Source: Baidu

According to the document, pharmaceutical manufacturers are asked to self-inspect whether their production techniques for drugs approved for launch on the market are consistent with those approved by food and drug departments. This check should be finished before 1 Oct., 2016 and the results should be reported to provincial food and drug departments who will then be responsible for collating and reporting the results to the CFDA by 1 Nov., 2016.

From 1 Nov., 2016, the CFDA will assign experts to conduct unannounced inspections (random on-site checks, especially targeted at enterprises that have broken the GMP or have a bad production record) of pharmaceutical manufacturers. If the actual techniques being used are found to be other than those declared to food and drug departments, the products will be treated as counterfeit medicine and the involved producers will be punished in accordance with the Drug Administration Law.

Moreover, these changes in actual production require certification of their techniques and a supplementary application for alteration of the registered technique. If the changes are judged to have a negative influence on drug quality, producers should cease production at once and submit a supplementary application to modify their production technique.

Only once the CFDA has approved the modification can enterprises resume production. Specifically, for drugs in production, the certification and application need to be processed by 30 June, 2017 and for those in suspended production, done by 31 Dec., 2017. Production will have to be halted if these requirements are not met on time.

In recent years, some pharmaceutical producers have still been found to have applied production techniques without administrative approval or have changed their techniques without any certification or application as required by the CFDA. Therefore, the CFDA asked manufacturers to conduct self-inspection on production techniques in Aug., 2016.

Prior to this, in July 2015, the CFDA issued the Announcement on Self-inspection of Drug Clinical Trial Statistics and, in March 2016, the State Council released the Opinion on Consistency Evaluation of Quality and Efficacy of Generic Drugs. This demonstrates that China is strengthening regulation of the domestic pharmaceutical market, aiming to guarantee drug safety and efficacy during the production process.

In fact, modifying production techniques has become standard practice in the pharmaceutical industry. According to CCM's research, there is often a big difference between the actual production standards being used and those declared to food and drug departments. Declaring a high production standard can reduce the time it takes to obtain a production license, however when put into practice such standards are tough to meet.

"Pharmaceutical manufacturers have to alter the production techniques they are using so as to sustain their business, which will certainly raise operating costs. Of course, those failing to change production techniques will very likely be eliminated from the market," an industry insider commented to CCM.

This article comes from Amino Acids China E-News 1608, CCM

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Tag: pharmaceutical

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