The People’s Government of Guangdong Province has unveiled an ambitious “Action Plan for Further Promoting the High Quality Development of the Biomedical Industry in Guangdong,” with the aim of expanding the province’s biopharmaceutical and health industry cluster to a scale exceeding RMB one trillion (USD 141.43 billion) by 2027. The plan specifically targets a scale of over RMB 500 billion (USD 70.72 billion) for pharmaceutical companies above a designated size, signaling a comprehensive support for the drugs and medical devices within the province.
In a bid to expedite the market launch of innovative drugs and devices, Guangdong will establish a joint service mechanism with the Greater Bay Area Center for Drug and Medical Device Evaluation and Inspection of the National Medical Products Administration. The plan envisions the approval of 2-5 innovative drugs and more than 5 innovative medical devices annually. The technical review timeline for Category II medical device registration will be slashed by an average of 50% compared to the statutory limit, and the initial registration review period will be condensed from 60 working days to 40 working days.
The government’s support extends to the digital transformation of biopharmaceutical companies across the entire lifecycle, from R&D to compliance. This includes targeted digital initiatives in chemical drugs, biopharmaceuticals, traditional Chinese medicine, and medical devices. For eligible technology renovation projects, the government will subsidize 20% to 30% of new equipment purchase costs, with a maximum reward of RMB 15 million (USD 2.12 million) per supported project.
The review timeline for traditional Chinese patent medicines and external simple preparations listed in Hong Kong and Macao will be reduced from 200 working days to 80 working days, and the approval and re-registration of changes post-listing will see a 50-working-day reduction, hastening their mainland market debut.
Furthermore, the plan includes cultivating medium and long-term investors and ‘patient capital,’ potentially establishing the Guangdong Province Biomedical Industry Investment Guidance Fund to provide investment support for promising enterprises and R&D pipelines, and increasing investments along the pharmaceutical industry chain.
Guangdong also aims to implement a “whitelist” system for cross-border data circulation for biopharmaceutical enterprises, ensuring secure and orderly data transfer in compliance with national laws and regulations.- Flcube.com
