Self-regulation certification

The Medicines Act 1968 included the definitions of a clinical trial and of a medicinal product. Clinical studies involving healthy volrmteers did not meet this definition of a clinical trial and, as a result, did not come under the remit of regulatory controls. Such studies were subject to self-regulation by the pharmaceutical industry. Consequently, only the clinical trials in patients had to be covered by a clinical trial certificate (CTO. 

The success of self-regulation depends to a large extent on the honesty and integrity of those following its regime. There is something of a parallel in the self-certification of machinery allowed under the Machinery Directive s but this requires the support of documentary evidence which can be examined. 

There has been a clear shift, in parallel with the move to self-regulation and safety management rules, towards involvement of the regulated in this process. In the certification system described in Gundlach s chapter this goes a step further, with the desire, but also the problem, of involving all interested parties, including employees and consumers. 

Building Regulations - Part P 2006 and the self-certification scheme... 

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