It is hereby announced that the China Food and Drug Administration (CFDA) has recently organized an on-site inspection on the bacterial lysates capsules from OM Pharma SA in Switzerland (Trade Name: Broncho-Vaxom). During the inspection, it is found that the company has failed to declare the fermentation process change, fermentation conditions change and mixed process change of pyrolysis steps of this variety in accordance with Attachment 4 of the Provision for Drug Registration , which is inconformity with provisions in Article 184 of Good Manufacturing Practice and violates provisions in Article 9 of the Drug Administration Law of the PRC and the second paragraph of Article 84 of the Provision for Drug Registration . The CFDA hereby decides to ban the importation of bacterial lysates capsules from OM Pharma SA in Switzerland and request the Food and Drug Administration at each port to stop the import customs clearance of bacterial lysates capsules from OM Pharma SA.

It is hereby announced.

China Food and Drug Administration

March 13, 2017