USP Looks To Maximize Opportunity As China Builds Drug Standards

A relationship initiated in the wake of a fatal heparin scandal between USP and the China Pharmacopeia Commission is going strong, presenting opportunities for companies like Sanofi and China’s Tasly as the Middle Kingdom gets set to expand drug standards.

BEIJING – The U.S. Pharmacopeial Convention (USP) and the Chinese Pharmacopeia Commission (ChP) are strengthening bonds through personnel exchanges, translating standards and joint verification as China invests to build up capacity for drug standardization.

The relationship has been “terrific,” USP CEO Roger Williams told PharmAsia News Nov. 11 in Beijing, where he was invited by ChP to meet officials at China FDA. Williams later went on to Guangzhou where he attended the second annual China Pharmacopeia Science and Technology Conference.

“The working relationship is very positive because we are doing the same thing; we have chemical drugs and biologics. The traditional Chinese medicine (TCM) is a different thing … but I think that we have made progress there.”

The bilateral relationship started as USP collaborated with Chinese experts and regulatory officials to enhance food and drug safety after Chinese-sourced heparin caused adverse reactions and deaths across the United States.

In 2008, USP and ChP signed a memorandum of understanding, along with China's National Institute for the Control of Pharmaceutical and Biological Products (NIFDC) and Chinese provincial authorities (Also see "U.S. Pharmacopeia Ramps Up Drug Quality, Safety Cooperation Across Asia With Four New Agreements With China, ASEAN States" - Scrip, 26 Jun, 2009.).

The memorandum was expanded in 2010, when USP signed an agreement with China's Center for Disease Control and Prevention (CDC) (Also see "After Signing Pact With Chinese Regulators, U.S. Pharmacopeia Seeks To Develop New Tests To Help Prevent Deadly Episodes of Adulteration" - Scrip, 17 Sep, 2010.).

Two working groups have been established, one to address standardization, and the other to support personnel exchange. Each year, USP executives come to China and meet with China FDA and ChP officials, and the two organizations have annual meetings, with the latest one held in Baltimore, Maryland in September.

“The meeting with China goes beyond bilateral,” said Edward Zhao, vice president for business development and allied compendia programs at USP. In September, ChP and USP jointly hosted a global summit on pharmacopeia, in addition to the bilateral conference.

According to Williams, who was appointed by ChP as its first overseas “honorary councilor,” the vision for China is to develop a globally respectable pharmacopeia. As a partner, USP wants to be on board during the journey.

“In the next cycle, we’d like to set up expert committees here in China,” Williams said.

Jiasheng Tu, a professor at Chinese Pharmaceutical University, currently heads a USP committee on excipients, and Dean Guo, director of the Shanghai Research Center for TCM Modernization, leads an excipients expert panel. USP intends to set up an expert panel on chemical drugs in China, according to Williams, saying it “will bring the USP standard-setting activities to the very sophisticated scientists in the Chinese science community.”

USP is also set to unveil an expanded laboratory facility in Zhangjiang Hi-Tech Park in Shanghai. The new facility will be roughly 100,000 square meters, a tenfold expansion, and will be equipped with state-of-the-art devices. The new facility will extend from chemical standards research to biology, microbiology, and food ingredients.

Looking Forward At The Provinces

The newly expanded laboratory will allow USP to work better with China’s provincial-level testing facilities and strengthen both USP and ChP monographs, Williams said.

“We’ve covered the science part, and now we can do research and development together,” he said, adding that China has invested heavily in provincial-level testing laboratories.

In a bid to beef up capabilities to secure food and drug safety after a series of scandals, China invested RMB 1.09 billion ($17.8 million) to build a new facility for NIFDC. Similar investments are pouring into China’s provincial-level testing labs.

“Many of these are very sophisticated facilities inside the food and drug control system. If we can work better with them in their next five-year cycle, we can strengthen both USP and ChP monographs, and that will be a true win-win partnership,” Williams said. “By 2020, we will have some major achievements.”

To bolster the relationship, USP hosts a minimum of four visiting scholars from ChP and provincial testing institutes each year, and they stay between three to six months. Currently, a deputy director from ChP and one from NIFDC are stationed at USP and a deputy director from the Beijing Center for Disease Control will join USP soon, Zhao said.

Companies Stepping In

China’s effort to strengthen pharmacopeia monographs and standard setting has attracted attention from companies eager to partner.

During the September meeting in the U.S., Sanofi sent a team to meet officials from ChP, including General Secretary Wei Zhang, Deputy General Secretary Ping Wang and Chief Scientist Zhongzhi Qian.

The Sanofi team was led by Global Pharmacopeia Chair Stephan Schmidt and Pharmacopeia Affairs Head Brigitte Chapart. Sanofi’s delegation included Ning Li, the company’s vice president for regional regulation affairs in Asia and Ruiqi Wang, point of contact for ChP.

According to a ChP press release, Sanofi expressed its intention to work with the organization to strengthen international collaboration, academic exchanges and overseas conferences.

Zhang said ChP welcomes and encourages both multinational and domestic pharmaceutical companies in its efforts to strengthen the China Pharmacopeia. To meet the demand for further internationalization, the organization plans to establish an English language website, Zhang said.

ChP has also started comparing standardization with other countries, which is a step toward further harmonization, Zhang said.

Harmonization is an area where Big Pharma will take a particular interest. In 2011, a change in vaccine standards in the China Pharmacopeia caught many multinationals by surprise, and meant that certain vaccines could no longer be imported into China. The change hit GlaxoSmithKline PLC particularly hard, and continues to be a drag on the company’s China business, with GSK saying about 15% of its sales decline in the third quarter was due to the new vaccine standards (Also see "Signs Of R&D Progress For GSK, Though China Overhang Remains" - Scrip, 24 Oct, 2013.).

In addition to MNCs, local companies are also taking an increasing interest in the China Pharmacopeia. Chinese domestic firm Tasly Pharmaceutical Co. Ltd., one of the major traditional Chinese medicine manufacturers, approached ChP to work towards modernizing monographs for TCMs.

During ChP’s visit to the U.S., Tasly Chairman Xijun Yan and Tasly Inc. CEO Henry He Sun gave the officials a tour of Tasly’s Rockville, Maryland facility and discussed ways to promote TCM products to the world via standardization.