinical studies , supported the evaluation of dossiers of the approval applications, provided the CHMP with advice on the clinical part of drug development and was in contact with specialist groups, patient organizations and the pharmaceutical industry Industry. She cooperated in her work with the US FDA and the World Health Organization. Since then, the tasks of the EWP have been carried out by working groups that have been set up as required and work temporarily, each of which is correspondingly specialized.

The Pharmacovigilance Working Party (PhVWP) was adopted in July 2012 after 17 years of activity. She prepared recommendations for the CHMP on drug safety ( pharmacovigilance ). To do this, she collected data from the spontaneous reporting systems of the national drug authorities. She advised the national authorities on the recording and evaluation of drug-related risks ( risk management ) and established standards for pharmacovigilance procedures. She also cooperated with non-European drug authorities and the World Health Organization. With the establishment of the Pharmacovigilance Risk Assessment Committee (PRAC), the PhVWP's tasks were transferred to its responsibility.

Working groups meeting if necessary

The following working groups, which meet at times if necessary, are the

  • Working group for biosimilars: Similar Biological (Biosimilar) Medicinal Products Working Party (BMWP), which reviews and revises guidelines on the quality, effectiveness and safety of biosimilars . The so-called "biosimilars" are copycat drugs of an original drug that is produced biotechnologically. Unlike the classic, molecular structure-defined pharmaceuticals, these are not completely identical to the original active ingredient and therefore require more complex approval procedures and monitoring measures than the classic generics. For this reason, the term "biogenerics", which is occasionally used, is an insufficient characterization of these new generic drugs. The BMWP working group gives the CHMP scientific advice on questions relating to the general safety of biosimilars and their comparability with the original. It also cooperates with non-EU drug authorities, the World Health Organization, patient organizations, drug developers and specialist groups.
  • Vaccine Working Group: Vaccine Working Party (VWP). It develops, sifts through and revises guidelines for vaccines in cooperation with other suitable working groups and, upon request, gives scientific advice to the CHMP on questions about vaccine matters. It also supports the evaluation of dossiers from the approval applications and supports the implementation of epidemiological studies in cooperation with national health authorities. She maintains contact with committees on vaccines in international health authorities and with thematically interested European expert groups and the pharmaceutical industry and patient organizations and organizes training measures for vaccine manufacturers on questions of effectiveness, safety and quality in vaccine production. In the event of a drug safety incident involving vaccines, at the request of the CHMP, it sets up a rapid crisis group to deal with urgent questions about vaccine safety and the quality of vaccines and to coordinate measures in the Member States. The working group supports the introduction of the Vaccine Identification Standards Initiative (VISI) and coordinates pharmacovigilance measures for vaccines across Europe. She also oversees the development of new technologies for vaccine development (DNA-based vaccines, cancer vaccines, HIV vaccines) and the development of new adjuvants .
  • Pharmacokinetics Working Group: Pharmacokinetics Working Party . She is responsible for the creation and revision of guidelines dealing with the subject of pharmacokinetics of medicinal products and provides expert opinions on pharmacokinetic inquiries from the CHMP. These can be specific questions in connection with drugs that have already been approved, with new drugs in the approval process or as part of a scientific advice procedure. Most recently, one of her main tasks was the revision of the guidelines for investigating bioequivalence relevant to generic drug approval.
  • Blood Preparations Working Group: Blood Products Working Party (BPWP). It develops recommendations for the safety and effectiveness of blood preparations and creates, reviews and revises guidelines and summaries for assessing the effectiveness and safety of blood preparations. In addition, she supports the evaluation of approval application dossiers and evaluates the safety and usefulness of blood preparations as excipients in pharmaceuticals. Cooperation with international institutions, European specialist groups, patient organizations and the pharmaceutical industry is also one of their tasks. It also offers training measures on the effectiveness and safety of blood preparations.
  • Pharmacogenetics Working Group: Pharmacogenetics Working Party (PgWP). The pharmacogenetics working group organizes working meetings and information events for CHMP specialists and approval applicants to exchange information on pharmacogenetics and develops, sifts and revises guidelines for the processing and evaluation of pharmacogenetic topics in approval procedures. She supports the evaluation of dossiers of the approval applications, maintains contact with committees on pharmacogenetics in international health authorities and with thematically interested European experts and the pharmaceutical industry and takes part in the organization of training measures and specialist conferences on the subject of pharmacogenetics.
  • Working group for cell-based products: Cell-based Products Working Party (CPWP). It creates multidisciplinary recommendations on cell-based products and develops, sifts through and revises guidelines for special topics in the manufacture of cell-based products, especially on technical requirements for tissue engineering . The working group for cell-based products supports the provision of scientific advice and the evaluation of dossiers of the approval applications, maintains cooperation with international institutions, European expert groups, patient organizations and the pharmaceutical industry and organizes training measures on product safety and effectiveness. If a crisis occurs in connection with cell-based medicinal products, at the request of the CHMP it sets up a rapid crisis group to deal with urgent issues relating to medicinal product safety and the quality of cell-based products and to coordinate measures in the Member States.
  • Gene Therapy Working Party : Gene Therapy Working Party (GTWP). It ensures that the CHMP and its working groups are informed about specific issues relating to gene therapy drugs and provides the CHMP with scientific reports reflecting the public interest in gene therapy, advice on gene therapy issues and reports on specific gene therapy drugs. The gene therapy working group develops, sifts through and revises guidelines in cooperation with other suitable working groups and maintains contact with gene therapy committees in international health authorities and with European specialist groups, patient organizations and the pharmaceutical industry. Furthermore, she makes contributions to training measures and conferences that deal with gene therapy.

