This transformation is the result of a change in China's innovation ecosystem including unprecedented drug regulatory reforms. In 2015, China began rolling out a series of reforms, including changes to the new drug review and approval system, the generic drug quality and efficacy consistency evaluation and the volume-based tendering policy in order to shorten the clinical trial process, speed up new drug registrations and encourage innovation. In 2017, China became a full member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, an organization that standardizes global drug regulations [1].

Hsmap, a medical innovation and entrepreneurship big data platform based in Hangzhou, Zhejiang province, said in a recent report that in 2016, investigational new drug (IND) applications and new drug applications (NDAs) for Class 1 new chemical drugs (or those that have never been marketed in China or overseas) from domestic developers were 220 and 5, respectively, while in 2019, the two figures surged to 381 and 19. From 1 January to 20 May 2020, INDs and NDAs from domestic companies were 183 and 6, respectively, despite the impact of COVID-19.

China has also recently made moves to make some drugs approved abroad more accessible at home. China’s Center for Drug Evaluation (CDE) published a notice in October 2020 stating that it will consider adding clinical trial exemptions for medicines that are not yet available domestically but have been proved to be safe and effective in overseas markets. The notice seeks to address the urgent need for certain medications in China including for cancer and rare diseases. The notice also states that for drugs already accessible in China, when new usage techniques or administration routes are approved overseas, Chinese drug regulators may consider exempting them from further clinical trials depending on the clinical trial data. However, for generic versions of drugs accessible abroad but not domestically, new clinical trials may be necessary in China if the complete clinical trial data of the corresponding brand-name drug cannot be obtained.

‘That means there’s no good news for generic drugs in this document, which mostly stands to benefit innovative (brand-name) drugs’, said He Xiaobing, CEO of Beijing Memorial Pharmaceutical.

This announcement follows a major policy change in October 2017, which instituted an approval procedure of foreign drugs and medical equipment deemed to be urgently needed in the domestic market. The policy stated that, for the first time, China’s drug regulators could consider overseas clinical trial data when granting new approvals. Before this, Chinese authorities took at least six years to approve drugs that were already accessible abroad, according to the state-run People’s Daily newspaper.

‘The purpose of this move is to avoid repeated tests, bring down the cost of research, and improve efficiency in making these new drugs accessible to Chinese patients’, an official with the country’s drug regulator explained at the time.

Since then, the number of new drug approvals has increased dramatically. In 2018 and 2019, China approved 61 and 58 imported drugs, respectively, including new uses for previously approved imported drugs, compared with just 13 in 2016.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. China adopts ICH guidelines and collaborates with UK [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 20]. Available from: www.gabionline.net/Guidelines/China-adopts-ICH-guidelines-and-collaborates-with-UK

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