The Chinese State Food and Drug Administration (SFDA) has recently issued a draft regulation “Measures on Managing Registration of Drugs,” which is currently soliciting public opinions on it. These measures outline new guidelines for evaluating drugs before marketing them in China. The SFDA would be required to check the safety, quality, and efficacy of drugs, running a cost-benefit analysis before making a decision on approving the marketing of a drug.
In addition, these Measures clarify the responsibilities of regulatory departments, increasing the role of provincial regulatory bodies in verifying application details and research conditions.
To ensure that examination and approval power is kept in check, specific procedures for drug registration, examination, verification, and approval for public supervision will be published.
Other planned regulations include stricter requirements for new product definition and increased checks that products follow manufacturers’ claims. Currently, even a change in form (such as from a tablet to a capsule) or a change in packaging can be defined as a new product registration, allowing companies to avoid price controls temporarily.
China has also planned reforms of the healthcare system, including a five-year plan to increase medical services and broaden healthcare networks. Under the 2007 government budget, China plans to spend over $3.5 billion on healthcare, which would be an increase of almost 90% compared to 2006.