European design guidelines

The Europeans, meanwhile, have focused on the need for better care in study design, conduct and interpretation (Spindler et. al., 2000), aiming to incorporate these in the revision of the CPMP (Center for Proprietary Medicinal Products) carcinogenicity guidelines. 

There were major differences in the protocol designs for rodent studies between Japanese and European studies. These were resolved by the ICH, which in 1993 published a guideline entitled Detection of Toxicity to Reproduction for Medicinal Products. ... 

In the European Union, the design, manufacture, and use of pressure systems is covered by the Pressure Equipment Directive (Council Directive 97/23/EC) whose use became mandatory in May 2002. European standard EN 13445 provides similar rules and guidelines to the ASME BPV Code. The design of fiber-reinforced plastic vessels is covered by European standard EN 13923. 

The ICFI has recently (1994) promulgated harmonized testing guidelines for reproductive toxicity in five study designs adopted by the European Union, Japan, and the United States in 1996 (Figure 4). 

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