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Imported item 10
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Imported item 12
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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.

M

Imported item 35

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK regulator responsible for medicines, medical devices and blood components for transfusion. Its work concerns their safety, quality and effectiveness. For research teams, its regulatory role is distinct from data protection supervision and the ethical review of research.

Key takeaways

  • The MHRA regulates medicines and medical devices in the UK.
  • The ICO and HRA perform different oversight functions.
  • Product regulation does not replace data protection assessment.

MHRA, ICO and HRA Compared

The MHRA’s published responsibilities include evaluating products, monitoring safety and maintaining relevant regulatory standards. Its Yellow Card scheme supports reporting of suspected medicine side effects and medical device problems. Research planning should identify the required route for the actual study, rather than assuming that every health research project follows the same medicines-trial process.

OrganisationPrincipal role relevant here
MHRAMedicines and medical device regulation and safety.
ICOInformation rights and data protection oversight.
HRAResearch ethics and related governance functions.

Why It Matters for Data Protection

The ICO covers UK data protection, while the HRA promotes ethical research and protects participants’ interests. Most HRA functions apply in England, with UK-wide coordination. As an operational recommendation, maintain a decision log separating product-regulatory permissions, ethics decisions and privacy arrangements. An approval letter in one area should not be used as evidence that every other requirement has been satisfied.

Hypothetical example: A sponsor preparing a UK medicinal-product trial creates separate workstreams for the regulatory application, research ethics review and study data flows. The privacy workstream recommends checking participant information, processor arrangements and overseas access before site activation rather than waiting for a regulator to request them.

Frequently Asked Questions

Is the MHRA the UK data protection authority?

No. That oversight belongs to the ICO.

Does MHRA authorisation replace ethics review?

No. Product-regulatory and ethics responsibilities are distinct.

Does a Yellow Card report prove causation?

No. The scheme accepts suspected adverse reactions or device problems, not only proven causal relationships.

Related reading: ICO, Yellow Card scheme.

For practical implementation, explore clinical operations and regulatory affairs support.

Updated: 27 October 2026