Non-interventional Studies

While Phase I–IV clinical studies examine the efficacy of a study product in a patient population according to clinical study protocol, non-interventional studies treat patients in daily clinical practice under real conditions.

 

Depending on the classification of the product, the non-interventional studies are regulated differently:

  • § Section 4 Paragraph 23 of the Medicinal Products Act (AMG)

"A clinical trial on human beings is any investigation on human subjects intended to investigate or verify the clinical or pharmacological effects of medicinal products, or to identify adverse reactions or to study the absorption, distribution, metabolism or excretion, with the aim of ascertaining the safety or efficacy of the medicinal product. Sentence 1 does not apply to non-interventional trials. A non-interventional trial is a study, in the context of which findings resulting from persons' treatment with medicinal products are analysed using epidemiological methods; the treatment, including the diagnosis and monitoring, shall not follow a predetermined trial protocol but shall result exclusively from current medical practice; in so far as a medicinal product requiring a marketing authorisation or a medicinal product requiring an authorisation pursuant to Section 21a sub-section 1 is concerned, this shall be conducted, moreover, according to the specifications regarding its use contained in the marketing authorisation or authorisation."

  • § Section 23b MPG

"§§ 20 to 23a shall not apply if a clinical trial is conducted with medical devices which may carry the CE marking in accordance with §§ 6 and 10, unless this trial has a different purpose for which the medical device is intended or additional invasive or other stressful investigations are performed.

  • § 15 of the medical professional code of conduct for physicians working in Germany (for all studies outside AMG and MDR).
  • Art. 83 and Annex XIV, Art.l 62–82 of EU MDR 2017/745).

 

For further information on how we can support your non-interventional study, please do not hesitate to contact us.

Post-Market Surveillance

Post-market surveillance (PMS) are studies designed to collect information on the use of authorised or registered medicinal products. Post-market surveillance studies are non-interventional studies within the meaning of Section 4 (23) sentence 3 of the Medicinal Produts Act (AMG).

PMS studies are not subject to approval, but are indicated. Pursuant to Section 67 Paragraph 6 (10) of the AMG, the competent higher federal authority makes the notifications and final reports submitted to it available to the public on the Internet.

Regulation (EU) 2017/745 on medical devices (EU MDR 2017/745) also regulates post-market clinical follow-up (PMCF, Annex XIV) and post-market surveillance (PMS, Article 83) for clinical evaluation (Annex XIV, Article 61) on clinical trials (Annex XIV, Articles 62–82). Clinical evidence for PMCF and PMS may be obtained through post-marketing surveillance in compliance with the rules.

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Post-Authorisation Efficacy Studies (PAES)

Post-authorisation efficacy studies (PAES) are performed to improve the understanding of the therapeutic efficacy and benefit-risk of a pharmaceutical with implications for more optimal use in everyday clinical practice. The design of the study should be ethically and scientifically justified.

The European Medicines Agency (EMA) has developed a scientific guideline describing how studies should be designed to support regulatory decision-making in the European Union.

 

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Post-Authorisation Safety Studies (PASS)

A post-authorisation safety study in accordance with Section 4(34) of the Medicinal Products Act is defined as "A post-authorisation safety study in the case of a medicinal product intended for use in humans is any assessment of an authorised medicinal product that is conducted to identify, characterise or quantify a safety risk, to confirm a medicinal product's safety profile or to measure the effectiveness of risk-management measures."

A post-authorisation safety study may be ordered or freely initiated, financed and carried out by the operator.

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