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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.
To implement the GQEC policy, in 2017, NMPA Center for Drug Evaluation (CDE) published The Technical Requirements for Consistency in Evaluation of Marketed Generic Chemical Drugs (Injections) (Exposure Draft)1. This document is used for the re-evaluation of generics which have not been reviewed and approved in accordance with the principle of consistent quality and efficacy.
On October 15, 2019, NMPA issued The Technical Requirements for Consistency in Evaluation of Quality and Efficacy of Generic Chemical Injections (Exposure Draft)2. This is applicable to all generic drugs, marking the full launch of consistency evaluation in China. This draft clarifies the requirements on the reference preparation, drug formulation, quality control of API, excipients and packaging materials, study of drug quality and control, as well as stability study.
The consistency evaluation stipulates the following requirements on packaging materials:
These requirements encourage pharmaceutical companies to conduct more comprehensive study on packaging materials, production process, and drug products, so as to ensure that the quality and efficacy of generic drugs are consistent with that of innovator drugs, and ultimately to assure the safety of drugs intended for use by the public. The West Scientific Affairs team will continue to focus on monitoring and understanding the dynamic regulatory landscape and help customers navigate these changes.
In addition, West is introducing a new product in April in China, which would support customers in the generics space in meeting the stringent requirements of GQCE. To learn more, kindly contact an Account Manager or the Technical Customer Support team
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.
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.
Effective change control systems are important for pharmaceutical packaging materials – especially those in direct contact with drugs. This topic has high visibility in the China pharmaceutical packaging industry as a new change control strategy for pharmaceutical packaging materials is coming.
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).
Extractables and leachables (E&L) remain as one of the hottest topics in China – a topic to which West makes a strong commitment – in order to anticipate and address ever-changing regulatory and technical requirements. As part of this commitment, Lynn Yao, Scientific Affairs Manager at West, presented <em>Challenges of E&L Study Under Changing Regulatory Environment</em> at the second-annual <span style="text-decoration: underline;">Extractables and Leachables China</span>, hosted by Smithers Rapra, September 2019 in Shanghai. This event assembled local stakeholders and experts for two days of presentations, training, and discussion on the China regulatory landscape, testing methods, and technical advances.
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