Comments Sought for Administration of Overseas Drug Manufacturers

China’s State Food and Drug Administration (SFDA) released the “Administrative Measures for the Inspection of Overseas Drug Manufacturers (Draft for Comments) (hereinafter referred to as ‘Draft’)” on August 20, and is now seeking public comments. All the comments should be submitted by October 8, 2012.

According to the Draft, for overseas drug manufacturers who need to postpone the on-site inspection after receiving the on-site inspection notice due to special reasons, its agency shall send a written application explaining the reasons to the certification management center of the SFDA. Enterprises that reject the on-site inspection without a valid reason – or fail to cooperate with the on-site inspection – shall be regarded to have failed the on-site inspection.

Assessment standard

The certification management center of the SFDA shall, based on the risk management principle, comprehensively assesses the inspection within one month after receiving the rectification reports from agencies. The conclusion of the inspection is divided into:

• Compliant;
• Non-compliant; and
• Compliant after rectification

The assessment standards are as follows:

Where the production of drugs and quality control are consistent with the application materials and the drug production can be carried out according to GMP standards, the enterprise shall be concluded as “complaint.”

Where several major defects have been detected during on-site inspection and the drug production can still be carried out according to GMP standards based on the submitted rectification report, the enterprises shall be concluded as “complaint after rectification.”

Where fraudulent acts have been discovered or the key factors that affect the production quality are inconsistent with the application materials, and the inspected institutions are unable to carry out production in accordance with GMP standards due to serious defects or several major defects, the enterprises shall be concluded as “non-compliant.”

Punishment for non-compliance

The SFDA will issue a “warning letter” to the agency of the enterprise listed as “non-compliant” after inspection and suspend its import of the drug, or suspend its drug registration examination and approval process until it meets the inspection requirements. The SFDA may order the enterprise to recall the drug or take other appropriate measures based on the severity of the circumstances. Under special circumstances where an overseas drug manufacturer has serious defects that will largely jeopardize public safety, the SFDA may make the above decisions immediately.

Documents for inspection

According to the Draft, the documents provided to the certification management center of the SFDA for inspection include the following:

• On-site documents – Including information from the enterprise on its production quality management system, personnel, factory buildings, equipment, documents, quality control, distribution, product complaints, product defects, product recalls, and self-checks.
• Basic information of imported drugs for the last three years – Including information on imported quantity, port inspection, adverse reactions, product complaints, and product recall.
• Basic information on production and sales of the imported drugs in other countries for the last three years – Including information on whether the products have been suspended from importing due to non-compliance with GMP standard or have been recalled due to quality defects.

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