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Drug Regulation

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

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Radiosynthesis, Quality Control, and Small Animal Positron Emission Tomography Imaging of 68Ga-Labelled Nano Molecules

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Published on: October 4, 2024

How Regulation 536/2014 Is Changing Academic Research with Therapeutic Radiopharmaceuticals: A Local Experience.

Valentina Di Iorio¹, Stefano Boschi², Erika Brugugnoli¹

¹IRCCS IRST Dino Amadori, Via Piero Maroncelli 40, 47014 Meldola, Italy.

Pharmaceuticals (Basel, Switzerland)

|November 27, 2025

Summary

New EU regulations for investigational therapeutic radiopharmaceuticals impact academic research. Adhering to Good Manufacturing Practice (GMP) requires investment but enhances trial quality and competitiveness.

Keywords:

GMP Regulation (EU) No. 536/2014 investigational therapeutic radiopharmaceuticals

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Area of Science:

Nuclear Medicine
Radiopharmaceutical Science
Regulatory Affairs

Background:

Academic research in therapeutic radiopharmaceuticals is evolving under new European Union (EU) regulations.
Regulation (EU) No. 536/2014 and Good Manufacturing Practice (GMP) guidelines significantly influence radiopharmaceutical development.
Local experience and analysis are crucial for understanding these impacts.

Purpose of the Study:

To examine the future of academic studies involving investigational therapeutic radiopharmaceuticals within the EU regulatory framework.
To discuss the impact of GMP requirements on radiopharmaceutical development.
To analyze the implications of Regulation 536/2014 on academic clinical trials.

Main Methods:

Analysis of the European regulatory context for investigational medicinal products (IMPs) and GMP for radiopharmaceuticals.
Review of position papers from scientific associations and EMA guidance.
Multidisciplinary team assessment of clinical implications and regulatory changes.

Main Results:

IRST has 20 years of experience, conducting 16 trials under the Directive and 5 under the new Regulation, enrolling over 1000 patients.
Successful transition involved staff training, establishing a Contract Research Organisation (CRO), budget planning, and utilizing a Contract Development and Manufacturing Organization (CDMO).
Regulatory constraints were transformed into opportunities for organizational enhancement, improved data reliability, and strengthened research capabilities.

Conclusions:

EU Regulation 536/2014 significantly impacts academic radiopharmaceutical research centers.
Adherence to GMP for therapeutic radiopharmaceuticals necessitates substantial investment in infrastructure and personnel.
Meeting GMP standards offers opportunities to improve clinical trial quality, reliability, and international competitiveness.