Committee on Safety of Medicines CSM

Committee on Safety of Medicines (CSM) Cornell Legal Library... 

By the time that an application for a product licence is ready, a certain amount of evidence on the safety of the drug will be available. In a review of product licence applications to the Committee on Safety of Medicines (CSMs), Rawlins and Jefferys presented data on the number of patients who were available for the assessment of safety and efficacy (Table 15.5). When it is considered that many of the patients included would have been in short-term clinical trials (up to 28 days), and that other trials would have been conducted on formulations and doses that were different from those recommended in the product licence application, then the relevant numbers are substantially reduced. 

Professor AC Frazer was appointed to succeed Sir Derrick but imfortimately he died shortly thereafter. During 1969, therefore. Professor EF Scowen succeeded Professor Frazer as the Chairman of the Committee. In June 1970, the membership of the Committee was revised to correspond with that of the then newly established (under section 4 of the Medicines Act 1968) Committee on Safety of Medicines (CSM). The full... 

The relevant advisory committees with a remit for medicines for human use established under the Medicines Act 1968 were the Committee on Safety of Medicines (CSM), set up in June 1970 (SI 1970/1257) under the Chairmanship of Professor EF Scowen and the British Pharmacopoeia Commission (BPC), also set up in June 1970 (SI 1970/1256) under the Chairmanship of Dr F Hartley (later Sir Frank Hartley). The Veterinary Products Committee (VPC), chaired by Professor CSG Grunsell (with a remit for... 

The Committee on Safety of Medicines (CSM) was established in 1970 under section 4 of the Medicines Act 1968. Its Terms of Reference are ... 

Great Britain s Committee on Safety of Medicines (CSM 1988) recommended that benzodiazepines should not be used alone to treat depression or anxiety associated with depression. Suicide may be precipitated in such patients. ... 

The FDA was not the only regulatory agency to show concern about Prozac-induced agitation, stimulation, and depression. In my Wesbecker testimony, I described how the British Committee on Safety of Medicines (CSM as cited in Breggin, 1994), prior to approval of Prozac, raised the... 

Advisory Committees have been established to perform certain duties under the Medicines Act. These currently comprise the Medicines Commission the Committee on Safety of Medicines (CSM) and its sub-committees dealing with chemistry, pharmacy and stcmdards, with pharmacovigilance, and with biologicals the British Pharmacopoeia Commission and the Advisory Board on the Registration of... 

Committee on Safety of Medicines (CSM) An independent body set up to give advice via the Medicines Control Agency (MCA), which administers the Medicines Act, to the licensing authorities under the Ministry of Health, competitive anatgonism See antagonism -pharmacodynamic. 

There has been recent concern from unpublished data in industry-sponsored trials of SSRIs in child and adolescent depression suggesting that these drugs may lead to an increased rate of suicidal ideation. This prompted a review of their use by the UK Committee on Safety of Medicines (CSM) in 2003, which raled that for major depressive disorder (MDD) in children and adolescents under the age of 18 ... 

The Committee on Safety of Medicines (CSM) in the UK has recently (2004) issued a warning of increased risk of cerebrovascular adverse events in elderly patients taking olanzapine and risperidone. The risk is especially raised in those with preexisting cerebrovascular disease. The mechanism, and risk with other antipsychotics, is imclear. 

The Licensing Authority is advised by expert committees, appointed by ministers, as advised by the Medicines Commission under Section 4 of the Medicines Act. These advisory committees consist of independent experts, such as hospital clinicians, general practitioners, pharmacists and clinical pharmacologists, not the staff of the DoH, and are appointed by ministers on the advice of the Medicines Commission. The relevant advisory committees since 1971 have been the Committee on Safety of Medicines (CSM), the Committee on Review of Medicines (CRM), the Committee on Dental and Surgical Materials (CDSM), the British Pharmacopoeia Commission (BPC) and the Veterinary Products Committee, which is administered through the Ministry of Agriculture, Food and Fisheries (MAFF). 

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