Import of ROK medical products banned in China

A pharmaceutical company, Daewoong Pharmaceutical Co. Ltd, from Republic of Korea (ROK) has been banned the import of a set of its antibiotics injection products by China’s health regulator. This import ban has been issued as the company refused to accept spot checks of its manufactured products. Compliance with GMP standards is necessary to ensure the quality, safety and efficacy of the manufactured drugs.
China Food and Drug Administration (CFDA) has issued a notice ordering all the ports to curb the import of cefmetazole products manufactured by Daewoong Pharmaceutical Co. Ltd of ROK. The statement of CFDA also included that the body aimed at inspecting the manufacturing facilities of some finished imported goods that also included cefmetazole manufactured by Daewoong Pharmaceutical Co. ltd.

While this checking of manufacturing facilities was as per a prearranged schedule, the company refused to accept the checks. This led to CFDA’s decision of banning the cefmetazole manufacturing unit until CFDA felt confident that the production was in compliance with the standard good manufacturing practice (GMP) norms. This would be possible only after satisfactory inspection be means of spot checks.