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Regulatory Focus™ > News Articles > WHO Seeks Additional Birth Control API Manufacturers as US FDA Bans China Site

WHO Seeks Additional Birth Control API Manufacturers as US FDA Bans China Site

Posted 12 April 2017 | By Zachary Brennan 

WHO Seeks Additional Birth Control API Manufacturers as US FDA Bans China Site

A Chinese manufacturer of the active pharmaceutical ingredient (API) for the birth control drug levonorgestrel has been placed on the US Food and Drug Administration’s (FDA) import alert list, causing the World Health Organization (WHO) to scramble to find a replacement.

"At the moment, there is no alternative levonorgestrel API which has been prequalified," WHO said Wednesday. When an API is prequalified by WHO, it can be used for the manufacture of finished pharmaceutical products (FPPs) to be procured by UN agencies, such as UNICEF.

WHO is requesting that FPP manufacturers of prequalified products that use levonorgestrel manufactured by the Hebei, China-based firm, known as Qinhuangdao Zizhu Pharmaceutical, take additional measures "such as comprehensive testing upon receipt to help ensure that the quality of all batches of levonorgestrel is assured.

"Until further notice, procurement agencies may continue to procure FPPs that contain API produced at Qinhuangdao Zizhu Pharmaceutical," WHO said in a statement, noting that to date, it "has not received any reports of quality issues on levonorgestrel tablets from the market."


On 8 March, Qinhuangdao was placed on import alert by FDA after an inspection found failures in the level of adherence to current good manufacturing practice (cGMP) for APIs. In particular, WHO said, the FDA inspection team "discovered a breach of data integrity related to testing in the Quality Control laboratory."

WHO’s Prequalification Team previously inspected Qinhuangdao in October 2015 for levonorgestrel, mifepristone and ethinylestradiol APIs, concluding with five major deficiencies, including data integrity issues, and several minor deficiencies. The manufacturer provided corrective and preventive actions (CAPAs) for all deficiencies and the inspection was closed as compliant, WHO said, noting that it has prequalified two FPPs for which the inspected Qinhuangdao is listed as the levonorgestrel supplier.

WHO also said it is planning to conduct an on-site inspection of Qinhuangdao and will continue to provide updates.


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