Special registration rules to speed approval and encourage innovation


Hepeng Jia/Beijing, China

China is to speed up the approval of groundbreaking new drugs in an effort to encourage innovation in its pharmaceutical sector, a State Food and Drug Administration (SFDA) official has revealed.

’Our agency will soon release special drug registration rules, which are expected to accelerate the registration process for really innovative drugs,’ Yang Zhimin, a drug evaluator at the SFDA’s Centre for Drug Evaluation told delegates the ’Impact China’ international pharmaceutical summit on 5 May.

Her message comes amidst complaints from pharmaceutical firms and contract research organisations (CROs) that sluggish review procedures are hampering their attempts to start clinical trials in the country.

’In the US, we find out whether we have permission for clinical trial in just one month. But in China, the wait can be over six months,’ says Chen Zhengming, vice president of New Jersey-based biotech DOV Pharmaceutical.

According to Yang, however, these delays are partly due to the failure of drug companies to provide the regulator with all the necessary paperwork. In addition, she says that despite an increase in the number of reviewers from 54 in 1999 to 114 in 2007, her centre remains seriously understaffed.

The new rules will allow the centre to focus its resources on the most innovative drugs. Drug developers will be offered help to ensure they submit all the documents necessary for speedy approval.

The SFDA originally signalled its willingness to fast track approval for particularly novel drugs and treatments for key diseases such as HIV/AIDS in registration guidelines released in July 2007. But details of the scheme have been lacking until now.

Yang says that the special registration rules will set out criteria to classify innovative drugs and distinguish, for example, between meaningful modifications to the structure of a compound and simple changes to the dosage.

’We will not simply pursue faster review of drugs, but strike a balance between speed and their benefits and uncertainties,’ she told Chemistry World.

Su Ling, Wyeth’s vice president for Asia Pacific clinical research and development, welcomes the moves to prioritise innovative drugs but believes further reforms are needed to really speed up approvals.

’For example, SFDA should further simplify the procedures for generics, so as to free up more reviewing resources for innovative medicines,’ he says.