International Commission Harmonization

International Commission for Bee Botany (1980) Symposium on the harmonization of methods for testing the toxicity of pesticides to bees. ICBB, Wageningen... 

Inabe, T., Goto, H., Fujinawa, T., Ahashi, H., Ogata, H., Miyajima, S. and Maruyama, Y. (1996). Unusual electrical properties of 1,6-diaminopyrene charge-transfer complex crystals. Mol. Cryst. Liq. Cryst., 284, 283-90. [82, 193] International Commission on Harmonization. (1996). Q2B validation of analytical procedures methodology. [122]... 

Perhaps surprisingly, there has been a variation in the definition of the terms infant , child and adolescent between texts or stndies. To overcome this, the International Commission on Harmonization has defined these terms for regulatory purposes (European Agency for the Evaluation of Medicinal Products, 2000). These definitions and age bands (Table 1.1) broadly represent the ages at which the major changes... 

Notwithstanding that a large number of definitions exist that have been produced and harmonized by many commissions of international organizations (e.g., IUPAC, IUPAP, ISO, BIPM, IEC, IFCC, OIML), there are still official recommendations and definitions which are not completely satisfying and sometimes confusing (Prichard et al. [2001]). 

IUPAC (1993) Analytical Chemistry Division, Commission on General Aspects of Analytical Chemistry The International Harmonized Protocol for the Proficience Testing of (Chemical) Analytical Laboratories. Pure Appl Chem 65 2123... 

This "new" approach has been in use for many years in most European countries. Originally, each country had their own national requirements. Then, based on the work done by the lEC (International Electrochemical Commission), standards were harmonized through the work of CENEEEC (Comity Europ en de Normalisation Electrotechnique). Harmonized standards, published as European Standards (EN), have to be adopted by the participating countries as national standards. Some of the countries which have already adopted these are Belgium, Erance, Germany, and the United Kingdom. 

Under this definition, the value of IHDX is always 100%. This method of quantifying the harmonics is known as harmonic distortion based on the fundamental. This is the convention used by the Institute of Electrical and Electronic Engineers (IEEE) in the U.S. The European International Electrotechnical Commission (IEC) quantifies harmonics based on the total RMS value of the waveform. Using the same example shown above, the RMS value of the waveform is ... 

In order to harmonize SPS measures on as wide a basis as possible, the SPS agreement encourages members to base their SPS measures on international standards, guidelines, or recommendations. Thus, the SPS agreement, like the new TBT agreement, encourages use of international standards. The SPS agreement refers specifically to standards established by the Codex Alimen-tarius Commission, as discussed below. 

FC EMEA FDA GCP GMO HAP HEPA HIV HTLV ICH European Commission European Medicines Agency Food and Drug Administration good clinical practices genetically modified organisms hamster antibody production high efficiency particulate air human immunodeficiency virus human T-Cell leukemia virus International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use... 

ICH 1, the first international ICH meeting, was held in Brussels in November of 1991. This meeting, sponsored by the Commission of the European Communities and the European Federation of Pharmaceutical Industries Associations (EFPIA), was composed of three parallel workshops on the topics of Quality, Safety, and Efficacy and identified 11 topics for harmonization. 

In 1991, the Commission of European Communities, the FDA, the Japanese Ministry of Heath and Welfare, the International Federation of Pharmaceutical Manufacturers Associations, the European Federation of Pharmaceutical Manufacturers Associations, the U.S. Pharmaceutical Manufacturers Association and the Japanese Pharmaceutical Manufacturers Association organized the first International Conference on Harmonization (ICH). The goal of the conference was to begin to harmonize requirements for regulatory submissions in the United States, Europe and Japan in the areas of quality, safety, and efficacy. One of the quality topics was stability testing. 

Assignment of Documentation and Finished Product. Documentation and samples of finished products are sent to the evaluation unity. The evaluator excim-ines the technical file with reference to different current pharmacopoeia, i.e., the European Pharmacopoeia to which commission Tunisia is adherent as an observer, the American Pharmacopoeia, the British Pharmacopoeia and to the documents issued by the International Conference of Harmonization (ICH), to the guidelines of the World Health Organization (WHO), to the decisions taken by the European Committee for Proprietary Medicinal Products (CPMP) and to a set of bibliographic references. 

International Conference on Harmonisation (ICH) The ICH was formed to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. The ICH is sponsored by the European Commission, the European Federation of Pharmaceutical Industry Associations, the Japanese Ministry of Health and Welfare, the Japanese Pharmaceutical Manufacturers Association, the U.S. Food and Drug Administration, and the Pharmaceutical Research and Manufacturers of America. The objective of the ICH is to harmonize the technical requirements for the registration of pharmaceutical products in the European Union, Japan, and the United States. 

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