China tightens rule on imported drugs

29 February 2016

The Chinese Food and Drug Administration (CFDA) now requires all imported drugs to comply with the newest version of the China Pharmacopoeia (CP) released in 2015, reports The Pharma Letter’s local correspondent Wang Fangqing. Previously, such a requirement only targeted drugs manufactured inside mainland China.

According to the CFDA, imported drugs covered by the CP, which has 5,608 drug types, need to go through tests in China to get approval to be sold in China. For example, imported inactivated hepatitis A vaccines (HAV) have to be tested for in vitro relative potency. China currently imports two major HAV vaccines: Vacqta from Sanofi (Euronext: SAN) joint venture Sanofi Pasteur MSD, Merck, and Expaxal from Crucell Switzerland, now a subsidiary of Johnson & Johnson (NYSE: JNJ).

For the imported drugs that are not covered by the CP, they still have to comply with the CP’s general requirements. For example, there are requirements for tablets, capsules and injectables.

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