Generic Drugs in China – Understanding the Regulatory Landscape

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:

1. The primary packaging materials should meet the pharmaceutical packaging materials standards issued by the NMPA or relevant requirements in USP, Ph. Eur, or JP.
2. The depyrogenation validation for primary packaging materials should be performed, or alternatively, its relevant certification issued by supplier.
3. The packaging system shall be verified for container closure integrity; physical analysis techniques could be used when the test method shall be properly validated.
4. Compatibility studies should be carried out in accordance with the relevant guidelines published by CDE.
5. The quality and performance of the packaging materials used for the injection shall not be inferior to that of the reference preparation
6. According to ICH Q3D, the control strategy for element impurities is developed through scientific and risk-based assessment, including elemental impurities leached from the 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