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.
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| Chen Yang Partner +86 10 5905 5600 cyang@sidley.com |
Sidley Global Life Sciences
Sidley Food, Drug and Medical Device Regulatory
Sidley Beijing Office
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