Scientific Advisory Groups to the Committee

Scientific advisory groups provide advice to the CHMP on how to evaluate individual medicinal products or therapies for specific diseases or syndromes . These advisory groups are made up of European scientists from the individual specialist areas and are appointed by the European Medicines Agency or the CHMP. Currently established scientific advisory groups are:

  • Scientific Advisory Group on Cardiovascular issues ( Scientific Advisory Group on Cardiovascular Issues , SAG-CVS)
  • Scientific Advisory Group on Anti-infectives ( Scientific Advisory Group on Anti-infectives , SAG-AI)
  • Scientific Advisory Group for Clinical Neuroscience ( Scientific Advisory Group on Clinical Neuroscience , SAG-CNS)
  • Scientific Advisory Group on Diabetes and Endocrinology ( Scientific Advisory Group on Diabetes / Endocrinology , SAG-D / E)
  • Scientific Advisory Group on Diagnostics ( Scientific Advisory Group on Diagnostics , SAG-D)
  • Scientific Advisory Group for HIV and viral diseases ( Scientific Advisory Group on HIV / Viral Diseases , SAG-HIV / Viral Diseases)
  • Scientific Advisory Group on Oncology ( Scientific Advisory Group on Oncology , SAG-O)
  • Scientific Advisory Group on Psychiatry ( Scientific Advisory Group on Psychiatry , SAG-P)

Other CHMP groups

The other CHMP groups will be asked for advice by the CHMP if their specific expertise is required. You will be assigned specific tasks relating to market approval, use cases and the drafting and assessment of control documents. Currently established CHMP groups are:

  • Healthcare Professionals Working Group : Healthcare Professionals' Working Group (HCPWG), which gives recommendations and suggestions on the cooperation between the European Medicines Agency and the CHMP and health care professionals.
  • Working group for the review of (invented) drug names: (Invented) Name Review Group (NRG). It checks the manufacturer-specific drug names (not the INN names ), whether they have ambiguous therapeutic or pharmacological meanings, whether they can lead to misunderstandings about the composition of the drug and whether they can lead to confusion because of a similarly named, already existing drug
  • Working group for the quality review of documents: Working Group on Quality Review of Documents (QRD) checks the package inserts for linguistic clarity, consistency and accuracy and for the accuracy of the translations from the original language. It promotes legibility of the information, checks compliance with EU regulations and contributes to the development of more understandable instructions for use.
  • Inspection service groups. The CHMP is supported by Inspection Services Groups (ISP) for Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).
  • Expert team for geriatrics : The Geriatric Expert Group (GEG) supports the work of the committee and the agency in matters relating to the safe and effective use of drugs, especially in the elderly.

Importance of the Committee on Health Care

The Committee for Medicinal Products for Human Use has become more and more important for the health system in Germany as a result of increased European cooperation, because many medicinal products on the German market are approved through a recommendation from the European Medicines Agency. The centralized procedure is mandatory for:

In addition, pharmaceutical companies can voluntarily apply for approval via the central approval procedure for medicinal products for human use that contain a new active ingredient or represent innovations in therapeutic, scientific or technical terms. One advantage is that such an approval process only has to be run through once and then applies to the entire economic area of ​​the EU.

See also

Web links

Individual evidence

  1. ↑ EMEA announces new CPMP Chairman and vice chairman , press release 2001.
  2. ↑ CHMP elects new chair and vice-chair at its first meeting , press release 2004.
  3. ^ Committee for Medicinal Products for Human Use-elects new chair and vice-chair , press release 2007.
  4. ↑ Dr Tomas Salmonson elected new chair of the Committee for Medicinal Products for Human Use (CHMP) , EMA News, 2012.
  5. ↑ EMA's Committee for Medicinal Products for Human Use (CHMP) elects new chair , press release 2018.
  6. ↑ CHMP: Working parties and other groups. EMA, 2011, accessed December 14, 2011 .
  7. ^ ZDF - Frontal21 : Hazardous Medicines , Dana Nowak, Astrid Randerath (broadcast on February 5, 2008).
  8. ↑ a b Europe - The portal of the European Union ( Memento of the original from March 14, 2008 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. Areas of activity - Legislation - Authorization and monitoring of medicines - European Medicines Agency .  @1@ 2Template: Webachiv / IABot / europa.eu