The M4Q guideline harmonizes the format of quality information within the Common Technical Document (CTD) for pharmaceutical product registration.
In more detail, the M4Q(R1) guidelines, introduced in 2002, aimed to standardize the quality information submitted for regulatory approval of pharmaceuticals intended for human use. This standardization offers numerous benefits to various stakeholders:
- Industry: Simplified and streamlined preparation of regulatory submissions across different regions.
- Regulators: Facilitated efficient review and assessment of quality information.
- Patients and Consumers: Enhanced assurance of product quality and safety through improved regulatory oversight.
The M4Q guideline falls under the broader umbrella of the Common Technical Document (CTD), which provides a standardized format for submitting information to regulatory agencies across various regions, simplifying the drug approval process. By standardizing the "Quality" section (Module 3) of the CTD, M4Q ensures that consistent and comprehensive information is provided about the manufacturing process, controls, and stability of a pharmaceutical product.
