ICH guidelines are clear and rationally grounded scientific frameworks focused on standardizing documentation and assessment for pharmaceutical products. These guidelines typically cover four broad sections:

• Quality (Q)
• Safety (S)
• Efficacy (E)
• Multidisciplinary (M)

They are oriented to drug development, regulatory submissions, and lifecycle of products guiding them towards widely acceptable expectations. [2]

Currently, regulatory risks can be minimized and delays and issues in approval can be avoided or resolve easily, and product standards will be consistent across international markets. ICH guidelines must be observed for all Clinical Research Organization’s (CRO), biopharma firms, and regulatory affairs groups to have a plan for international submissions. [3]

Quality Guidelines (Q Series)

The ICH guidelines cover every pharmacist quality element from manufacturing, analytical validation, risk management and Good Manufacturing Practice (GMP). The major documents are:

• ICH Q8 (Pharmaceutical Development)
• ICH Q9 (Quality Risk Management)
• ICH Q10 (Pharmaceutical Quality System)

Safety Guidelines (S Series)

The S-series covers all safety protocols for evaluating toxicological risks referred to as Genotoxicity, Carcinogenicity and Reproductive Toxicity. Some Examples are:

• ICH S1 (Carcinogenicity Studies)
• ICH S6 (Preclinical Safety Evaluation of Biotechnology Derived Pharmaceuticals)

Efficacy Guidelines (E Series)

The E-series covers all design, conduct and safety reporting with GCP while conducting clinical trials Examples include:

• ICH E6(R2) – Good Clinical Practice
• ICH E3 – Clinical Study Reports
• ICH E5 – Ethnic Factors in the Acceptability of Foreign Clinical Data

Multidisciplinary Guidelines (M Series)

The M series includes general guidelines that will cover more than one category; examples include:

• ICH M4 – Common Technical Document (CTD)
• ICH M7 – Assessment of DNA-reactive Impurities [2]

ICH guidelines are enforced by regulatory authority in ICH member countries and are frequently used by non-member countries. Harmonization reduces regulatory uncertainty, increases efficiency and improves access for multi-country submissions, and supports the global public health missions. [4]

Common challenges when it comes to ICH compliance, include:

• Incomplete submissions meeting ICH-approved templates
• Lack of compliance with the goals of safety and efficacy data
• Differences in region-specific interpretations regarding applications of guidelines.

Building relationship with regulatory experts early on in your project, and considering ICH guidelines and approved templates, will help to alleviate these challenges. [5] 

We provide regulatory writing and support services to assist our clients in developing ICH compliant documents for clinical and regulatory submissions. From ICH E3 Clinical Study Reports, to developing CTD modules (ICH M4), we assist you in ensuring technical compliance, regulatory compliance, and that your submissions are ready for global submissions. We support you in keeping on top of the ever-evolving updates including ICH E6(R3) and will also help you to ensure you meet these expectations of the EMA, FDA, and PMDA.