International Conference for Harmonization

Source International Conference for Harmonization. Good Clinical Practice. http //www. ich.org/ [accessed September 8,2007]. 

Source Adapted from International Conference for Harmonization. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, ICH Q7,2000. 

Source International Conference for Harmonization. Validation of Analytical Procedures ... 

International Conference for Harmonization (ICH) Quality and Safety Guidelines. http //www.ich.org/cache/compo/276-254-l.html... 

AU this makes good business sense and should eliminate the need for corrective work because of misunderstood validation requirements. Similar harmonization would appear to be occurring on the topics of electronic records and electronic signatures. Mutual Recognition Agreements (MRAs) between various national regulatory authorities such as the FDA, MHRA, TGA, and MHLW and the work of the International Conference for Harmonization (ICH) offer an opportunity to formally consolidate harmonized computer validation requirements. 

Validation is defined as the formal determination of the suitabUity of a given analytical method for an intended apphcation, achieving this by determining the rehabUity of results obtained [144], The following extract from the paper Vahdation of Analytical Results in Pharmaceutical Analysis by Renger et al. serves as the basis of this Chapter. Briefly, based on differences in requirements and even in definitions of terms used in the United States and Europe, experts from these coimtries and from Japan, who have been attending meetings of the International Conference for Harmonization (ICH 1-1CH 3) since 1993, have prepared a scheme of imiform requirements for the vahdation of analytical results [145]. The framework of the present book would be exceeded if all the details and commentaries were discussed here. The interested reader is therefore referred to the hterature [144]. 

International Conference for Harmonization (meetings of experts held at irregular intervals to produce uniform guidelines for the validation of analytical methods worldwide)... 

ICH (International Conference for Harmonization). 2000. S7A Safety pharmacology studies for human pharmaceuticals. Geneva International Conference for Harmonization. 

The method was validated in accordance to the guidelines of the international conference on harmonization (ICH). Data with respect to accuracy, within- and between run precision, recovery, detection and quantitation limits were reported and found to be within the accepted international criteria. Neither endogeneous substances nor the commonly used dmgs were found to interfere with the retention times of the analytes. Standard solutions of the dmg and quality control preparations at high and low level concentrations were demonstrated to be stable at room temperature and/or -20°C for long and short periods of time. 

Fig. 13-1. International Conference on Harmonization (ICH) process for developing harmonized guidelines.

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use... 

The Electronic Common Technical Document (eCTD) is the vision for future electronic submissions to the FDA. This specification was developed by the International Conference on Harmonization (ICH) as an open-standards solution for electronic submissions to worldwide regulatory authorities. The FDA has adopted the eCTD as the future replacement for its other e-submission guidance, although for now the older guidance is still in effect. Note that the eCTD still depends largely on submitting text documents as PDF files and submitting data sets as SAS XPORT transport format files. 

The Medical Dictionary for Regulatory Activities (MedDRA) is a creation of the International Conference on Harmonization, and it is used to categorize and code diseases, disorders, and adverse events. The five levels and associated codes to the MedDRA coding hierarchy are as follows ... 

Timing of Non-Clinical Safety Studies for the Conduct of Human Clinical trials for Pharmaceuticals. Fourth International Conference on Harmonization. International Conference on Harmonization, Brussels, 1997. 

In recent years, regulatory authorities and industry associations have undertaken several important initiatives to promote international harmonization of regulatory requirements. These efforts are designed to enhance harmonization and are committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. These efforts are undertaken under the auspices of the International Conference on Harmonization (ICH), which is organized to provide an opportunity for tripartite... 

International Conference on Harmonization, Validation of analytical procedures methodology, step 2. The Third International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Yokohama, Japan. Nov. 29-Dec. 1, (1995). 

The single-dose toxicity studies were performed in two mammalian species, rat and mouse, by the route used in clinical practice, that is oral, as well as that ensuring adequate systemic exposure to the drug, that is intravenous. The subacute (3 months) toxicity studies were correctly carried out in the two animal species (rat, dog) in which also the pharmacokinetics was studied. Since in accordance with the International Conference on Harmonization (CPMP/ICH/286/95), 3-month toxicity studies support clinical trials for up to 1 month s duration (the longest duration of drug administration in clinical use), chronic toxicity studies have not been performed. 

The International Conferences on Harmonization has published its document S6, Preclincial Safety Evaluation of Biotechnology-Derived Pharmaceuticals. The FDA (the Center for Drug Evaluation and Research, and the Center for Biologies Evaluation and Research jointly) has published the document as a Guidance for Industry (Anon., 1997a, b FDA, 1989, Hayes and Reyffel, 1999). 

FDA International Conference on Harmonization Guideline on detection of toxicity to reproduction for medicinal products. Federal Register, September 22, 1994, Vol. 59, No. 183. 

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