Registration of a radiopharmaceutical product in Singapore

A radiopharmaceutical drug is defined as a radioactive pharmaceutical agent that is used for diagnostic or therapeutic procedures. A radiopharmaceutical consists of a drug component and a radioactive component. Current registered radiopharmaceutical product in Singapore includes but not limited to : Sodium pertechnetate (^99mTc), Sodium Molybdate(99Mo), RADIUM-223 CHLORIDE, Sodium Iodide [I-131] .

Just like any other therapeutic products requires registration with the Health Sciences Authority before they can be supplied and marketed in Singapore. There is also a need to check out the appropriate Act and regulations on the import and supply of radiopharmaceutical products in licensed facilities with the National Environment Agency of Singapore. NEA’s Radiation Protection & Nuclear Science Department (RPNSD) is the national authority for radiation protection. It administers and enforces the Radiation Protection Act and Regulations through a system of licensing, notification, authorization, inspection, and enforcement.

The application category of a radiopharmaceutical drug falls under that of a New Drug Application. The available evaluation route will be Full route where no approval has been obtained from any regulatory agency in the world, abridged where approval has been obtained from at least one regulatory agency and verification where approval has been obtained from HSA’s reference agencies such as US FDA, EMA, Health Canada, UK MHRA and Australia TGA. The quality, safety and efficacy documents should be arranged in an ICH CTD format or an ASEAN CTD for submission and should be in English.

The requirements of a new drug application are listed in the table below:

Modules to be submitted as part of a product Dossier of a CTD format	New Drug Application
Module 1	Official certificates such as GMP and Proof of Approval such as CPP Official Letter of Appointments to Registrant, Manufacturers or Batch Releasers. Product Labelling Patent Declaration Worldwide registration status
Module 2	Introduction Quality Overall Summary for DS and DP Non-clinical Overview Clinical Overview Non-clinical Summary Clinical Summary
Module 3	3.2.S Drug Substance (3.2.S.1 to 3.2.S.7) 3.2.P Drug Product (3.2.P.1 to 3.2.P.8) 3.2.A Appendices 3.2.R. Regional information
Module 5	Tabular Listing of All Clinical Studies Clinical Study Reports List of Key Literature References Risk Management Plan

The application is required to be submitted online through a local entity established in Singapore via platform known as PRISM.

The typical processing timeline will take about 230 working days to get the license approved and the cost is around SGD$13,000. If you require support to register a radiopharmaceutical product in Singapore, get in touch with TRC.

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