The Competent Regulatory Bodies

All QSARs should be associated with a clear scientific and regulatory purpose. A possible outcome of the peer-review step is the recommendation that the validated QSAR should be considered for inclusion into a regulatory framework. In such a case, the recommendation, and all of the supporting evidence, should be forwarded to the appropriate regulatory body (or bodies) for consideration. In the EU, if the QSAR is considered suitable for the assessment of chemicals, deliberations take place at a technical level by the National Coordinators for Testing Methods, and subsequently, a decision is taken at the policy level by representatives of the EU Competent Authorities for Directive 67/548/EEC. 

The ECMRA applies to medical devices manufactured in the EC, Australia and New Zealand. It recognises the competence of designated conformity assessment bodies (CABs) in the EC to undertake conformity assessment of medical devices to Australian regulatory requirements, and the competence of the TGA to undertake assessment of medical devices for compliance with the requirements for certification (CE Marking) for entry onto the EC market. 

The National Drug Institute was reorganized as a regulatory body which now operates as a competent authority (See Figure 1). It is considered by many local and international partners to be a quick and effective institution. The old manual record-keeping approach of the NDI was replaced by an automated information management system. Electronic submission of information is now possible. 

The cellular mechanism of lead nephrotoxicity appears to be due to an alteration of calcium homeostasis. Lead (Pb ) competes with calcium (Ca " ") for transport, binding to calmodulin and at other cell calcium regulatory sites. Lead can accumulate in mitochondria using the calcium transporter and disrupt respiration. Interactions of lead with calmodulin can result in a disruption of the calcium messenger system to adversely affect normal cell function. The nuclear inclusion bodies may also alter the cellular function of DNA, although this interaction has not been fully elucidated. 

Perhaps the most thoughtful and valuable contribution of the Commission was its 1993 presentation Health Professions Education for the Future Schools in Service to the Nation and subsequent revisions of competencies (Table 1 ) for successful practice in the 21st century. This effort has been used uniformly across the health professions by schools, professional associations, accrediting agencies, and regulatory bodies. 

The holder of the marketing authorization, the appropriate national and/or international regulatory bodies, as well as other relevant competent authorities, should be informed immediately. 

However, subjective and objective analyses of these devices are required to make sure both scientific, regulatory and consumer needs are met. The devices in development are costlier and more complicated when compared with conventional transdermal patch therapies. As such they may contain electrical and mechanical components which could increase the potential safety risks to patients because of poor operator technique or device malfunction. In addition, effects of the device on the skin must be reversible, since any permanent damage to the SC will result in the loss of its barrier properties and hence its function as a protective organ. Regulatory bodies will also require data to substantiate the safety of the device on the skin for either short- or long-term use. Thus, for any of these novel drug delivery technologies to succeed and compete with those already on the market, their safety, efficacy, portability, user-friendliness, cost-effectiveness and potential market have to be addressed. 

The regulatory body shall employ a sufficient number of personnel with the necessary qualifications, experience and expertise to undertake its functions and responsibilities. It is hkely that there will be positions of a specialist nature and positions needing more general skills and expertise. The regulatory body shall acquire and maintain the competence to judge, on an overall basis, the safety of facilities and activities and to make the necessary regulatory decisions (Ret [1], para. 4.6). 

In order to ensure that the proper skills are acquired and that adequate levels of competence are achieved and maintained, the regulatory body shall ensure that its staff members participate in well defined training programmes. This training should ensure that staff are aware of technological developments and new safety principles and concepts (Ref [1], para. 4.7). 

The regulatory body is to be provided with adequate authority, competence and financial and human resources. It shall be empowered to enforce legal requirements to issue, amend, renew, suspend or cancel licences or authorizations or to recommend such actions to the government. 

The organizational framework of a regulatory body may vary from country to country, but in all cases the regulatory body must have the statutory authority, competence and resources ... 

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