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Intricacies in the Approval of Radiopharmaceuticals – Regulatory Perspectives and the Way Forward


Affiliations
1 I. K. Gujral Punjab Technical University, Jalandhar - 144 603, India
2 National Institute of Pharmaceutical Education and Research, SAS Nagar - 160 062, India
3 Maharaja Ranjit Singh Punjab Technical University, Bathinda - 151 001, India
4 Shivalik College of Pharmacy, Nangal, Rupnagar - 140 126, India
5 Defence Food Research Laboratory, Siddartha Nagar, Mysuru - 570 011, India
 

Extensive research by the global scientific fraternity has led to the production of many radiopharmaceuticals of immense clinical importance. However, this increasing availability has not been matched by adequate regulatory action to back up the legal foundation for their commercial use. It is imperative for a radiopharmaceutical to have a seal of regulatory authority approval to qualify for human use. The present article highlights various regulatory requirements for approval of radio-pharmaceuticals in USA, Europe, and particularly India, which does not have guidelines for their approval, and intensifies the concern for a harmonized regulatory platform of global acceptance.

Keywords

Approval, Commercial Use, Guidelines, Radiopharmaceuticals, Regulatory Authority.
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  • Intricacies in the Approval of Radiopharmaceuticals – Regulatory Perspectives and the Way Forward

Abstract Views: 376  |  PDF Views: 112

Authors

Sandeep Sharma
I. K. Gujral Punjab Technical University, Jalandhar - 144 603, India
Sanyog Jain
National Institute of Pharmaceutical Education and Research, SAS Nagar - 160 062, India
Ashish Baldi
Maharaja Ranjit Singh Punjab Technical University, Bathinda - 151 001, India
Rajesh K. Singh
Shivalik College of Pharmacy, Nangal, Rupnagar - 140 126, India
Rakesh Kumar Sharma
Defence Food Research Laboratory, Siddartha Nagar, Mysuru - 570 011, India

Abstract


Extensive research by the global scientific fraternity has led to the production of many radiopharmaceuticals of immense clinical importance. However, this increasing availability has not been matched by adequate regulatory action to back up the legal foundation for their commercial use. It is imperative for a radiopharmaceutical to have a seal of regulatory authority approval to qualify for human use. The present article highlights various regulatory requirements for approval of radio-pharmaceuticals in USA, Europe, and particularly India, which does not have guidelines for their approval, and intensifies the concern for a harmonized regulatory platform of global acceptance.

Keywords


Approval, Commercial Use, Guidelines, Radiopharmaceuticals, Regulatory Authority.

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DOI: https://doi.org/10.18520/cs%2Fv116%2Fi1%2F47-55