Future perspectives of regulations — harmonization of data requirements
Current EEC Directives provide good general guidance on the format of documentation while specific Directives aid the planning of drag development programmes.
The conditions under which clinical research programmes can be started still vary considerably and require harmonization.
To aid harmonization scientific issues must be separated from economic ones.
Adverse event reporting for products already on the market still lacks uniformity.
The highly complex area of biotechnology products is changing rapidly and requires careful attention in order to avoid unnecessary obstruction through legislative control.
KeywordsMember State Data Requirement Registration Process Marketing Authorization Adverse Event Reporting
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