Current Science

Open Access Open Access  Restricted Access Subscription Access

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.
User
Notifications
Font Size

  • Ramberg-Laskaris, K. L., Quality control in the radiopharmacy. J. Nucl. Med. Technol., 1984, 12, 33-36.

  • Saha, G. B., Quality control of radiopharmaceuticals. In Fundamentals of Nuclear Pharmacy, Springer, 1998, vol. 6, pp. 148- 172.

  • Volkert, W. A., Goeckeler, W. F., Ehrhardt, G. J. and Ketring, A. R., Therapeutic radionuclides: production and decay property considerations. J. Nucl. Med., 1991, 32, 174-185.

  • Kocher, D. C., Radioactive Decay Data Tables, Oak Ridge National Lab, USA, 1981.

  • Manuel Arruebo, M., Vilaboa, N., Sáez-Gutierrez, B., Lambea, J., Tres, A., Valladares, M. and González-Fernández, A., Assessment of the evolution of cancer treatment therapies. Cancers (Basel), 2011, 3, 3279-3280.

  • Richter, W. F., Starke, V. and Whitby, B., The distribution pattern of radioactivity across different tissues in quantitative whole-body autoradiography (QWBA) studies. Eur. J. Pharm. Sci., 2006, 28, 155-165.

  • Wong, D. F., Potter, W. Z. and Brasic, J. R., Neuropsychopharmacology: The fifth generation of progress, Chapter 34. In Proof of Concept: Functional Models for Drug Development in Humans, Lippincott Williams and Wilkins, 2002, pp. 457-473.

  • Banerjee, S., Pillai, M. R. A. and Knapp, F. F., Lutetium-177 therapeutic radiopharmaceuticals: linking chemistry, radiochemistry, and practical applications. Chem. Rev., 2015, 115, 2934-2974.

  • Refining processes for the co-development of genome-based therapeutics and companion diagnostic tests: workshop summary. In Roundtable on Translating Genomic-Based Research for Health; Board on Health Sciences Policy, Institute of Medicine, The National Academies Press, Washington (DC), USA, 2014.

  • Nunn, A. D., The cost of developing imaging agents for routine clinical use. Invest. Radiol., 2006, 41, 206-212.

  • Hoffman, J. M., Gambhir, S. S. and Kelloff, G. J., Regulatory and reimbursement challenges for molecular imaging. Radiology, 2007, 245, 645-660.

  • Agdeppa, E. D. and Spilker, M. E., A review of imaging agent development. AAPS J., 2009, 11, 286-299.

  • Josephson, L. and Rudin, M., Barriers to clinical translation with diagnostic drugs. J. Nucl. Med., 2013, 54, 1-4.

  • Sharma, S., Baldi, A. and Sharma, R. K., Radiopharmaceuticals regulations on bioavailability and bioequivalence: present status and future requirements. Mod. Appl. Bioequiv. Bioavail., 2017, 1, 1-4.

  • Elsinga, P. et al., Guidance on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals. Eur. J. Nucl. Med. Mol. Imag., 2010, 37, 1049-1062.

  • Ziegler, S., Historical Role of the USP in Radiopharmaceuticals. In SNMMI Annual Meeting, Denver, Colorado, USA, 12 June 2017.

  • Food and Drug Administration Modernization Act (FDAMA), 1997; https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/fdama/default.htm (accessed on 1 July 2018).

  • Food and Drug Administration Amendments Act (FDAAA), 2007; https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm (accessed on 2 July 2018).

  • Notice of FDA exercise of enforcement discretion for PET drugs. June 2012; http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Manufacturing/UCM295267.pdf (accessed on 2 July 2018).

  • PET drugs - current good manufacturing practice (CGMP). US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2009.

  • PET drug applications - content and format for NDAs and ANDAs. US Department of Health and Human Services, Food and Drug Administration, CDER, USA, 2011.

  • Schwarz, S. W., Dick, D., VanBrocklin, H. F. and Hoffman, J. M., Regulatory requirements for PET drug production. J. Nucl. Med., 2014, 55, 1132-1137.

  • Hung, J. C., Bringing new PET drugs to clinical practice - a regulatory perspective. Theranostics, 2013, 3, 885-893.

  • Anjan, K. M., Sameeraja, N. H. and Murthy, P. N., Drug approval process - in United States of America, European Union and India: a review. Appl. Clini. Res. Clin. Trials Regul. Aff., 2014, 1, 13-22.

  • Raj, R. K., Pattanaik, P. and Roy, H., The dynamics of global Pharma regulatory affairs system. Indo. Am. J. Pharm. Sci., 2015, 1, 28-34.

  • Investigational new drug applications for positron emission tomography (PET) drugs. US Department of Health and Human Services, Food and Drug Administration, CDER, USA, 2012.

  • Lenaerts, K. and Desomer, M., Towards a hierarchy of legal acts in the European Union? Simplification of legal instruments and procedures. Euro Law J., 2005, 11, 744-765.

  • Scott, J. and Trubek, D. M., Mind the gap: law and new approaches to Governance in the European Union. Euro. Law J., 2002, 8, 1-18.

  • Salvodri, P. A., Radiopharmaceuticals, drug development and pharmaceuticals regulation in Europe. Curr. Radiopharm., 2008, 1, 7-11.

  • Directive 65/65/EEC, 26 January 1965, on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products. Official Journal of the European Communities; 369/65.

  • European Commission Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human. Offi. J. Eur. Union, 2001, 311, 67-128.

  • Hennings, G., Marketing authorizations of medicinal products in the European Union: past, present, and future. Ther. Innou. Regul. Sci., 2000, 34, 793-800.

  • Jürgen, F., Regulatory Europeanization, national autonomy and regulatory effectiveness: Marketing authorization for pharmaceuticals. MPIfG Discussion Paper, No. 02/6, 2002.

  • Kohler, M., Regulatory pathways in the European Union. mAbs, 2011, 3, 241-242.

  • Schmidt, S. K., Mutual recognition as a new mode of governance. J. Eur. Public Policy, 2007, 14, 667-681.

  • Chavan, P. N., Vijayan, S., Joshi, M. M., Godse, N., Marialouis, J. and Kasibhatta, R., Marketing authorization procedures in Europe: a regulatory perspective. Int. J. Pharm. Pharm. Sci. Res, 2011, 1, 13-19.

  • Makvana, P. and Maheshwari, D., Regulatory requirements for marketing authorization of generic parenteral product in European countries by decentralized procedure. J. Pharm. Sci. Biosci. Res., 2014, 4, 145-149.

  • EMA/821278/2015, Human Medicines Evaluation Division, European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure, October 2018.

  • Guideline on Radiopharmaceuticals, Committee for Human Medicinal Products (CHMP); European Medicine Agency, November 2008.

  • Nuclear Medicine Facilities, CODE No. AERB/RF-MED/SC-2 (Rev. 2), Government of India, 2011.

  • Recommendations of the SEC (radio-diagnostic) made in its special meeting held on 14 July 2017 at Central Drugs Standard Control Organization Headquarters, New Delhi, 2017.

  • Ministry of Health and Family Welfare, The Drugs and Cosmetics Act, 1940, Government of India.


Abstract Views: 361

PDF Views: 106




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

Abstract Views: 361  |  PDF Views: 106

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.

References





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