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Practice makes perfect for drug makers eyeing US (2006-04-27)

Chinese pharmaceutical companies that want access to the international market are learning how to raise their management standards from the US Food and Drug Administration (FDA), one of the world's strictest regulators.

Co-sponsored by the FDA and the State Food and Drug Administration (SFDA) of China, a three-day training programme on the FDA current good manufacturing practice (GMP) for finished pharmaceuticals concluded yesterday at Peking University.

GMP is the necessary practice that a pharmaceutical company must exercise to produce medicine.

More than 4,000 pharmaceutical companies have achieved China's GMP level, said Bian Zhenjia, director-general of the Department of Drug Safety and Inspection under the SFDA.

However, he said that China's GMP was adopted in 1998 and lags far behind that of the United States.

"We've already begun to revise it," he said, "not only to ensure the quality and effectiveness of our medicines, but also with the hope of sharpening the international competitiveness of domestic pharmaceutical companies to eventually win international recognition."

Though China is the largest raw medicine material exporter in the world, not a single tablet of finished Chinese pharmaceuticals has entered the US market, Bian said.

"The FDA standard definitely is one of the strictest in the world," said Diao Li, director of research of the Centre for Pharmaceutical Information and Engineering Research.

"If we can meet that standard, our medicine can go anywhere in the world."

Bai Hua, president of Zhejiang Hisun Pharma Co Ltd, said: "I am here to learn from the management of the US, new policies as well as the risk of the US medicine market."

Joseph Famulare, director of the Office of Compliance in the Centre for Drug Evaluation and Research under the FDA, said they were discussing with Peking University about co-operation on a future postgraduate programme to train more pharmaceutical professionals who know GMP.

"We hope to put in the academic field a permanent place to have this interaction with various regulators here so that the programme will be imbedded (in China) and will be able to produce students who have understanding of GMP," he said.

(China Daily)



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