The China Food and Drug Administration (CFDA) published an announcement on February 16, 2016, explicitly requiring all imported drugs to comply with the China Pharmacopeia (ChP), recently amended in 2015. CFDA’s import drug control institutes will now conduct import testing on all imported drugs based on the ChP requirements.
Although it is a general principle that all drugs approved for market in China must comply with the ChP requirements, foreign drugs have generally followed the product-specific testing standards approved by foreign regulatory agencies that approved the drugs, as well as by the CFDA. These product-specific standards, however, may not be fully aligned with the ChP requirements in terms of testing method, assessment criteria, etc. Thus, to be released from import testing:
- Drugs that have been included in the ChP must now be in compliance with not only their specific registration standards but also the applicable ChP standards; and
- Drugs that have not been included in the ChP must now be in compliance with the relevant general requirements of the ChP.
As all foreign drugs imported to China must pass the import testing before customs clearance, foreign companies should expect enhanced import testing and potential hurdles, especially for drugs not included in the ChP. To ensure continuous product supply to the China market, companies should immediately assess and address any discrepancies between their own product standards and the ChP standards.
If you have any questions regarding this Sidley Update, please contact the Sidley lawyer with whom you usually work or
+86 10 5905 5600
To receive Sidley Updates, please subscribe at www.sidley.com/subscribe.
Sidley Austin provides this information as a service to clients and other friends for educational purposes only. It should not be construed or relied on as legal advice or to create a lawyer-client relationship.
Attorney Advertising - For purposes of compliance with New York State Bar rules, our headquarters are Sidley Austin LLP, 787 Seventh Avenue, New York, NY 10019, 212.839.5300; One South Dearborn, Chicago, IL 60603, 312.853.7000; and 1501 K Street, N.W., Washington, D.C. 20005, 202.736.8000.