Scientific Committee on Medicinal

DEHP assessment (205) has shown no risk reduction measures are necessary for the general population, but measures could be taken to reduce risk of exposure in children s toys (although DEHP is not used in toys intended to be put in the mouth) and medical devices (against the opinion of the EU s Scientific Committee on Medicinal Products and Medical Devices). Prior to these results some formulators had already begun to change from DEHP to DINP (119). 

The Department of Health is reported to be searching for diethylhexyl phthalate-free products for the National Health Service following international concern over possible health effects from exposure to the plasticiser. The EU Scientific Committee on Medicinal Products Medical Devices has made no recommendation that hospitals should take any precautionary measures to reduce exposures of groups of patients considered to be at risk although Health Canada and the FDA have issued precautionary assessments. 

UK,DEPT.OF HEALTH UK,NATIONAL HEALTH SERVICE EU,SCIENTIFIC COMMITTEE ON MEDICINAL PRODUCTS MEDICAL DEVICES HEALTH CANADA US,FEDERAL DRUGS ADMINISTRATION... 

European Commission (1998). Opinion on toxicological data on colouring agents for medicinal products amaranth, adopted by the Scientific Committee on Medicinal Products and Medical Devices on 21 October 1998. http //europa.eu.int/comm/health/ph risk/ committees/scmp/scmp en.htm (accessed 30 June 2005). 

DG XXIV Scientific Committee on medicinal products and medical devices... 

It was decided in August 1997 that DG XXIV Consumer Policy and Consumer Health, now renamed the Health Directorate in 1999 Protection, should set up a number of eight new advisory committees, including a Scientific Committee on Medicinal Products and Medical Devices. These committees are expected to meet 10 times per year, and the Committee on Medicinal Products and Medical Devices met for the first time on 10-14 November 1997. The European Drug and Device Report stated Feathers... 

DC XXIV Scientific Committee on Medicinal Products and Medical Devices... 

The draft decision is then sent to the Standing Committee on Medicinal Products or the Standing Committee on Veterinary Products for their opinions. Should there be detailed opposition from a member state to the draft decision, the standing committee can refer it back to the CPMP if the opposition is scientific. If the matter is nonscientific, the council decision is made on the basis of a qualified majority, where each member state has a different number of votes depending on its size and importance and the majority of votes must be in favor. If within a further 30 days there is no opposition, the draft decision is forwarded to the Commission secretariat-general for adoption, enabling the Commissioner for enterprise and the information society to issue the final decision which is published in the Official Journal of the European Communities. 

A survey in 2000, carried out in Los Angeles by a group at the University of Southern California School of Medicine, found a link with bladder cancer. It involved 1541 people with this condition and they were compared to 897 people who were not so afflicted. Adjustments were made to take into account smokers, who are liable to be more at risk of this disease in any case, and it found that those who used permanent hair dyes every month had a slightly higher risk of bladder cancer, especially if they had used hair dyes continuously for 15 or more years. Hairdressers had an even higher risk. This revelation prompted the Scientific Committee on Cosmetic Products and Non-Food Products ofthe EU (SCCNFP) to issue a discussion paper in February 2002. This was followed in December that year by a requirement that manufacturers must submit by July 2005 all their data on hair dyes together with studies to assess their safety in terms of cancer and toxicity. The outcome of this has yet to be published, but it will take the form of an approved list of hair dyes which will be issued in 2007. 

Food and Nutrition Board set a tolerable upper level for adults of 100 mg per day (Institute of Medicine, 1998) the European Union (Scientific Committee on Food, 2000) set 25 mg per day. 

Scientific Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine, National Academy Press, Washington, DC, 1997-1999. 

DG XXIV Scientific committee on medical products and medicinal devices... 

As intended, the Directive is being adapted by MS and CA in line with scientific and technical progress, the removal of technical barriers to trade. Should any amendments become necessary, this will be through the existing Standing Committee on Medicinal Products for Human Use , which the Commission must consult if the Commission disagrees with this Committee the matters would be referred to the Council. 

The European Union (EU) ageneies responsible for the scientific evaluation of the safety of feed additives and veterinary medicinal products are, respectively, the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA). The EFSA is advised on scientific aspects of feed additives, including the safety of target species, consumers, users and the environment, by the Panel on Additives and Products or Substances Used in Animal Feed (FEEDAP). Some of the older evaluations of feed additive uses of coccidiostats under Directive 70/524/EEC were performed by the Scientific Committee on Animal Nutrition (SCAN), which reported to the European Commission prior to the establishment of EFSA. The Committee for Medicinal Products for Veterinary Use (CVMP) advises the EMA on scientific aspects of veterinary medicines. The distinction between medicinal and feed additive uses is not always clear, as some uses to prevent coccidiosis are considered to be medicinal e.g. use of lasalocid in poultry). 

The Scientific Committees are key to the functioning of the agency. They are the scientific decision-making component responsible for delivering opinions and advice on any issue relating to medicines. There are currently five committees, each focussed on different areas ... 

The latter session included government perspectives from the EPA OPPTS, the EPA Office of Research and Development, the EPA Office of Children s Health Protection, the OECD, the EMEA and the Committee for Medicinal Products for Human Use (CHMP), in addition to industry perspectives reflecting both the chemical and pharmaceutical industries.19 The NIEHS/NIOSH workshop was limited to 23 invited participants. A limited number of background scientific presentations were given, and the emphasis was on break-out group sessions in which a series of predetermined questions were raised and key points were captured by rapporteurs.17... 

Within the frame of the EMEA, members of the CPMP and CVMP act independently of their nominating member state. The scientific committees are aided by a network of about 2300 European experts, nominated by the appropriate national authorities of the member states on the basis of proven experienee in the assessment of medicinal products. Experts may serve on working parties or expert groups of the CPMP or CVMP. 

Hughes, W.F. Importance of mustard burns of the eye as judged by WW I statistics and recent accidents. IN National Research Council, Division of Medical Sciences, Committee on Treatment of Gas Casualties. Fasciculus on Chemical Warfare Medicine, Volume I Eye. Prepared for the Committee on Medical Research of the Office of Scientific Research and Development. 

The use of vertebrates to evaluate tolerability and absorption of drug administered via the vaginal route has been widely criticized on the basis of scientific and ethical considerations. Studies on animals can be substituted by validated in vitro tests as described in the guideline issued by Committee for Proprietary Medicinal Products (CPMP), now Committee for Medicinal Products for Human Use (CHMP) [112], Before an in vitro test can be considered valid, this test must undergo a procedure aimed at establishing its relevance and reliability. The relevance of the alternative test has to be compared with accepted in vivo standard methods. 

---