Strengthening radiopharmaceutical product guidelines for enhanced safety and quality

20 August 2023

Highlights

Indonesia

Radiopharmaceuticals are radioactive substances used in nuclear medicine for diagnostic or therapeutic purposes, such as in cancer imaging and treatment. Radiopharmaceuticals should be regulated to guarantee their safety, quality, and efficacy. This ensures patient safety, quality control, radiation protection, traceability and fosters public confidence in the use of these important medical products in Indonesia.

The market for radiopharmaceuticals is experiencing growth, driven by technological advancements, a rise in cancer cases, and increasing usage in cardiology. Presently, around 44 radiopharmaceutical products are used in hospitals in Indonesia, but only 11 products have been approved by the Indonesian FDA. The other 33 unregistered products are supplied through the Special Access Scheme (SAS), a mechanism which enables expedited access to medical products not fully approved by the regulatory authority, often for patients with critical conditions and limited treatment options.

As with any medical product, ensuring the safety, quality, and efficacy of radiopharmaceutical products is a fundamental aspect, in line with the principles of Good Manufacturing Practice (GMP). However, beyond GMP requirements, specific quality aspects for radiopharmaceutical products such as radionuclide purity, radiochemical purity, radioactivity, sterility test, endotoxin/pyrogen test also require careful evaluation. Improvements can be made to the existing guidelines in Indonesia, including enhancing the quality and safety of radiopharmaceutical product packaging. Strengthening these guidelines will facilitate the development and utilization of radiopharmaceutical products in Indonesia.

To that end, WHO supported BPOM’s Directorate of Standardization of Drugs, Narcotics, Psychotropics, Precursors and Addictive Substances in the development of the radiopharmaceutical products guideline. The collaborative effort comprised a workshop, field visits to nuclear medicine facilities and a series of meetings for drafting the guideline.

Workshop (Credit: BPOM)

During the workshop, experts and participants from the International Atomic Energy Agency (IAEA), the Indonesian Nuclear Energy Regulatory Agency (BAPETEN), the National Nuclear Energy Agency of Indonesia (under National Research and Innovation Agency, BRIN), and Hasan Sadikin Hospital, gathered to strengthen regulators’ capacity in evaluating the quality and packaging of radiopharmaceutical products. The discussions covered topics such as safety standards for transportation of radioactive materials, radiopharmaceutical product quality standards in Indonesia and implementation of quality assurance in hospitals.

Field visits were conducted to observe nuclear medicine facilities at Hasan Sadikin Hospital and Santosa Hospital in Bandung. Participants from BPOM, BAPETEN and BRIN had the opportunity to examine radiopharmaceutical preparation rooms, which included laboratories, class C isolators, and biological safety cabinets (BSC), as well as follow the procurement and dispensing process. Both facilities made good efforts in obtaining and maintaining GMP certification while areas for improvement were identified and discussed.

Subsequently, experts from universities, BAPETEN, and hospitals actively participated in the guideline drafting process and provide technical inputs on radiopharmaceutical product safety, quality standards, business field classification (KLBI), prohibitions and restrictions (Lartas), and hospital implementation, including quality assessment and product packaging. The guideline drafting exercise also included a desk review and benchmarking with other regulatory agencies, such as the European Medicines Agency (EMA) and the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia.

Nuclear medicine facility (Credit: BPOM)

Radiopharmaceuticals, like any medical product, come with potential risks and threats that need to be carefully managed. These risks are typically associated with the use and handling of radioactive materials rather than the radiopharmaceutical itself. A robust regulatory framework, including strong guidelines for radiopharmaceutical products, serves to elevate healthcare standards and ensure that radiopharmaceutical products used in Indonesia meet the highest safety and quality requirements, ultimately benefiting the health and well-being of the general public.

The collaborative efforts of WHO and BPOM underscore their commitment to advancing proper health regulations by establishing comprehensive guidelines for radiopharmaceutical products. These efforts will continue to pave the way for safer and more effective medical practices in Indonesia. The new guideline for radiopharmaceutical products is expected to be released in early 2024.

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Written by Liyana Rakinaturia, National Professional Officer for Essential Medicines, WHO Indonesia

Media Contacts

Indonesia Communication Team

Email: wpinocomm@who.int