SHANGHAI - The Shanghai Institute for Food and Drug Safety and the Parenteral Drug Association signed a memorandum of understanding earlier this month to accelerate and improve the quality of pharmaceutical manufacturing in China through enhanced international cooperation.

"The MOU reflects our determination to meet advanced international standards swiftly," SIFDS Director Gao Huijun told PharmAsia News. "As the pharmaceutical industry develops rapidly in China, there are higher industrial standard requirements for the raw material supply chain, pharmaceutical quality assurance and quality control, as well as a better understanding of relative regulations."

Gao added that China currently has no organization like PDA specifically involved in pharmaceutical quality assurance and quality control guidelines to provide such help to pharmaceutical manufacturers.

"There are only a few dozen PDA members in China, which are mostly multinational companies, and local pharmaceutical firms are not very aware of the PDA," Gao said. "This MOU also aims to promote and recruit more members in China through setting up a PDA branch."

PDA, based in Bethesda, Md., and SIFDS, with the support of Shanghai Municipal FDA, will establish the SIFDS/PDA Shanghai Joint Development Center.

"SHJDC will help us to introduce advanced management concepts from developed countries," Gao said. "We will absorb advanced supervision technology systematically and dynamically to improve our administration levels, as well as learn new trends in pharmaceutical industrial surveillance from such countries."

The joint center will help publish PDA publications in China and assist PDA in organizing conferences and training sessions.

PDA President Robert Myers told PharmAsia News that the first meeting, to be held in Shanghai early next year, will address supply chain integrity, particularly aseptic processing science.

"What this is good for is for people who are actually making a product, and on the flip side, the people who are inspecting, like the inspectorate in China, would learn what to look for when they are going to a sterile manufacturing operation to make sure that the product is sterile," Myers said.

"Our mission is to bring science to the people that need it. We were requested by Shanghai FDA to set up meetings and training, and that is right in line with our mission. … We do technical reports on science with [U.S.] FDA and EMEA, so doing it in China is a very natural fit," Myers added.

"This is a platform that we can air our opinions, communicate and exchange information with an international organization," SIFDS' Gao said.

To improve expertise in China, SIFDS is actively seeking international cooperation, according to Gao. SIFDS also hopes to develop a personnel training exchange with the International Society for Pharmaceutical Engineering and is working with the China Law Center at Yale Law School for training on pharmaceutical regulations like recall systems.

Gao noted that cooperating with international organizations makes Shanghai FDA and SIFDS more transparent in their operations and boosts the dialogue between regulators and industry. SIFDS also has an agreement in place with U.S.-based law firm Sidley Austin to review drug laws worldwide and host a series of global exchanges (Also see "Shanghai FDA Signs Agreement With U.S. Law Firm To Foster International Cooperation on Drug Regulation" - Scrip, 7 August, 2008.).

-Ying Huang (pharmasia@elsevier.com) and Daniel Poppy (d.poppy@elsevier.com)

[Editor's note: PharmAsia News will host a webinar Oct. 15 for pharmaceutical and medical device firms entitled "U.S. FDA Inspections in China." For more information, please click here.]

U.S.-China Groups To Work Together On Pharma Quality Control

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