April 10, 2017

China has often faced criticism for lax regulation of drug and medical device manufacturing. In addition, long-term accusations of bribery for inspection favoritism is still a real concern.  Do recent life sciences regulatory compliance concerns addressed by new regulation mean that’s changing?

Regulation Pushes for Manufacturing Reform

On February 9, the State Council of China published “Opinions of Further Reform and Improvement of Drug Manufacturing and Distribution Policies.” The new Opinion addresses life sciences regulatory compliance concerns and mandates that the China Food and Drug Administration (CFDA) implement nearly 20 action items spanning product life cycles.

As stated by international business law firm Sidley Austin, some life sciences regulatory compliance requirements are not entirely new. But, the updated Opinion indicates a hard push from Chinese government to implement these compliance requirements “expeditiously, despite suspicions and questioning from the industry.”

The Opinion does not say “medical device manufacturing” in its title. However, many of its standards will apply based on the Opinon’s phraseology, according to Sidley Austin and other experts. The document lays out 17 specific regulatory demands. In terms of quality and regulatory compliance concerns, two of critical relevance stand out:

  • Manufacturers must improve their drug approval procedures. The document was relatively vague in terms of expected results.  However, ensuring data authenticity and speeding the approval process are likely top concerns.
  • The CFDA must conduct stronger good clinical practice (GCP) and good manufacturing practice (GMP) inspections. The focus is on data integrity and data management inspections and monitoring of GMP compliance.

Life Sciences Regulatory Compliance Concerns Target GMP Violations

With China being one of the largest producers of drugs and APIs sold in the U.S., poor quality practices can have wide-reaching effects.  The new regulation comes on the heels of heightened U.S. Food and Drug Administration (FDA) inspections in China. The inspections have resulted in a significant increase in warning letters. Probably not much of a coincidence. In most cases, GMP failures are at the top of the FDA’s list.

FDA Regulatory Compliance Concerns: Data Integrity

For example, the agency has questions for a facility run by Chonquing Pharma Research Institute, an API maker. Citing several GMP concerns, a recent FDA warning letter to Chongquing questioned the accuracy of data used by the drug manufacturer to validate product quality, safety, and efficacy.

As a result, the FDA requested a detailed corrective action plan over these regulatory compliance concerns. The plan requests details on how the API manufacturer intends to ensure the reliability and completeness of all the data it generates.  This includes analytical data, manufacturing records, and all data submitted to the FDA. In addition, the FDA wants a comprehensive root cause analysis citing the reasons for the data integrity lapses. Finally, the FDA wants evidence that the scope and depth of the current action plan aligns with the findings of the investigation and risk assessment.

FDA Regulatory Compliance Concerns: Supplier Management

Separately, the FDA issued a January 31 letter to Ausmetics Daily Chemicals (Guangzhou). The FDA alleges Ausmetics failed to ensure that the components sources from various suppliers include its own active ingredients.  As drug and medical device manufacturing continues to globalize, the FDA wants clear evidence Ausmetics maintain firm oversight of its supplier management.

FDA Regulatory Compliance Concerns: Document Access

Another interesting issue was raised in a January 26 letter to manufacturer Zhejiang Bangli Medical Products Co. In that case, the FDA hit the medical device manufacturer for delaying, limiting or in some cases outright refusal to let an FDA inspector do their job on site.

It’s impossible to know whether Zhejiang’s actions were the result of disorganization, obstruction, or several other more benign scenarios. Nevertheless, the warning letter is a reminder that a quick way to run afoul of the FDA is to be slow retrieving documents it requested.


FDA warning letters pertaining to overall life sciences regulatory compliance concerns sent to Chongquing, Ausmetics and Zhejiang should also serve as notice for any medial device or pharmaceutical manufacturer. The production and distribution of drugs, APIs and medical devices internationally requires a global quality management system like AssurX. When the FDA exposes a problem, drug and medical device manufacturers must use the opportunity to demonstrate good faith and take the necessary steps to meet cGxPs and maintain regulatory compliance. That’s a glaring green light to engage an experienced life science manufacturer to identify eQMS solutions, best practices, and start a remediation plan.

Time will tell how these regulatory compliance concerns are further clarified and enforced by the CFDA. Nevertheless, the Opinion strongly suggest that oversight of drug and medical device manufacturers operating in or depending on supplies from China should expect increased regulatory compliance scrutiny in one form or another.

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