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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).
Second Draft … was revised based on comments received on the first draft, which was published in February 2018. Both drafts note that the purpose of a stability study is to investigate the performance of primary plastic and rubber packaging materials with time , under defined temperature and humidity conditions. The study will provide a scientific basis for manufacturers of packaging materials to identify and recommend storage conditions and effective shelf life. The shelf life of the packaging materials from the pharmaceutical manufacturer’s perspective should start from the manufacture date of the packaging material, to the end of the drug product shelf life.
Key points of Second Draft … include:
Comments are being collected for Second Draft … – the timeline for official release is not known yet. The West Scientific Affairs team will remain vigilant on this, and other regulatory matters, in order to help customers effectively navigate the regulatory landscape.
<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.
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.
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.
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission. Defined as extractables and leachables, these assessments continue to evolve and expand due to consistently increasing regulatory agency expectations. Agency expectations require you to act sooner rather than later. Waiting until Phase III in drug development can lead to delays and additional costs due to poor assessments that are questioned by the reviewer, or incomplete submissions that require you to redo or execute additional work. You can start your Extractables and Leachables (E&L) assessment as soon as you have selected your packaging components.
It has been over a year since China Food and Drug Administration (CFDA) announced <em>Matters Concerning Bundling Review and Approval of Pharmaceutical Packaging Materials, Pharmaceutical Excipients and Drugs</em> (Document No.134 [2016]). As a result, the China pharmaceutical packaging industry is experiencing a revolution.
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