Glossary of MHRA terms - C

C

---

CA
Competent Authority. This is a body which has the authority to act on behalf of the government of an EU Member State to ensure that the requirements of the Directives are carried out in that Member State.

CAPLA/CANDA
Computer Assisted Product Licence Application/ Computer Assisted New Drug Application. This is a means of submitting product licence applications by computer.

CAS
Central Alerting System.

CCRA
Clinical Contract Research Association

CD
A controlled drug.

CDRH
The Centre for Devices and Radiological Health is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products. Radiation-emitting products regulated by the CDRH include medical ultrasound and x-ray machines.

CE(O)
Chief Executive (Officer).

CE MARK
European mark of approval for medical devices.

CEN
Comité Européen de Normalisation (European Committee for Standardization).

CENELEC
Comité Européen de Normalisation Electrotechnique (European Committee for Electrotechnical Standardization).

Centralised procedure
This is part of the EU licensing system resulting in a single European MA and direct access to a single community market. The Rapporteur/ Co-rapporteur is responsible for the pre-authorisation assessment and the Rapporteur continues with post-authorisation evaluation and pharmacovigilance. (See also Mutual recognition ).

CEP
Central Enquiry Point. This is the first contact point for callers to the MHRA who do not know who they wish to speak to.

CFC
Chlorofluorocarbons. These are used as propellants in aerosols and are currently being phased out in inhalers.

CHAI
Commission for Healthcare Audit and Inspection. 

CHI
Commission for Health Improvement. This is a body which aims to improve healthcare for patients by raising standards in clinical care. See also: Healthcare Commission.

CMD(h)
Coordination Group for Mutual Recognition and Decentralised procedures (human).

CHM
Commission on Human Medicines. Formed by the amalgamation of the Medicines Commission and the Committee on the Safety of Medicines.

CHMP
Committee on Human Medicinal Products. This is a European Committee based at the EMEA.

CIOMS
Council for International Organizations of Medical Sciences. A WHO authority.

CJD
Creutzfeldt-Jakob Disease.

CIOMS
Council for International Organizations of Medical Sciences (WHO spelling) - works under the WHO umbrella.

CMP
Coalition for Medical Progress.

CMS
Concerned Member State. This is a member state involved with the licensing process but not the state doing the assessment.

CPS
Chemistry Pharmacy and Standards Subcommittee.

Concertation procedure
Obsolete term. See: Centralised Procedure.

Co-rapporteur
See: Rapporteur. Works with a Rapporteur to provide expert evaluation for a centralised procedure.

CPMP
Committee for Proprietary Medicinal Products. See: CHMP

CPS
Chemistry Pharmacy and Standards Sub-Committee.

CR
Computed radiology.

CRM
Committee on Review of Medicines. This Committee has ceased functioning.

CSCI
Commission of Social Care Inspection. This body regulates, inspects and reviews all adult social care services in the public, private and voluntary sectors in England.

CSD
Committee on the Safety of Devices. This is an external group responsible for giving advice on a wide range of device related initiatives.

CSM
Obsolete acronym. See: CHM.

CT
Computed tomography.

CTA
Clinical trial authorisation.

CTC
Clinical Trials Certificate. This is a certificate issued to allow clinical trials with a new drug to be conducted.

CTD
Clinical Trials Directive.
Common Technical Document.

CVMP
Committee for Veterinary Medicinal Products.