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Imported item 10
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Imported item 11
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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.

S

Imported item 11

Swissmedic is Switzerland’s authority for the authorisation and supervision of therapeutic products, including medicines and medical devices. Its work covers relevant clinical trials, product authorisations, inspections and market surveillance. Sponsors planning Swiss research should distinguish this product-regulatory role from ethics review and from oversight of personal-data processing.

Key takeaways

  • Swissmedic supervises therapeutic products, while the competent ethics committee has a separate role in assessing the clinical research project.
  • For category B and C medicinal-product trials, Swissmedic describes separate approvals from Swissmedic and the responsible ethics committee.
  • A Swissmedic authorisation does not remove the need to assess applicable Swiss data-protection requirements and research-data safeguards separately.

Swiss Research Oversight

Body or frameworkMain question
SwissmedicAre applicable therapeutic-product requirements met?
Competent ethics committeeIs the research acceptable within its statutory remit?
Data-protection frameworkHow are personal data processed and safeguarded?

Swissmedic describes its responsibilities across the therapeutic-product lifecycle. Its medicinal-product application guidance explains that category B and C trials require both approvals before starting. Category A medicinal-product trials are exempt from Swissmedic authorisation under that route; this is not an exemption from ethics requirements.

The route for a medical-device investigation is not necessarily the same as the medicinal-product route. Operationally, classify the product and study first, then build an approvals matrix using the current Swissmedic and ethics guidance.

Why It Matters for Data Protection

We recommend keeping regulatory submissions, participant information and the data-flow map aligned. Specify the records held by Swiss sites, data sent to foreign sponsors or vendors, access arrangements and retention responsibilities.

For example, consider a hypothetical international sponsor adding a Swiss site to an existing EU trial. Do not assume that an EU submission settles Swiss approvals or that EU privacy documentation needs no local review. Assign owners for both workstreams before site activation.

Frequently Asked Questions

Is Swissmedic the Swiss data-protection authority?

No. Swissmedic’s remit concerns therapeutic products; data-protection oversight is separate.

Does every trial need Swissmedic approval?

No. Requirements depend on the type and category of research.

Does ethics approval replace Swissmedic approval?

Not when both approvals are required for the study.

Related: Swiss FADP; EMA; Swiss privacy support.

Updated: 27 October 2026