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21 CFR Part 11
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Term of the Day

Natural history study

A natural history study is a preplanned observational study intended to track the course of a disease over time, identifying demographic, genetic, environmental and other variables that correlate with its development and outcomes in the absence of intervention, or under standard of care. Designs may be retrospective (chart review of existing records) or prospective (longitudinal follow-up of a cohort or registry).

Natural history data is particularly important in rare and paediatric diseases, where randomised placebo-controlled trials may be infeasible or unethical. The FDA (guidance on rare disease natural history studies, 2019) and the EMA accept well-designed natural history studies to define endpoints and biomarkers, identify patient subgroups, estimate sample sizes and, in some cases, serve as external or historical control arms for single-arm trials supporting orphan products.

Because they are non-interventional, natural history studies fall outside the CTR and are governed by national law (for example France's MR-003 or MR-004 reference methodologies) and by the GDPR. They typically involve secondary use of medical records, long-term follow-up, genetic data and small populations in which anonymisation is rarely achievable, so pseudonymisation, a DPIA and a robust research legal basis under Art. 9(2)(j) are essential. Registries maintained by patient organisations or academic consortia raise additional questions of joint controllership and data access governance.

C

Chemistry, Manufacturing and Controls (CMC)

Chemistry, Manufacturing and Controls (CMC) designates the body of information describing how a drug substance and drug product are made, characterised and controlled to ensure consistent quality. It forms Module 3 (Quality) of the Common Technical Document (CTD) and the quality part of an Investigational Medicinal Product Dossier or IND.

CMC content includes the chemical or biological characterisation of the active substance, the manufacturing process and its controls, specifications and analytical methods, reference standards, container closure systems, and stability data supporting shelf life. Requirements scale with development: a Phase I dossier is lighter than a marketing authorisation application, and CMC changes after approval must be managed through variation procedures.

CMC data is mostly technical and commercial rather than personal, but it is frequently classified as a trade secret and is a prime target for industrial espionage. It therefore sits at the heart of a life sciences company's cybersecurity programme and is protected under ISO 27001 information classification rules, even where the GDPR does not apply.

Is CMC documentation only a description of the manufacturing process?

No. CMC also covers how the substance and product are characterised and controlled, including specifications, analytical methods and stability information. Its purpose is to explain and support product quality. When organising a development dossier, keep manufacturing descriptions aligned with the controls and evidence used to justify the proposed product.