National regulatory bodies

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. 

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. 

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. 

In contrast, the patient and the patient s family may be very interested in the outcome that this therapy has on the caregiving burden on the other hand, they may not be interested in the direct costs of the therapy for which they are not directly responsible. Most national regulatory bodies, such as the NICE in the UK. prefer a comprehensive, societal perspective on a drug s value because such a perspective incorporates all these variables. This broader perspective examines direct costs, caregiving costs and indirect costs. 

A final point that also needs to be presented is related to quality assurance, i.e. the requirement to satisfy regulatory frameworks concerned with safety and environmental issues. Traditionally, only national regulatory bodies had to be satisfied. Now, however, international regulatory bodies have to be satisfied while national regulatory bodies must, in many cases, accept the regulations of other nations. In this context, quality assurance of a plant or a process may often require a demonstrable pedigree for each number in the calculation of some aspect of the plant. 

In British Columbia, the authorities have sought to take as a standard the reference drug that is most cost-effective within its class[2], based their choice on the scientific evidence as accepted by the national regulatory body. The figures for cost-effectiveness take into account the cost structure of the Canadian health system, but not necessarily the health care structures specific to the British Columbia province. 

The Requirements Management System is a necessary precondition for the organisation, management, coordination, inspection and evaluation of the extensive project, both from the viewpoint of the contractor and customer, as well as from the viewpoint of the national regulatory body. It is a tool for systematic identification, requirement structuring, communication, control, monitoring and verification of user... 

Information may be exchanged by means of meetings, submissions of documents, visits by experts and participation in inspections, but none of these means should in any way relieve the national regulatory body of its responsibilities for making decisions or recommendations. 

This Safety Guide, which is jointly sponsored by the FAO, the IAEA, the International Labour Office, the PAHO and the WHO, gives detailed guidance on the key elements for the organization and operation of a national regulatory infrastructure for radiation safety, with particular reference to the functions of the national regulatory body that are necessary to ensure the implementation of the Basic Safety Standards. The Safety Guide is based technically on material first published in IAEA-TECDOC-1067 which was jointly sponsored by the FAO, the IAEA, the OECD/NEA, the PAHO and the WHO. The requirements established in GS-R-1 have been taken into account. 

Now, national regulatory bodies accept only data obtained after such re-evaluation and reconstitution - these data are also the bases for new trend curves given by Eq. 5.4. 

After completion of the review the team leader prepares the final review report based on the draft report. This is an official IAEA record which summarizes the team s main observations and conclusions including all recommendation and suggestions. Before the text is finalized the utility is given the opportunity to comment. This report is submitted through official channels to the Member State which hosted the mission. The IAEA restricts initial distribution to itselt members of the review team, the nuclear power plant, the utility and the national regulatory body. The report is derestricted after a specified period of time unless the Member State wishes otherwise. 

The engineering design rules for stractures, systems and components shall be specified and shall comply with the appropriate accepted national standard engineering practices (see para. 3.6), or those standards or practices already used internationally or established in another coimtry and whose use is applicable and also accepted by the national regulatory body. 

The information provided by this report is intended primarily for code users performing accident analysis. Regulatory bodies are encouraged to use the report as the basis for their national requirements. Analysts may also use the report as a reference for contacts with the national regulatory body or for the formulation of detailed company procedures for analysts. 

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