This is a three-way harmonization process between Europe, Japan and the USA. It clearly reflects the priorities arising from the scientific and technological development of their respective pharmaceutical sectors, in which the main areas of activity are directed towards reaching an agreement on the issues of research, clinical trials and evaluation of new products.
One of the main obstacles that up to now has hindered the entry of new products in various international markets was actually the dissimilar criteria followed by the different national authorities on the regulation procedure of the entire research and development process of new pharmaceutical products. It even seemed more or less obvious that this area was too frequently becoming an obstacle quite «sui generis», which prevented easy access of foreign pharmaceutical products to each country.
The harmonization of regulations in this field is bound to produce two main effects: firstly, as mentioned above, to create an easier flow of new products into the international market without detriment to the surveillance and control function; secondly, the process of harmonization itself, in so far as it involves the exchange of information, technical discussion, etc. is meant to accomplish a substantial improvement in the quality of the research, development, and evaluation process of pharmaceutical products. Accordingly, the processes are not only harmonized and made more flexible, but they are also improved in terms of quality and their costs are significantly reduced.
There are three technical areas where the Conference is now working, each of them showing great progress in the following fields:
Validation of analytical methods
Monographs and pharmacopoeic methods
Handling of safety information: Drug surveillance
Population exposure and clinical safety (long-term therapy)
Ethnic factors and acceptance of data from other countries
Reports on clinical trials: structure...
These three areas cover most of the pharmaceutical research and development world-wide, and it was only an obvious consequence that efforts in harmonization were directed to create common principles, methods and regulations (specifically for activities in research and development). It should be expected that this harmonization process would give an important impulse to technological development, without sacrificing quality and without impairment to the State's commitment in surveillance and control.
Certain aspects (such as the evaluation of the relevance of ethnical factors), which used to be almost exclusively a reason for controversy, are now being studied in a harmonized fashion by trying to establish their true scope and by turning their conclusions into appropriate common regulations.