One thing our China lawyers are often asked to assist with is product registration with China authorities to allow import and sale of pharmaceutical products in China. Often these foreign pharmaceutical companies manufacture their drugs in other countries so these must be properly registered before sales within China. Recent regulatory changes reflect the government’s efforts to centralize pharmaceutical product approvals.
The system used to require a clinical study and report to be completed and included in application documents submitted to a local approval authority for approval of the drug. Then, the local reviewing authority would perform an examination and make a whether to approve the drug registration.
Earlier this year the China Food and Drug Administration published a draft regulation revising application and review procedures for approval of new pharmaceutical products. According to the new regulation, starting December 01 2017, all applications for new drug approvals shall be submitted to the China Food and Drug Administration in Beijing.
If the current draft regulation is approved, all applications for approval of pharmaceutical products for import and sale into China will be handled from the new review office in Beijing. This review office is actually not far from the firm’s location in Beijing. As application document will need to be properly prepared and submitted in Chinese, foreign companies are recommended to utilize a local agent skilled in pharmaceutical product registrations to coordinate this process with the China Food and Drug Administration.