China tightens controls on imported drugs
October 11, 2012 | BY
clpstaff &clp articlesNew Measures will force foreign drug makers to submit detailed reports in Chinese and open their manufacturing sites to inspectors. The penalties for non-compliance are harsh
China's State Food and Drug Administration (SFDA) is tightening up its supervision over imported drugs by carrying out overseas inspections of manufacturing sites. Foreign drug makers will have to submit reports of import, sales and production over the past three years and comply with the procedural requirements.
“Noncompliance could result in potential legal risks like the halting of the importation of drugs, recalling drugs from within China and the suspension of the registration or approval of new drugs,” said Henry Chen of MWE China Law Offices.
The Notice for Soliciting Public Opinion on The Administrative Measures for Inspection of Overseas Drug Manufacturers (关于《境外药品生产企业检查管理办法》征求意见的通知) came out on August 8 and the public consultation period ended on October 8. The Notice is the first time that the SFDA has considered imposing regulations on overseas good manufacturing practice (GMP) inspection since its experimental on-site inspections last November.
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