Since the birth of the ICH (International Council for Harmonisation of Technical Requirements in Pharmaceuticals for Human Use) in 1990, the organization has been the main body regulating guidelines for medicines produced on a global scale to guarantee the quality, effectiveness and over all safety of drug development in the pharmaceutical industry.
When regulating the quality of pharmaceuticals, the ICH has a number of different processes to ensure the safety of all new drug products. First is a stability test which involves understanding the most effective temperatures to store products appropriately to suit a global regime. Then there is the assessing sensitivity and dosage forms in new or new types of existing drugs. Rigorous stability testing to provide data on shelf life and the performance of drugs over time when impacted by various environmental and climatic factors is also done. There is also an evaluation to determine if existing methods will remain applicable overtime or a re-evaluation is required.
Part of the application process is to provide validation on analytic methods used when assessing drug characteristics. Impurities are another aspect to take into consideration when registering a pharmaceutical product especially when it comes to new synthetic substances. Reactions to packaging and other materials the substance might come into contact with that may form impurities are also taken into account.
This section is to produce the intended results that are stated with the introduction of a pharmaceutical product. The first stage is to fully determine the number of patients and the duration of exposure to a subject for long-term treatment when dealing with non-life-threatening ailments.
Another important aspect is to plan how as a developer you are going to avoid adverse effects with post-marketing strategies. The efficacy guidelines also state the need provide regular safety updates to show consistency and minimize risks after the product has been marketed, involving interval safety reports, a cumulative benefit-risk report and an aggregate data evaluation.
Determining the negative effects that a drug has on cells is a key feature of the ICH’s safety guidelines and provides a host of tests that can improve consistency leading up to the application. Providing guidelines on products that do not require animal tests to reduce the use and harm potential harm to animals.
If necessary, a two-year rodent test is one option to see the potential risks to the human body and involves multiple dose toxicity tests over a 6-12 month period to get a better understanding of the long-term negative effects on cells.
The multidisciplinary guidelines are guidelines that don’t quite fit into quality, efficacy and safety guidelines. There is a terminology dictionary available in English and Japanese which provides examples, further guidance and popular questions that have been previously asked. It also provides parameters and types of non-clinical tests that support the development of pharmaceuticals.
Last but not least, there is a global glossary of medical products available for public viewing with technical vocabularies and lists of accepted measurements. The Gene Therapy Discussion Group (GTDG) produced a document for the ICH called ‘General Principles to Address Virus and Vector Shredding’ which lead to the evolution of ICH guidelines to provide further information on this topic to provide consistency in participating ICH regions.