NATIONAL REGULATORY

Pesticides A. Comparative Study of Industrialized Nations Regulatory Systems, GAO/PEMD-93-17, U.S. General Accounting Office, Washington, D.C., July 1993,104 pp. 

Member states can nominate one expert and an alternative to each committee. These in effect come from the national regulatory bodies, which they also represent. The committees may additionally co-opt up to five other members. The committees can draw on the expertise of some 3500 scientists using a network that extends through the national regulatory bodies, and so form further advisory committees and working groups as appropriate. 

Throughout this book the regulatory regime is referred to as Labour Code , a translation of the French Code du Travail . All countries have national regulatory codes, some of which reflect wider imperatives (eg ED directories, ILO conventions, UN standards). In adddition, there are many technical and other codes of practice or procedure produced by national or international professional, technical and industrial organisations. Exampies of the former are the reguiatory codes of the HSE and The EA in the UK, and of OSHA and ERA in the USA and of the latter, the NFPA, which is referred to extensively in this book. 

NRC. 1996. Contribution of maternal radionuclide burdens to prenatal radiation doses. Washington, DC Office of Nuclear Regulatory Research, U.S. National Regulatory Commission. NUREG/CR-5631. 

This section describes the applicable national regulatory requirements for bleached, unbleached, and dissolving kraft mills. Potential pollutants of concern for kraft pulp mills as reflected in the effluent limitations guidelines and standards promulgated by U.S. EPA and in a sampling of NPDES permits are summarized in Table 21.12. 

Two rappoteurs are then appointed (committee members who are responsible for getting the application assessed). The rappoteurs generally arrange to have the application assessed by their respective home national regulatory authorities. Once assessment is complete, the reports are presented via the rappoteur to the CPMP. After discussion, the CPMP issue an opinion (i.e. a recommendation that the application be accepted, or not). This opinion is then forwarded to the European Commission, who have another 90 days to consider it. They usually accept the opinion... 

The mutual recognition procedure is an alternative means by which a marketing authorization may be sought. It is open to all drug types except products of biotechnology. Briefly, if this procedure is adopted by a sponsor, then the sponsor applies for a marketing licence not to the EMEA, but to a specific national regulatory authority (chosen by the sponsor). The national authority then has 210 days to assess the application. 

Japan. In Japan, the Koseisho is the national regulatory body for new drugs. 

The decision to approve a new drug is made by a national regulatory body (Food Drug Administration in the U.S.A., the Health Protection Branch Drugs Directorate in Canada, UK Europe, Australia) to which manufacturers are required to submit their appUca-tions. AppUcants must document by means of appropriate test data (from predinical and clinical trials) that the criteria of efficacy and safety have been met and that product forms (tablet, capsule, etc.) satisfy general standards of quality control. 

If national regulatory authorities can rely on safety test data developed abroad, duphcative testing can be avoided and costs saved to government and industry. Furthermore, a reduction in the number of laboratory animals used for testing of chemicals is an important goal in relation to animal welfare. 

In the pre-marketing phase of new drug development national regulatory authorities encourage and evaluate a broad range of experimental methods that come within the definition of clinical trials. 

Direct reporting of adverse drug reactions to national regulatory authorities has been possible... 

From 1945 to 1949, production was insignificant, averaging less than 10,000 pounds annually. For 1950 and 1951, production increased to 304,000 and 112,000 pounds, respectively U). There was no production at all from 1952 through 1959. In 1954 Alaska was expelled from the National Shellfish Council, the national regulatory body for shellfish, which meant clams could no longer be shipped out of state for human consumption. 

WHO can advise UNICH and other UN agencies whether vaccines and other medicines included in die prequaUfication scheme effectively meet WHO-recommended requirements only if die national regulatory audiority of die producing country exercises independent and appropriate oversight of die pharmaceuticals concerned, and if they have been adequately assessed by diat authority (WHO, 2002). 

Table 2. Minimum regulatory functions for a national regulatory authority (NRA)...

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