The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has developed a set of quality guidelines that are crucial for the safety, efficacy, and quality of pharmaceutical products. Here’s how these guidelines fit into the different phases of drug development:
Preclinical Development
- ICH M3 provides recommendations on preclinical safety studies for assessing potential risks.
- Guidelines like S6 focus on evaluating biotech drugs.
Clinical Development
- ICH E6 outlines ethical and scientific standards for clinical trials.
- E8 offers guidance on trial design and conduct.
- E9 provides statistical considerations for analyzing trial data.
Registration
- ICH M4 provides a harmonized format for submitting registration dossiers.
- M3 includes guidelines on quality aspects like impurities and stability testing.
Post-approval
- ICH Q5E guides manufacturers on assessing manufacturing changes’ impact on product quality.
- Q7 provides guidance on GMP requirements during API manufacturing.
Overall, these ICH quality guidelines ensure adherence to international standards, facilitating global regulatory acceptance and harmonization. They streamline drug development, enhance patient safety, and promote efficient regulatory review and approval.
Related: ICH Quality (Q) Guidelines and Their Relevance to Pharmaceutical Manufacturing
Resource Person: Ershad Moradi