USP Advocates for the Use of Pharmacopeial Standards and Regulatory Compliance at CPhI China 2015

PRESS RELEASE

Shanghai, June 26, 2015 — The U.S. Pharmacopeial Convention (USP), a global health organization that aims to improve lives through public standards for foods and medicines, hosted a seminar on pharmacopeial and regulatory compliance at CPhI China 2015 to help industry leaders and experts deepen their understanding of the latest quality standards and regulatory updates.

Former officials from the U.S. Food and Drug Administration (FDA), experts from USP and the Chinese Pharmacopoeia Commission (ChP) as well as senior executives from pharmaceutical companies were invited to deliver keynote speeches. Over 120 industry leaders and executives from domestic pharmaceutical companies participated in the seminar.

“In recent years, we’ve seen an increasing number of Chinese pharmaceutical companies that are expanding internationally. It is necessary for these companies to be compliant to the latest pharmacopeial quality standards and regulations in order to run businesses in a stringent regulatory market.

“To address growing demands, USP is committed to helping these companies meet pharmacopeial standards, provide training and certification services to help them comply and also guide them to contribute towards shaping global standards,” said Dr. Feng Bingbing, chairman of the seminar and USP-China General Manager.

The USP seminar focused on key industry concerns related to global and local pharmacopeial standards and regulations. Industry’s concerns are closely aligned with recent efforts made by the Chinese government to step up the regulation of local quality and safety standards, strengthen compliance monitoring and enforce strict penalties and related accountability for food and medicines safety. Other key event highlights include:

• USP’s requirements for elemental impurities (which will replace USP’s existing standard for heavy metals) effective in 2018;
• US FDA’s new initiative, the Quality Metrics Program, and the use of big data to improve regulatory effectiveness;
• US Generics Market Overview: Opportunities and challenges for Chinese companies;
• ChP 2015 Overview, which is to be effective by December 1, 2015.

"China is a major exporter of raw materials for pharmaceuticals, and increasingly for drug products, throughout the world. USP places great importance on the Chinese market, and we are committed to supporting the growth of local industry. To this end, we have built R&D and training facilities with an area of 10,000 square meters in the Shanghai Pilot Free Trade Zone to better serve their needs. We will strengthen our collaboration with the Chinese Pharmacopoeia Commission and other partners to share knowledge on pharmacopeial standards, promote industry developments and improve public health,” said Dr. Feng Bingbing.