Recently, the China Food and Drug Administration ("CFDA") has organized relevant authorities to draft the Provisions on Overseas Inspections of Drugs (Draft for Comment) (the "Draft for Comment"), which is hereby issued for public comments by September 24, 2017.
The Draft for Comment, comprised of five articles with a total of 34 articles, applies to inspections of the research, development and production performed at broad for drugs that have been or will be launched on the Chinese market. The Draft for Comment states that the risk evaluations should mainly take into account the registration evaluation and approval of drugs, routine regulation, import inspections, monitoring of adverse effects, complaints and reports, and other risk information, and pay particular attention to another seven factors, including the "possible bad records of the importer". According to the Draft for Comment, the assessment could conclude in an integrated way that the drugs concerned "meet certain requirements", "meet certain requirements after effective rectification", or "fail to meet certain requirements". With regard to varieties already on the Chinese market, the CFDA should, according to the integrated assessment outcome, take such measures to control risks as requesting an interview, ordering rectification within a prescribed period, issuing a warning letter, suspending the record-filing for the customs clearance of drug imports, supervising the withdrawal of products in question, ordering the suspension of sales and use, and refusing to approve an application for re-registration.