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In China, the industrial and regulatory landscape has been evolving rapidly – and in particular as it relates to generic drug products. In 2015, the China State Council announced Opinions on Reforming the Review and Approval System for Drugs and Medical Devices (No. 44). At this same time, a series of reforms were announced by the National Drug Administration of China (formerly the China Food and Drug Administration, CFDA) to upgrade the pharmaceutical industry by raising marketed products to international standards in terms of quality, safety and efficacy.
The Generic Consistency Evaluation (GCE) was one of these reforms. Historically, generic drugs only needed to demonstrate conformity with the quality standards in China; but they were not deemed equivalent to innovator drugs. In 2017, CFDA solicited public comments regarding Relevant Policies on Encouraging Drug and Medical Device Innovation and Implementing Life-cycle Management (Draft for Public Comment) (2017 No. 54). In this draft, producers of injectable generic drugs shall need to conduct re-evaluation on quality, safety and efficacy.
In 2017, China CDE (Center for Drug Evaluation) published Draft on Technical Requirements for Consistency in Evaluation of Marketed Generic Chemical Drugs (Injections). In this draft, the technical requirements of the evaluation include:
In this same draft, it was stated that the compatibility between drug product and the primary packaging components needs to be considered, and appropriate studies (mainly focused on extractables and leachables) must be conducted according to relevant guidelines released by China CDE. It is also suggested that during stability studies, container closure integrity tests be performed in lieu of sterility tests.
With these GCE policies, the requirements on primary packaging materials are no longer limited to meeting the quality standard, but also meeting fit for use purpose – providing needed protection, compatibility, safety, and performance. The West Scientific Affairs and Technical Customer Support teams have been following these changes closely, and are prepared to help customers navigate these changes and select the right components for use with generic drug products. Contact our Technical Customer Support team for more information.
With the continuous progress in medical science and technology, drug evaluation criteria in China are also changing and improving. In the past, drug evaluation criteria did not require generic drugs to have the consistent quality and efficacy of innovator drugs; so some had a gap in efficacy. Since 2015, the National Medical Products Administration of China (NMPA), formerly the China Food and Drug Administration (CFDA), rolled out the Generic Quality and Efficacy Consistency Evaluation (GQEC) to improve the quality and efficacy of generic drugs. Generic drugs whose quality and efficacy are deemed equivalent to innovator drugs will enjoy preferential treatment in public hospitals and prescriptions.
The regulatory landscape in China continues to evolve and become more stringent. In December 2018, the Chinese Pharmacopoeia Commission (ChPC) published: Second Draft for Comments on Guideline for Stability Study of Plastic and Rubber Pharmaceutical Packaging Materials. This guideline comprises part of the results of a research project organized by ChPC in 2016 and is one of the actions taken by National Drug Administration of China (formerly the China Food and Drug Administration, CFDA) to support the previously announced Opinions on Reforming the Review and Approval System for Drugs and Medical Devices (No. 44).
As China has become the fastest-growing market in generic drugs, China Food and Drug Administration (CFDA) is paying more attention to drug quality and setting a higher standard for pharmaceutical packaging. Compatibility of the drug with the packaging materials is one critical focus area.</br>
<p style="margin: 0in 0in 10pt;">The new regulation “Bundling Review and Approval of Packaging and Excipients with Drug Products” announced by the China Federal Drug Administration (CFDA) on August 10, 2016, has generated both interest and concern. While the CFDA has published several related guidelines in an effort to address questions, many still persist. </p>
<br />In 2016, the China Federal Drug Administration (CFDA) made two announcements regarding packaging of parenteral drug products. Per these announcements, stability studies of packaging materials should refer to protection, compatibility, safety and functionality properties.
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