EMA issues new draft guideline: chemistry of active substances

December 18, 2024

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The European Medicines Agency (EMA) has released a draft guideline titled "Guideline on the Chemistry of Active Substances," which is open for public consultation until January 31, 2025.

This guideline aims to consolidate and update the requirements for the manufacture and control of both new and existing chemical active substances used in medicinal products. Once finalized, it will replace two existing documents: "Note for Guidance on Chemistry of New Active Substances" (CPMP/QWP/130/96, Rev 1) and "Chemistry of Active Substances" (3AQ5a).

The guideline outlines the necessary information for active substances, including:

- Structural Formula: Detailed information on the structural formula, encompassing relative and absolute stereochemistry, molecular formula, and relative molecular mass.

- Physicochemical Properties: Comprehensive data on properties such as solubility, acid dissociation constant, polymorphism, isomerism, partition coefficient, permeability, and hygroscopicity, all of which can influence pharmacological efficacy and toxicological safety.

- Analytical Procedures: Validation data for analytical methods used in controlling the active substance, ensuring precision and accuracy in quality assessment.

- Stability Data: Information on the stability of the active substance, including summaries, conclusions, and post-approval stability protocols.

The guideline also addresses considerations for starting materials of herbal origin and semi-synthetic substances, emphasizing the importance of risk assessments to ensure the safety and efficacy of medicinal products.

Stakeholders are encouraged to review the draft guideline and submit comments by the consultation deadline.