Guidance 20: Radiopharmaceuticals

Introduction

This information is intended for sponsors applying to the TGA to enter a radiopharmaceutical in the Australian Register of Therapeutic Goods (ARTG).

Contents

20.1 What are radiopharmaceuticals

Radiopharmaceuticals contain a radioactive component or are intended to be combined with a radioactive component before use. They comprise of:

• ready-for-use radiopharmaceuticals, including Positron Emission Tomography (PET) radiopharmaceuticals
• nonradioactive components (kits and chemical precursors, including those for PET) for combination with a radioactive component (e.g. eluate from a radionuclide generator or a cyclotron-produced radionuclide)
• radionuclide generators
• radionuclide precursors used for radiolabelling other substances before administration.

20.2 Product information for radiopharmaceuticals

Radiopharmaceuticals require a product information (PI) document. All changes to the PI must be consistent with the Minor variations to registered prescription medicines: chemical entities.

20.2.1 Units and calculations

Radioactivity should be expressed in SI units (becquerels).

Radiation dosimetry information should be based on the recommendations of the International Commission on Radiological Protection Publication 103 (ICRP 103).

The radiation doses provided in the radiation dosimetry table in the PI should be those delivered by administering the maximum recommended quantity of the radiopharmaceutical:

• Absorbed doses should be expressed in milligrays (mGy).
• The effective dose should be calculated using the weighting factors given by ICRP 103, and expressed in millisieverts (mSv).
• Where a radionuclidic impurity may make a significant contribution to the radiation dose, the additional contribution to the effective dose that results from the maximum allowable concentration of this impurity should be stated.
• If data based on ICRP 103 are not available at the time of application, radiation dosimetry estimates in the submission should be based on clinical trial information. When ICRP-based data become available, these should replace the clinical trial information in the PI.

20.2.2 Advice to users regarding disposal

Sponsors need to include a statement in the PI about waste disposal.

It is recommended that users are advised to observe the Code of practice for the disposal of radioactive wastes by the user. This code is published on the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) website as Radiation Health Series (RHS) No. 13.

20.3 Cyclotron-produced radiochemicals

Standard operating procedures (SOPs), together with an indication of how they have been validated, need to be included in an application to enter the medicine in the ARTG.

SOPs are required for:

• target preparation
• isotopic purity of target materials
• irradiation and processing.

It is not necessary to provide updated versions of these SOPs after the medicine has been entered in the ARTG.

Any changes to the method of manufacture are subject to the general and specific conditions outlined in Part 4 of Minor variations to registered prescription medicines: chemical entities.

20.4 Products based on monoclonal antibodies

Sponsors of new monoclonal antibody products that are intended to be labelled with ^99mTc or other radionuclides do not need to demonstrate that their product is compatible with all sources of the radionuclide available in Australia.

It is sufficient for regulatory purposes for the sponsor to:

• demonstrate compatibility with one approved source of the radionuclide available in Australia (if possible, the market leader)
• mention the compatible brand in the PI
• mention in the PI if the product is incompatible with the market leader in Australia.

Any additional compatibility claims in the PI should be supported by data.

20.4.1 Restrictions on time intervals

Sponsors should state in the PI any restrictions on the time interval since a ⁹⁹Mo/^99mTc generator has been previously eluted, including time after which sodium pertechnetate [^99mTc] should not be used for labelling.

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