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China’s SFDA Moving Toward Expanding Supply Chain Auditing and Filing Requirements

China’s State Food and Drug Administration (SFDA) has released a draft of a new regulation that would significantly expand the supply chain auditing and filing requirements for manufacturers of active pharmaceutical ingredients (APIs) and packaging as well as drug products.

Among other provisions, the regulation would require that manufacturers of APIs and “pharmaceutical auxiliary materials” conduct audits of the “qualification and quality assurance system” of the suppliers of their starting materials and intermediate products, and submit the audit reports with their filing information.

The proposed regulation represents an aggressive step by the Chinese government toward building a system that can address the problems of contaminated and sub-quality products that have plagued both the domestic and global marketplace.

SFDA notes that the document reflects an effort to borrow from and build on the drug master file (DMF) system in the US and Europe and to address the lack of traceability and transparency that has hampered SFDA from tackling the problems in the Chinese supply chain.

The Chinese regulatory agency is also taking a westernized approach in the way in which it is asking for comments.

Comments from “relevant divisions, bureaus and directly reporting units” of the SFDA and the food and drug administration agencies of “all provinces, autonomous regions and municipalities” are requested to be submitted by October 15.  Significantly, SFDA is also reaching out for public input.  Other “units or individuals” will have until October 30 to supply comments.

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Entitled “Administration of APIs and Pharmaceutical Auxiliary Materials,” the requirements in the draft would apply to all APIs, traditional Chinese medicine extracts and pharmaceutical excipients as well as “raw and auxiliary materials” used for packaging and containers that come into direct contact with drug products.

The new regulation is meant to “strengthen the administration” of these materials and proposes new requirements for submission and amendment of drug filing information.

It is intended to clarify the “relationship between and the respective responsibilities of the drug product manufacturers and the API and pharmaceutical auxiliary materials manufacturers…and more clearly define the drug product manufacturers as the primary responsible persons for the product quality.”

Umbrella Regulation to be Followed by More Specific Guidances

The document is divided into six chapters: ● general provisions ● basic requirements ● submission and change of filing information ● application of filing information ● administration of filing information, and ● supplementary provisions.  Also included is an appendix titled “explanations of the draft.”

Once approved, the umbrella regulation will be followed by a series of guidances to flesh out the “specific contents and requirements” as experience is gained.

The general provisions chapter notes that SFDA plans to establish a “uniform…filing information platform” for drug applications that will be used for APIs and auxiliary materials by the central agency as well as those in all provinces, autonomous regions and municipalities.

The second chapter sets forth requirements and responsibilities for drug product manufacturers and their suppliers.  It requires suppliers to allow auditing by the drug product manufacturers they supply as well as mandating quality agreements between those parties, specifying the respective responsibilities of each.

The “submission and change of filing information” chapter focuses on auditing and change control requirements.  It calls for an API or auxiliary materials manufacturer making a process change to assess its impact on product quality, update its drug filing information, and notify the drug product manufacturers it supplies. In turn, the drug product manufacturer must audit the firm regarding those changes.

The fourth chapter lays out drug filing administrative procedures and requires drug product manufacturers to audit their suppliers, while the fifth chapter requires that the drug product firm “immediately stop using such API and auxiliary materials” from the supplier if any discrepancies are found between the audit findings and filed information.  The latter chapter also stresses that SFDA will refuse to accept new drug filings for a period of five years if it finds any ”falsified information” in a drug filing.

The last chapter on “supplementary provisions” leaves open-ended when the regulation will come into force.

In the appendix, SFDA provides explanations of and background on the six chapters and further elucidates the principles and implementation of the new regulations.

The agency notes that the DMF system used in the US and Europe “has been adopted for most APIs and pharmaceutical auxiliary materials in China.”  Under the new reg, the filings will include public information, non-public information and the filing number.

The appendix highlights the significance of what the new regulation is trying to accomplish.

SFDA emphasizes that “at present, China does not have the information and relevant information platform linking the APIs and pharmaceutical auxiliary materials” to the drug products in which they are used.  The new system is designed to “help trace the sources and enhance the efficiency of supervision and administration.”

SFDA also clarifies that the proposed regulation applies only to APIs and pharmaceutical auxiliary materials that will be used in drug products that are registered in China.

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