Improve the regulation policies and standards to promote a quality development of innovative radiopharmaceuticals industry

Novartis

Executive Summary

Nuclear technology, as a modern cutting-edge high technology, is widely applied across various sectors of the national economy. In healthcare, nuclear medicine, which uses radionuclide to diagnose, treat and research diseases, plays an irreplaceable role in the diagnosis, treatment and prognosis of various diseases. Radiopharmaceuticals, as a special category of drugs and a cornerstone of modern nuclear medicine, enable effective diagnosis and treatment for various diseases with the radiation emitted by the contained radioisotopes.

Clinical trials have shown that radioligand therapy benefits patients with gastroenteropancreatic neuroendocrine tumors and metastatic castration-resistant prostate cancer. Ongoing clinical research on more indications suggests that it shows promise in potentially treating other cancers, including brain malignant tumors (glioblastoma), breast cancer, lung cancer, and digestive tract tumors. The country attaches great importance to cancer prevention and treatment, and has set up the Cancer Prevention and Treatment Action in the special actions of the Healthy China Action (2019-2030). Radioligand therapy offers a promising opportunity to advance the Healthy China Initiatives.

Over the past decades, China has made significant strides in the research, development and clinical application of radiopharmaceuticals. Thanks to the release of supportive policies constantly in recent years, the industry has been developing fast. In October 2024, the China Atomic Energy Authority, along with eleven other ministries, issued the Three-year Action Plan for Quality Development of Nuclear Technology Application Industry (2024-2026), further boosting industry confidence. Despite advances in radiopharmaceuticals and growing clinical demand, China's pharmaceuticals industry faces several challenges: (a) improving the clinical application system of nuclear medicine and recognizing the technical service value of nuclear medicine departments, (b) balancing radiation safety regulations with practical clinical applications and transportation, (c) enhancing the specifications for new radionuclide radiopharmaceuticals and protection standards in medical institutions, and (d) clarifying policies and regulations for research, management, and approval of radiopharmaceuticals and their components.

The nuclear medicine industry has emerged as a key area for developing new quality productive forces. The government has already identified the radiopharmaceutical industry as one of the strategic emerging industries and foundations for quality development of China’s healthcare sector. In support of the accomplishment of these goals, Novartis would like to propose the below recommendations, to foster a sustainable environment that enables the development of radiopharmaceuticals industry, with all relevant stakeholders.

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