Case studies · Clinical trial sponsor, university hospital

Academic trial: placebo, analytical testing and QP release

A university hospital needed a medicinal product and a placebo for a trial in a new indication. We found the manufacturer, prepared the application, carried out the analytical testing and released the product. The trial was approved.

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At a glance

How can an academic sponsor obtain an IMP and matching placebo for a trial?

Client: Clinical trial sponsor, university hospital
Task: The academic sponsor wanted to investigate an authorised medicinal product in a clinical trial for a new indication.
Outcome: A pragmatic agreement was reached with the authority, and the clinical trial was approved and conducted.
What A&O took on: Regulatory Affairs QP Batch Release GMP and GxP Consulting & QA Support Analytical Services
Responsible: Dr. Olaf Mundszinger Qualified Person (QP) under § 14 AMG Dr. Emmanuel Bey Qualified Person (QP) under § 14 AMG Dr. Lenka Taylor Qualified Person (QP) under § 14 AMG Ute Hegener Information Officer under § 74a AMG

How it went

Starting point, approach, outcome.

Told plainly, in the order it actually happened.

01
Starting point

What the client came to us with. The academic sponsor wanted to investigate an authorised medicinal product in a clinical trial for a new indication. This required access to the medicinal product and a matching placebo, both manufactured in compliance with GMP. The sponsor was looking for a partner who could source the medicinal product and the placebo, ensure GMP-compliant manufacture and ultimately take care of the release. The sponsor also needed support in preparing and submitting the clinical trial application.
02
Approach

What we actually did. We identified a manufacturer for the authorised medicinal product and the matching placebo. We oversaw the GMP-compliant manufacture of the placebo and the investigational medicinal product in a non-EU country and qualified the manufacturers through audits. We were in contact with the competent authorities about approval of the clinical trial and prepared the IMPD and the clinical trial application. We handled the regulatory import of the products, including analytical testing, and finally released the investigational medicinal product for use in the trial.
03
Outcome

The outcome. A pragmatic agreement was reached with the authority, and the clinical trial was approved and conducted. GMP oversight, analytical testing, batch release and regulatory support came from a single provider.

Terms used in this case

Good Manufacturing Practice (GMP) Investigational Medicinal Product Dossier (IMPD)

Anonymised. Confidentiality is part of our business; we only name clients with their consent.

The legal framework

What the rules required in this case.

Regulation (EU) No 536/2014, Annex I, point 52

Where the investigational medicinal product is authorised, the current SmPC may be submitted as the IMPD; use outside the SmPC or after modification may require further data.

Regulation (EU) No 536/2014, Annex I, Section F

For an unauthorised investigational medicinal product made outside the EU, such as a placebo, the Article 61 authorisation and the Qualified Person's certification of equivalent GMP must be submitted.

§ 72(2a) AMG

Importing investigational medicinal products into Germany from outside the EU and EEA requires an import authorisation, granted under Article 61 of Regulation (EU) No 536/2014.

Regulation (EU) No 536/2014, Art. 62

The Qualified Person must ensure and certify that each batch of investigational medicinal product manufactured in or imported into the EU meets the requirements of Article 63.

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