TY - JOUR
T1 - Harmonization of U.S., European Union, and Canadian First-in-human regulatory requirements for radiopharmaceuticals
T2 - Is this possible?
AU - Schwarz, Sally W.
AU - Decristoforo, Clemens
AU - Goodbody, Anne E.
AU - Singhal, Nikhita
AU - Saliba, Sarah
AU - Ruddock, Patrick S.
AU - Zukotynski, Katherine
AU - Ross, Andrew A.
N1 - Publisher Copyright:
COPYRIGHT © 2019 by the Society of Nuclear Medicine and Molecular Imaging.
PY - 2019/2/1
Y1 - 2019/2/1
N2 - In recent years, several new radiotracers and radionuclide therapies have been developed. There is a renaissance in nuclear medicine and molecular imaging today in terms of, for example, the ability to image and treat neuroendocrine and prostate malignancies. To be able to bring a new drug product from bench to bedside and assist patients while also ensuring patient safety, stringent regulations must be met. However, differences in regulatory requirements, often based on jurisdictional politics rather than scientific evidence, can hinder global cooperation, increase expense, and slow progress. In an effort to rise above these differences, nuclear medicine professional organizations, regulators, and international agencies have begun to identify commonalities in the regulations to achieve harmonization. Indeed, a more streamlined approach to radiopharmaceutical drug development across jurisdictions could be achieved through establishing harmonized requirements for preclinical studies and manufacturing standards. This paper provides an educational overview of the regulatory and submission requirements governing investigational radiopharmaceuticals for first-in-human radiopharmaceuticals across the European and North American continents. It is hoped that through ongoing collaboration, regulatory reform and harmonization can become a reality and speed access to the most up-to-date evidence-based patient care for all.
AB - In recent years, several new radiotracers and radionuclide therapies have been developed. There is a renaissance in nuclear medicine and molecular imaging today in terms of, for example, the ability to image and treat neuroendocrine and prostate malignancies. To be able to bring a new drug product from bench to bedside and assist patients while also ensuring patient safety, stringent regulations must be met. However, differences in regulatory requirements, often based on jurisdictional politics rather than scientific evidence, can hinder global cooperation, increase expense, and slow progress. In an effort to rise above these differences, nuclear medicine professional organizations, regulators, and international agencies have begun to identify commonalities in the regulations to achieve harmonization. Indeed, a more streamlined approach to radiopharmaceutical drug development across jurisdictions could be achieved through establishing harmonized requirements for preclinical studies and manufacturing standards. This paper provides an educational overview of the regulatory and submission requirements governing investigational radiopharmaceuticals for first-in-human radiopharmaceuticals across the European and North American continents. It is hoped that through ongoing collaboration, regulatory reform and harmonization can become a reality and speed access to the most up-to-date evidence-based patient care for all.
KW - EMA
KW - FDA
KW - First-in-man
KW - Health Canada
KW - Investigational new drug
KW - Radiopharmaceuticals
UR - http://www.scopus.com/inward/record.url?scp=85060952849&partnerID=8YFLogxK
U2 - 10.2967/jnumed.118.209460
DO - 10.2967/jnumed.118.209460
M3 - Article
C2 - 30262520
AN - SCOPUS:85060952849
VL - 60
SP - 158
EP - 166
JO - Journal of Nuclear Medicine
JF - Journal of Nuclear Medicine
SN - 0161-5505
IS - 2
ER -