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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If you have any specific regulatory questions pertaining to entering the Singapore market or require assistance with pharma regulatory services and medical product registration, feel free to reach out. Your success in the pharmaceutical industry starts with us!

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