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Same-Day Analysis

China to reform drug approval system to expedite authorisation of innovative drugs

Published: 18 August 2015

China's State Council has issued new drug review guidelines to clear the China Food and Drug Administration's backlog of drug approvals, expedite approval of innovative medicines, and relax Chinese clinical trial regulations.

IHS Life Sciences perspective



China's State Council has issued new guidelines to expedite drug approvals for innovative drugs.


Under the new guidelines, companies will be allowed to conduct clinical trials in China, simultaneously with clinical studies elsewhere in the world. In addition, firms can apply to have the approval of their drug expedited where it targets certain diseases and meets set pricing stipulations. The CFDA has also been tasked with removing its backlog by the end of 2016.


With the CFDA facing a backlog of 21,000 pending drug applications, the ability of the regulator to meet its new targets seems somewhat ambitious. However, the new guidelines may be aimed at appeasing industry concerns over lengthy approval times and potential public anger over inaccessibility to treatments that their peers in other countries do not face.

The Chinese State Council has issued guidelines, cited by Bloomberg, to help accelerate drug approvals in China, thereby potentially easing challenges many multinational companies have faced in driving market access.

One of the policies to be introduced will enable pharmaceutical companies to apply for expedited approval of innovative drugs targeting cancer, major infectious diseases (including HIV), and rare diseases. Companies will however only be allowed to submit applications for expedited review where these drugs are not to be marketed in China at a price higher than originator countries, or comparable markets (it remains unclear which comparable markets will be applied). The government also seeks to clear the China Food and Drug Administration (CFDA)'s backlog of pending drug applications by the end of 2016.

At present, companies are able to import medicines into China, to conduct the clinical trials necessary for approval in the country, only after the drugs are approved in another country. Under the new regulations, international companies will now be permitted to use clinical trial data from studies conducted abroad to support importation as well as trials carried out simultaneously in China and foreign countries.

Outlook and implications

Obtaining approval in China has become increasingly challenging, with Johnson & Johnson (J&J, US)'s chief scientific officer Paul Stoffel, in an interview with Bloomberg in January, stating that gaining marketing approval in the country could take up to seven years, owing to the time taken for regulators to review an application. Indeed, the scale of the backlog is substantial. Wu Zhen, the vice-minister of the CFDA, reported that the organisation faces a backlog of 21,000 applications and has a staff of only 120 people.

Without a sizeable investment in staff levels to allow the backlog to be cleared and applications to be prioritised by 2017, it remains unclear if these aspirations can be met. Importantly, this investment in staffing levels would need to come at a time when the Chinese government is facing deterioration of the Chinese economy and therefore its willingness to invest in large projects such as this may be reduced. Adding staff could however be funded through an increase in registration fees, and indeed this may be the reason the CFDA increased registration fees in June (see China: 3 June 2015: China sharply raises registration fees for medicines and devices).

Although challenging to fulfil, the guidelines are meant to reassure international pharmaceutical companies that the government remains keen to retain their investment and involvement in the country. This is especially so following high-profile comments from a number of international pharmaceutical companies suggesting that their sales in China were declining due to increased generics competition, a slowdown in the Chinese economy reducing patients' ability to purchase drugs out-of-pocket (OOP), government efforts to reduce healthcare expenditure, and the negative impact of historic bribery investigations (see China: 7 August 2015: Novo Nordisk CEO warns of slowdown in Chinese pharma market).

The government may also consider it necessary to expedite drug approvals to provide Chinese patients with access to innovative medicines in line with other countries around the world. This may be based on the assumption that patients, who through the internet are increasingly aware of treatment options elsewhere in the world, could become angry if they feel they are being denied access to drugs. This anger would be especially difficult for the government to face, as it is held responsible for delays in access to the newest medicines and therefore would feel the brunt of public discontent.

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