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Regulatory Changes in China to Impact Many Areas

by Hongyang Li, Novartis, PDA Regulatory and Quality Advisory Board (RAQAB) member | Feb 26, 2018

Recently, I had the pleasure of providing an update on Chinese regulatory trends to PDA’s Regulatory Affairs and Quality Advisory Board (RAQAB). In general, while there are many new regulations coming from the China FDA, it appears Chinese regulators are striving to make sure their regulations are more aligned with international practices.

This reflects statements made by CFDA Director Bi Jingquan on Oct. 10 following release of the document, Opinions on Deeping the Review and Approval System Reform and Encouraging the Drug and Medical Device Innovation. In his remarks, he pointed to the need to expand China’s development of innovative drug products as well as increase importation of new drugs from abroad for serious diseases, noting that, from 2001 to 2016, the U.S. FDA approved 433 new drugs, yet only 133 of them have been marketed in China. At the same time, safety and quality of drug products should be ensured.

Below are the highlights I shared with RAQAB:

  • All post-approval changes (PAC) must be submitted online as of Dec. 1, 2017; these will be reviewed centrally by CFDA’s Center of Drug Evaluation (CDE) as provincial CFDA offices will no longer accept nor review PAC submissions
  • The Market Authorization Holder program will be implemented in China in the future (right now, only ten provinces/cities are allowed to participate the MAH pilot program); this change could have a dramatic impact on the Chinese pharmaceutical industry, for example, the term “imported drug” will now refer to drugs manufactured outside China but marketed in China, which may mean reduced testing at customs (some provinces have already dropped the testing fee for imported drugs in China)
  • APIs will be reviewed in conjunction with NDA and ANDA applications, and there will no longer be a separate CDE review of API applications; API manufacturers are encouraged to file Drug Master Files with the CFDA, and there will be no “pharmaceutical production license” issued to API manufacturers in China
  • The “GMP Certificate” issued by CFDA will cease; the intent is that preapproval inspections (PAI) will cover general GMP inspections as well
  • The five-year GMP recertification for onsite inspections will be converted to routine onsite GMP inspections based on a risk model being developed by CFDA
  • A revision to the Drug Administration Law is expected to be passed in the next Chinese Congress sometime in Q1 2018 so as to enable the above changes
  • A new piece of Chinese regulation pertaining to “Drug Data Governance” has been published for comment—this is the third version published for commenting (PDA commented on the first version of the regulation), and the contents are now more aligned with current international guidelines regarding data integrity; this regulation is intended to govern data integrity and reliability in the whole lifecycle of pharmaceutical products in China, covering GxP, not only GMP

Anyone interested in learning more about Chinese regulations is encouraged to contact Denyse Baker.