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ICH Guidelines by the FDA

The FDA requires clinical drug studies be carried out in accordance with the standards of the International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (mercifully abbreviated to ICH). Consisting of a joint commission of drug regulatory officials from Europe, Japan and the United States, the ICH reviews scientific and technical aspects of drug testing. The ICH strives for more economical use of resources and fast-tracking of important new medicines through its guidelines, which fall into four major categories: quality, safety, efficacy and multidisciplinary.

  1. Quality Guidelines

    • The ICH's quality guidelines relate to chemical and pharmaceutical quality assurance, or QA, of the drug. These guidelines include regulations for stability testing of new drug substances, impurities, manufacturing practices, risk management and the quality of biotechnological products. In other words, the ICH regulates how a drug is made and what it consists of.

    Safety Guidelines

    • Safety guidelines relate to in vitro and in vivo pre-clinical studies such as carcinogenicity, genotoxicity, reproductive impact and immunotoxicity. These recommendations provide guidance for testing of drugs either in animals or artificial environments such as a test tubes.

    Efficacy Guidelines

    • Efficacy standards relate to clinical studies in humans. Regulations include guidelines for ethnic factors, structure and content of clinical study reports, dose-response studies and pharmacogenics (the influence of genetic variation on the response of subjects to a test drug). The ICH also sets standards for clinical trials such as statistical rules, impact on geriatrics and selection of control groups.

    Multidisciplinary Guidelines

    • Recommendations that do not fit uniquely into the efficacy, safety or quality categories are classified as multidisciplinary guidelines. These areas of concern include medical terminology, electronic standards for the transfer of regulatory information, nonclinical safety for human drug testing, technical document specifications and standards for drug dictionaries.

    Guidelines for Guidelines

    • Not all guidelines issued by the ICH carry equal value. Rather, each guideline must go through a series of "steps" until it becomes a regulation that the FDA will implement and enforce. Step 1 guidelines are non-binding proposals developed by a committee of experts at the ICH. For Step 2, the ICH steering committee reviews the proposal and attempts to reach a consensus on a draft document. If they do, the guideline proceeds to Step 3 in which the FDA issues the proposal document to pharmaceutical companies to receive their input. During Step 4, the ICH revises the guideline based upon feedback from the pharmaceutical industry, after which the FDA will adopt the new rule.

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