Regulatory authorities clinical trial guidelines

The Clinical Trials Directive requires the integration of the GCP guidelines into the national law of all MS (which had not been the case in some MS before May 2004). Local regulatory authorities now carry the burden of inspecting for compliance with both GCP and the GMP guidelines for investigational drugs. Inspections take place at both sponsor s facilities and clinical trial sites. 

Unfortunately, the GCP guidelines are not always applied to other biomedical research and rarely to independent studies on marketed products initiated by clinicians without support from the manufacturer. There is still a double standard in therapeutic research and therefore in published papers arising from them. Editors and reviewers do not see the full documentation of non-sponsored biomedical research, whereas the regulatory authorities and their expert advisers will expect to see all data in the support of new medicines. The extent of the differences in standards is recognised when a potential investigating site is visited and one realises that there are no SOPs, that documentation of laboratory procedures is suboptimal and that staff are not properly trained. These facets are mentioned because the training that clinicians, scientists and technicians receive from company-based staff before and during a sponsored clinical trial adds considerably to the quality standards. 

Apart from the capital cost, other issues must be considered. cGMP requires the industry to follow strict guidelines as laid out by the relevant regulatory authorities (87). Broadly this may be classified into two categories (a) properly designed, installed, and commissioned equipment and (b) a reliable and consistent process. Validation is crucial for both process and equipment and must be successfully completed and demonstrated prior to the manufacture of any drug for clinical trial or for sale. The robustness of the process can be... 

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