Drug development is primarily driven by three factors: quality, efficacy, and safety. The essential quality, nonclinical safety, and efficacy standards that are established by the assessment of the new drug’s clinical efficacy and safety for its intended therapeutic indications in accordance with the ICH guidelines were covered in the previous few blogs. We’ll concentrate on the important ICH multidisciplinary guidelines today. The main objective of the multidisciplinary guidelines is to harmonize the dossier within the ICH regions. Another important objective is to streamline the regulatory review process and bring in uniformity in the assessment, review and the rendered opinion from the experts and regulators to the applicant. Such a harmonization reduces time lags, brings in objectivity in the assessment, leads to transparency and helps to maintain quality of review and delivery of the regulatory decision.
These guidelines include topics that are unique and do not fall under the area of quality, safety, and efficacy guidelines. Multidisciplinary Guidelines provides information on the Common Technical Document (CTD), medical terminology (MedDRA), and the creation of Electronic Standards for the Transfer of Regulatory Information (ESTRI). Here, we present the main titles of the various multidisciplinary parameters considered by the ICH guidance during the clinical development.
M1 – MedDRA Terminology
- M1:MedDRA – Medical Dictionary for Regulatory Activities
- M1 PtC WG: MedDRA Points to Consider
M2 – Electronic Standards
- M2 EWG: Electronic Standards for the Transfer of Regulatory Information
M3 – Non clinical safety studies
- M3(R2): Guidance on Non Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
- M3(R2) Q&As (R2): Questions & Answers: Guidance on Non Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
M4 – Common Technical Document
- CTD: The Common Technical Document
M5 – Data elements and standards for drug dictionaries
- M5: Data elements and standards for drug dictionaries
M6 – Gene Therapy
- M6: Virus and Gene Therapy Vector Shedding and Transmission
M7- Mutagenic Impurities
- M7(R2): Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risks
- M7(R2) Q&As: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risks
- M7(R3) Maintenance EWG/IWG: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risks
M8 – Electronic Common Technical Document (eCTD)
- M8 (eCTD) v3.2.2: Electronic Common Technical Document (eCTD)v3.2.2
- M8 (eCTD) v4.0: Electronic Common Technical Document (eCTD)v4.0
- M8 EWG/IWG: Electronic Common Technical Document (eCTD)
M9 – Biopharmaceutics Classification System – based Biowavers
- M9: Biopharmaceutics Classification System-based Biowavers
- M9 Q&As: Q&As on Biopharmaceutics Classification System-based Biowavers
M10 – Bioanalytical Method Validation and Study Sample Analysis
- M10 EWG: Bioanalytical Method Validation and Study Sample Analysis
- M10 Q&As: Questions & Answers: Bioanalytical Method Validation and Study Sample Analysis
M11 – Clinical electronic Structured Harmonised Protocol (CesHarP)
- M11 EWG: Clinical electronic Structured Harmonised Protocol (CesHarP)
M12 – Drug Interaction Studies
- M12 EWG: Drug Interaction Studies
M13 – Bioequivalence for Immediate-Release Solid Oral Dosage Forms
- M13 EWG: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
M14 – Use of real-world data for safety assessment of medicines
M14 EWG: General Principles on plan, design, and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines
M15 – General Principles for Model-Informed Drug Development
- M15 EWG: General Principles for Model-Informed Drug Development
In conclusion, multidisciplinary guidelines are designed to support the ICH guidelines support in the development and registration of safe and effective pharmaceutical products by harmonizing regulatory standards across various geographic areas. These recommendations are frequently followed by pharmaceutical firms and regulatory bodies in ICH member regions to speed up the development and approval of medicines around the world. Regulatory agencies like the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) routinely include ICH standards into their regulatory procedures. These regulations make it simpler for pharmaceutical companies to create and market medicines across numerous sectors, ensuring that patients have access to safe and effective pharmaceuticals. They also serve to promote global consistency and collaboration in the pharmaceutical business. In addition to these fundamental multidisciplinary guidelines, one should additionally take note of the unique standards established for items made utilizing biotechnology, etc. Many non-ICH regions have also benefited from these guidelines and are harmonizing their national requirements on the similar technical dossier as per the CTD formats. This in turn is helping non-ICH drug developers to introduce their products in the ICH regions.
