A List Of Products That Are Not Tested On Animals ICH Guidelines for Pharmaceuticals

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ICH Guidelines for Pharmaceuticals

Since the birth of the ICH (International Council for the Harmonization of Technical Requirements in Pharmaceuticals for Human Use) in 1990, the organization has been the main body that regulates the guidelines for drugs produced on a global scale to ensure the quality, effectiveness and above all the safety of drug development in the pharmaceutical industry.

Quality guidelines

When regulating the quality of pharmaceutical products, ICH has a number of different processes to ensure the safety of all new drug products. First is a stability test that involves understanding the most effective temperatures to store products appropriately to fit a global regime. Then there is the assessment of sensitivity and dosage forms in new or new types of existing drugs. Rigorous stability testing is also done to provide data on the shelf life and performance of the drugs over time when affected by various environmental and climatic factors. There is also an assessment to determine whether existing methods will remain viable overtime or a re-evaluation is required.

Part of the application process is to provide validation of the analytical methods used when evaluating the properties of the drug. Impurities are another aspect to consider when registering a pharmaceutical product, especially when it comes to new synthetic substances. Reactions to packaging and other materials with which the substance may come into contact and which may form impurities are also taken into account.

Efficiency guidelines

This section is to produce the intended results that are stated with the introduction of a pharmaceutical product. The first stage is the complete determination of the number of patients and the duration of exposure to a subject for long-term treatment when dealing with non-life-threatening diseases.

Another important aspect is to plan how as a developer you will avoid negative effects with post-marketing strategies. Efficacy guidelines also state the need to provide regular safety updates to demonstrate safety and minimize risks after the product is marketed, including interval safety reports, a cumulative benefit-risk ratio, and an assessment of overall data. .

Safety instructions

Determining the adverse effects a drug has on cells is a key feature of the ICH safety guidelines and provides a host of tests that can improve robustness leading to application. Providing guidelines for products that do not require animal testing to reduce use and potential harm to animals.

If necessary, a two-year rodent test is an option to look at potential risks to the human body and involves multiple-dose toxicity tests over a 6-12 month period to better understand long-term adverse effects on cells.

Multidisciplinary guidelines

Multidisciplinary guidelines are guidelines that do not fully align with quality, efficacy, and safety guidelines. There is a glossary of terms available in English and Japanese, which provides examples, further guidance, and popular questions that have been asked before. It also provides parameters and types of non-clinical tests that support the development of pharmaceuticals.

Last but not least, there is a global medical product dictionary available for public viewing with technical glossaries and lists of accepted measurements. The Gene Therapy Discussion Group (GTDG) produced a document for ICH called “General Principles for Addressing Viruses and Vector Shredding” which leads to the evolution of ICH guidelines to provide further information on this topic to ensure consistency in participating ICH regions.

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