China tightens controls on imported drugs
October 11, 2012 | BY
clpstaff &clp articles &New 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.
Foreign pharmaceutical companies will have to watch out for compliance risks. In addition to new obligations imposed, the draft also proposes a number of penalties for noncompliance.
According to figures published by China Pharmaceutical News (an official newspaper run by the SFDA) in September this year, the Administration has more than 860 GMP inspectors. Under the draft proposal, the overseas inspection team will consist of between two and five inspectors.
The overseas inspection work is likely to place additional pressure on the SFDA, which is seen as short of staff and experience. Last November, SFDA sent 33 GMP inspectors to seven large non-Chinese pharmaceutical companies for experimental inspections.
“I think that it would be more cost effective to outsource the inspection work to local professional bodies or investigation agencies,” said Chen.
The SFDA is able to request inspections at its own discretion and is expected to do so regularly.
Under the draft guidance, foreign drug manufacturers who have obtained SFDA licences are required to submit import reports detailing quantity, port inspection, adverse reactions, complaints and recalls during the past three years.
Whether importation and sales were suspended due to quality issues in other countries must also be disclosed to the SFDA.
A master file that complies with the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) format is also required for GMP inspection. It must provide details of the manufacturer, distribution, audits and quality control system.
However, all the documentation needs to be in Chinese. “Pharmaceutical and life science is a highly specialised area. Multinational companies will have to incur extra costs to make sure their documentation in Chinese is of satisfactory quality,” said Chen.
The newly revised GMP rules came into force in March 2011. These rules have improved its practice and enabled it to reach international standards. China is seeking to join PIC/S, which is an important gauge to build up the legitimacy of its overseas inspectorate.
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