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| BPOM to Accelerate Radiopharma Drug Certification to Enhance Cancer Treatment. |
PEWARTA.CO.ID - The National Food and Drug Authority (BPOM) is set to improve and expedite the certification process for radiopharmaceutical drugs, enhancing cancer care across the country. This move aims to streamline the Good Manufacturing Process (CPOB) certification for such drugs, which are vital in the fight against cancer.
Globally, cancer remains a significant health concern, with the International Research for Cancer indicating that at least 25 million people succumb to the disease each year. In Indonesia, the figure has reached 240,000 annual deaths, BPOM head Taruna Ikrar shared.
"In 2022, there were an additional 420 thousand (deaths) annually, which means that the mortality rate almost capped at 70 percent," Ikrar remarked during the inauguration of Kalbe Farma's radioisotope production facility on Tuesday.
Despite the availability of several cancer treatments, such as hormone therapy, chemotherapy, and surgeries, the results often fall short of expectations. According to Ikrar, radiotherapy offers a more targeted method to address difficult-to-treat cancers, making it a promising option in cancer treatment.
As the regulatory body responsible for drug oversight in Indonesia, BPOM has pledged to enhance the certification process for radiopharmaceuticals, aiming to provide faster access to these crucial drugs. Ikrar emphasized that BPOM would focus on reducing wait times for product distribution permits while adhering to the strictest standards of efficacy, quality, and safety. This ensures that only the highest-quality treatments reach patients.
"For example, a review that takes 300 work days can be cut down to just 120 working days and be made even shorter, depending on some needs," Ikrar elaborated.
He praised Kalbe Farma's efforts in establishing a radioisotope production facility, considering it a positive step toward developing Indonesia's radiopharmaceutical ecosystem. He believes that a well-developed ecosystem could help address the country's cancer burden and potentially contribute to global cancer treatment efforts.
Irawati Setiady, President Director of Kalbe Farma, also stressed the importance of the new facility, highlighting its role in manufacturing PET and CT scan machines locally. These machines are crucial in diagnosing and treating cancer in Indonesia.
"Currently, radiopharmaceuticals production facilities are very limited, whereas the needs are increasing," Setiady explained.
The limited availability of such facilities has led to extended waiting times for cancer diagnoses, pushing many patients to seek treatment abroad, she noted. Setiady also emphasized that the initiative aligns with the government's efforts toward health transformation, particularly in strengthening the country's resilience in medical device production.
