National Health Products Regulations

The saccharin content in candied fruits sold in market was also surveyed (Table II). According to Chinese National Health Administration regulations, candied fruits with water content below 25 % may contain up to two grams of saccharin and/or cyclamate per kilogram of product. This survey showed that 70 % of the samples had excessive amounts of these sweeteners. These artificial sweeteners were found in about four-fifths of the samples with a water content above 25 %. 

Drinking water intended for human consumption is the most protected foodstuff worldwide and thus many national and international regulations have been introduced to assure a safe drinking water supply. In general, drinking water must be of a quality that under no circumstances would present a hazard to human health. In many countries, such as Germany, standards for water resources that may be used for drinking water production are specified [1]. 

The provisions of the new Regulation (EC) 726/2004 do not affect the powers of Member States authorities as regards setting the prices of medicinal products or their inclusion in the scope of the national health system or social security schemes on the basis of health, economic and social conditions. In particular, Member States shall be free to choose from the particulars shown in the marketing authorisation those therapeutic indications and pack sizes which will be covered by their social security bodies. 

From a health perspective, there are few redeeming features of solvents except when used as anesthetics. Clearly the simple recommendation is to avoid exposure unless administered for some medical reason. In the workplace, appropriate ventilation and personal safety equipment should be in place at all times. There are numerous national and international regulations on solvent exposure in the workplace. Substitution of less-toxic solvents in processes and products can reduce the risk of injury. 

Marie-Daniele Campion is a Doctor in Law and a Doctor in Pharmaceutical Science. She is Professor of Health Law and Economics at the University of Lille II where she coordinates a course in the regulation of health products in the EU and another course in the assessment and negotiation on health products with the University of Paris V. She is also in charge of drug regulation at the Ministry of Economy. Dr. Campion is a member of the French National Academy of Pharmacy. She has been involved in European harmonisation for 20 years, focusing her research in that field. She has given more than 100 lectures and has written for more than 60 publications. 

Directive 89/105/EEC of December 21,1988, relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of national health insurance systems (transparency of price and reimbursement). 

The international, national, and state regulations and guidelines regarding total petroleum hydrocarbons (TPH) in air, water, and other media are summarized in Table 7-1. No health or environmental benchmarks have been developed for TPH as a general category, though many exist for individual petroleum chemicals or products, such as gasoline. 

In the United Kingdom, the government controls the cost of pharmaceuticals not by limiting individual product prices, but by setting a cap on the profit that individual pharmaceutical companies can enjoy from their business with the National Health Service. Each company negotiates with the Secretariat of Pharmaceutical Price Regulation Scheme (PPRS) a total rate of return on the capital employed in generating its sales to the British National Health Service (NHS). 

The PCP Act, which is administered through the Department of Agriculture, and the F D Act, which is administered through the Department of National Health and Welfare (NHW), require premarket testing and evaluation of products prior to commercialization. Both of these Acts appear to be sufficiently broad to enable regulation of both chemicals and microbes developed through biotechnology. 

Lead in the Canadian diet is regulated under two Federal statutes The F D Act for Pb as a contaminant in various categories of foods, including infant formulae in the Canadian diet, and leachable Pb levels from ceramic ware and food utensils through the Hazardous Products Act. Food health and safety standards are established by Health Canada and enforced by agencies such as the Ministry of National Health and Welfare. 

The duties of EU manufacturers with respect to adverse-event notification and evaluation have been regulated in the Product Safety Directives, but for the operation of a vigilance system to enhance patient safety, there are only guidelines and no law. In practice, this means that EU manufacturers are obliged to notify any adverse event to the competent authority of their country (e.g., the medical device agency of the National Health Inspectorate). The... 

The second method of price controls, using profit caps, is employed in, for example, the United Kingdom through the Pharmaceutical Price Regulation Scheme (PPRS), whereby the government negotiates a reasonable profit with companies for products sold to the National Health... 

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