International Conference of Drug Regulatory Authorities

It was noted that this Committee provided a mechanism to implement recommendations from the International Conference of Drug Regulatory Authorities (ICDRA). 

The Committee was informed that preparations for the 12th ICDRA were under way and that it would be held in April 2006, in Seoul, Republic of Korea. Recommendations from previous ICDRA meetings were addressed, including those related to fixed-dose combinations. 

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ICDRA International Conference of Drug Regulatory Authorities... 

Hartley, B. 1994. Seventh International conference of Drug Regulatory Authorities, The Hague, Netherlands. P. 10 in WHO/DMP/ICDRA/94 1. 

The quantitative determination of analytes in biological matrices such as blood, urine, etc. is called bioanalysis. Regulatory authorities and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance requires that the concentration-time profiles of drugs and/or metabolites in man or in animals are studied so their respective pharmacokinetics can be calculated and used as a basis for the evaluation of pre-clinical (especially toxicological) and clinical studies. 

As required by regulatory authorities [1-3, 6] and International Conference on Harmonisation (ICH) guidelines [7], analytical method validation is especially important in establishing the assay methods and procedures of quantitative or semi-quantitative measurement of target substances or compounds. Among the specification items for drug products, assay, content uniformity, and dissolution are typical of those which require almost full analytical validation. The purity test, related... 

The data requirements for approval of a drug are fairly uniform across the world, but there are major differences in the formats in which these data are presented in the dossiers to various regulatory authorities. This has meant ineffective use of effort and manpower. In order to reduce the time and resources needed to compile applications and to facilitate electronic submissions, regulatory reviews and communications and exchange of information between regulatory authorities, the International Conference... 

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