Excipient Control Strategies in China - Pharmaceutical Technology

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Excipient Control Strategies in China
As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.


CPhI Focus: Pharmaceutical Ingredients


IPEC–CCPIE excipient-control strategies conference

More than 150 people participated in an International Excipient Control Strategies Conference in Beijing on March 13–14, 2007. The conference was organized by the China Center for Pharmaceutical International Exchange (CCPIE), IPEC Americas, IPEC Europe, and the Japanese Pharmaceutical Excipient Council (JPEC), with help from the Research and Development-Based Pharmaceutical Association Committee (RDPAC) in China. The meeting attracted at least 30 SFDA division directors and other agency personnel, plus many Chinese and international excipient and finished-drug manufacturers.


Goals of the International Excipient Control Strategies Conference
The conference was designed to provide the pharmaceutical and excipient industry, SFDA, and several major pharmacopeias an opportunity to interact on topics related to the control of excipients used in pharmaceutical products marketed in China and the rest of the world (see sidebar, "Goals of the International Excipient Control Strategies Conference").

Speakers at the conference included Zhang Wei, director of SFDA's Department of Drug Registration; Wang Ping, deputy general secretary of the Chinese Pharmacopeia; Dr. Agnes Artiges, director of the European Pharmacopoeia; Dr. Kiyomi Ueno, director of the Japanese Pharmacopeia's standards division; Dr. Roger Williams, chief executive officer of the US Pharmacopeia (USP); and Dr. Catherine Sheehan, USP's director of excipients. Several industry speakers from IPEC member companies described how pharmaceutical excipients are evaluated for safety and controlled for quality throughout Europe, Japan, and the US. Song Ming Xian, director of the regulatory division of the Sichuan Provincial Food and Drug Division, summarized current SFDA excipient GMP regulations and described the need for a Chinese industry association dedicated to improving excipient quality.

Zhang Wei, director general of SFDA's registration department, gave the opening speech, which provided interesting information about what direction SFDA may take when it revises the draft excipient regulations. He provided his vision of how SFDA might regulate excipients in the future.

In his speech, Wei addressed many of the issues that the IPEC Coalition had raised regarding SFDA's draft regulation, and he indicated that more flexibility is warranted. Wei recommended that the licensing requirements for the most common compendial excipients could potentially be eliminated and that a DMF-type system be established for premixed and coprocessed excipients. He stressed, however, that a detailed licensing system would need to be set up to control excipients intended for injections because of the high level of risks associated with these materials.

SFDA's concepts regarding this regulation have changed significantly since the agency proposed its original draft. At that time, it appeared that the agency would publish a regulation that would create great difficulties for industry without benefiting consumers. The ongoing dialogue between the IPEC Coalition and SFDA seems to have influenced the debate over the regulations in a positive way.

All the speakers described how excipients are controlled from various perspectives in each major market region. The excipient conference provided a valuable overview of global excipient regulations.

After the conference, Wei reported that the expected redraft of SFDA's excipient regulations in China would be postponed until 2008 and that some changes might be based on comments made to the agency.

IPEC discussed the formation of an industry-based excipient working group in China, which is currently being explored. IPEC proposes to organize an excipients organization in China that would be similar to other IPEC groups. Each group originally formed after a major excipients conference at which it became obvious that such a group would benefit the industry, pharmacopeias, regulatory agencies, and consumers. IPEC hopes to form an excipients working group in China in late 2007 and has continued working with SFDA since the March 2007 conference on excipient controls.

SFDA visits US manufacturing facilities

IPEC Americas worked with the US Department of Commerce to enable SFDA to visit two excipient-manufacturing facilities and one API-manufacturing facility. SDFA representatives conducted visits during their trip to the Annual JCCT meeting in Washington, DC, on April 9–12, 2007. SFDA wanted to tour excipient and API facilities to see how US manufacturing facilities for excipients and APIs meet GMPs. The agency also wanted to understand how manufacturing processes for these materials are controlled in the US.


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