5 June 2019
China’s New Authorisation Regime: A Boon to Medical Innovation in the Greater Bay Area
The rapid development of China’s innovative biomedicine industry in recent years has attracted a great deal of attention. Businesses originally involved in the supply of traditional Chinese medicines or Western pharmaceuticals are now venturing into the field in the hope of capturing some of this emerging opportunity. However, developing innovative medicines is not only a time-consuming process which can span many years from early research through clinical trials to production and marketing, but is also very costly.
An added difficulty is the constraints on growth caused by the intense global competition for the highest quality institutional resources and scientific research talent. To overcome these problems, pharmaceutical research and production companies operating in the Greater Bay Area (GBA) have suggested that mainland enterprises and Hong Kong industry players should take advantage of GBA initiatives designed to encourage collaboration and work closely together, using each other’s strengths and resources to expand into this emerging biomedicine market.
Among those calling for greater cooperation is Xin Rong, Deputy General Manager of Guangdong Sunho Pharmaceutical Co Ltd (Guangdong Sunho). In an interview for HKTDC Research, she argued that such a move would be mutually beneficial, saying: “Hong Kong has a large pool of top-tier scientific research talent in the biomedicine field. Given that fostering technological collaboration between Guangdong, Hong Kong and Macao is one of the GBA’s main policy priorities, mainland enterprises can step up their cooperation with Hong Kong’s biomedicine enterprises and tertiary institutions and boost each other’s competitiveness in the mainland market.
“Mainland industry players can address their shortcomings with the help of Hong Kong’s research achievements and technologies, while providing Hong Kong enterprises with commercialisation services such as clinical trials on the mainland and production support.”
Xin also pointed to the opportunities presenting themselves to businesses from the moves taken by the Chinese government to open up the process for regulating new drug products and approving them for the market. In 2016, the State Council promulgated the Pilot Programme of the Drug Marketing Authorisation Holder System, announcing that the new mechanism would be trialled in 10 provinces and municipalities - Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan.
The pilot programme allows pharmaceutical R&D institutes and scientific researchers, as well as qualified drug manufacturers, to act as drug registration applicants, submitting applications for clinical trials and marketing as drug registration applicants. Once they have received marketing authorisation and approval, they can be recognised as the Marketing Authorisation Holders (MAHs) of the concerned drug. The aim of the reform is to encourage innovation and improve the quality of drug products.
Xin reckons that the pilot programme will help rectify the problems caused by the prevailing drug marketing registration system, which stipulates that only drug manufacturers meeting the pharmaceutical GMP standards are eligible to apply for drug marketing registration. This has discouraged pharmaceutical R&D institutes from developing innovative medicines.
Under the pilot programme, however, R&D institutes and scientific researchers can obtain direct benefits from their research achievements. Xin explained that this change could have a profound impact by motivating scientific researchers to embark on the research and development of innovative medicines, particularly in developing new-generation biomedicines.
Xin’s company Guangdong Sunho, which is located in Zhongshan city in the GBA, accommodates four GMP facilities for production of freeze-dried and small-volume injection solutions, oncology drugs, small-volume injection solution for terminal sterilisation, and oral use preparations. Production lines for prefilled cartridge, fat emulsion and blow-fill-seal process are now being built. It has also started the certification processes of its production lines to the standards set out by the US’s Food and Drug Administration (FDA) and the European Union’s European Medicines Agency (EMA), aiming to help the company and its partners to make further inroads into overseas markets.
[Remark: For more information, please refer to HKTDC research article: Hong Kong Leading the Way in Greater Bay Area Biomedical Services Cooperation]
Business Advisory Unit
HKTDC Research Department
 HKTDC Research interviewed Guangdong Sunho in April 2019 in conjunction with the Department of Commerce of Guangdong Province.
 In accordance with the Decision of the Standing Committee of the National People’s Congress on Authorising the State Council to Conduct the Pilot Programme of the Drug Marketing Authorisation Holder System in Certain Areas and Related Issues, the State Council promulgated the Pilot Programme of the Drug Marketing Authorisation Holder System on 26 May 2016 with the original implementation period ending on 4 November 2018. Pursuant to the decision made at the Sixth Session of the Standing Committee of the 13th National People’s Congress, the pilot programme was extended for one year with effect from 5 November 2018 so as to better summarise the trial implementation result and align with the amendment of the Drug Administration Law of the People’s Republic of China.