European Union guideline applications

In addition to the unique regulatory structure in the European Union and the specific guidelines referred to above, there are a few other comments and issues relating to the interpretation and application of the ICH guidance. 

The major difference between application of the ICH S6 guideline in the European Union, compared to the United States and Japan, is the rather more complex interaction with the regulatory agencies in relation to agreeing on the preclinical testing strategy for biopharmaceuticals. While sponsor compa-... 

In its work, the SPPC uses 5 pharmacopoeias Russian, United States, British, Germcin and European Union (EU), as well as the corresponding Guidelines (Ministry of Health May 1996 July 1997). The SPPC may invite representatives of other bodies to review the applications. The SPPC collaborates with a number of local and foreign organizations of the same profile. The SPPC s recommendations are nonbinding and must be approved by the SCD. 

In 1996 and 1997 the International Conference on Harmonization (ICH) published guidelines for analytical method validation [8]. These documents present a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the European Union, Japan, and the United States. 

In addition to those items previously mentioned, the FDA is also participating in the development and use of international standards to facilitate pharmaceutical development. The goals of the International Conference on Harmonization of Technical Requirement for Registration of Pharmaceuticals for Human Use (ICH) is to facilitate the mutual acceptance of data submitted in support of drug marketing applications by the European Union, Japan, and the United States. The ICH has developed a number of guidelines and standards to harmonize post-marketing surveillance efforts on an international level. 

---