Life Sciences Blog

China’s new clinical trial regulations a win-win for all




Earlier this month, China took an axe to a swathe of red tape that has infuriated overseas drugmakers for years: the requirement for local clinical data as part of the drug approval process.

On 9 October, China’s State Council announced that data from overseas clinical trials can now be used for drug registrations in the country. This effectively spares pharmaceutical multinationals the expense of conducting local clinical trials in addition to their existing research – a requirement that typically delayed by several years access to the world’s second-largest pharma market.

Against the backdrop of rapidly-rising demand for innovative medicines, the State Council added that the new guidelines are aimed at ensuring that the drug review and approval process for new “urgently needed drugs” should “become faster”, particularly in severe life-threatening disease areas where there is a lack of effective treatments, or an urgent public health need.

According to the China Food and Drug Administration (CFDA), the new policy will reduce “unnecessary trials” and R&D costs. Until now, Phase III trials in China have typically required a minimum of 200–300 patients for chemical and biologic drugs respectively, with data from between six and 10 months of trials conducted in China. In addition, pharmaceutical multinationals were also required to complete Phase I clinical trials overseas, before receiving the go-ahead for clinical studies in China.

Overseas drugmakers are rejoicing at the announcement, heralding the new policy as a step towards not just reducing the drug approval backlog, but also closing the gap between China and the European Union, the United States and Japan.

The new policy "[paves] the way for China's integration into the system of multiregional clinical trials,” said Pfizer, which is expanding its presence in the country and expected to benefit from the new policy.

One key benefit is that China’s drug applications backlog – which soared to over 20,000 in 2015 – is expected to be (very) gradually reduced, granting swifter market access for foreign companies. In particular, pharma majors such as AstraZeneca (UK), Novartis (Switzerland), and Novo Nordisk (Denmark) are expected to benefit, and China’s drug imports might also see higher growth as a result.

AstraZeneca, for example, is preparing submission documents for chronic obstructive pulmonary disease (COPD) drug Bevespi Aerosphere combination, while, Boehringer Ingelheim plans to gain marketing approval for its lung cancer drug Giotrif in China.

The announcement was not unexpected. In March, the CFDA said it would allow drugmakers to apply directly for market authorisation in China following the completion of international multi-centre clinical trials, as part of ongoing efforts to shorten time to market for imported medicines. The CFDA has also proposed expedited reviews for clinical trial applications, which would allow sponsor companies to initiate clinical trials if they do not receive an answer from the CFDA within 60 days of submitting the application. The proposal’s 60-day window is still double that of the FDA, but nevertheless it reflects the CFDA’s urgency in cutting time to market.

Sophie Cairns is a Senior Analyst on the Life Sciences team at IHS Markit
Posted 23 October 2017

About The Author

Sophie Cairns is a Senior Analyst in the IHS Markit Life Sciences practice, covering the Asia-Pacific region. Sophie holds a Master of Science degree in Public Health from the London School of Hygiene and Tropical Medicine and prior to joining IHS Markit worked in several consulting and analytical roles, focusing in particular on pricing and reimbursement issues in China. Sophie also worked as a journalist for seven years, mostly as a foreign correspondent for Reuters newswire in Hong Kong, Shanghai and Paris. She is fluent in Chinese (Mandarin and Cantonese), French and German.