China Drug GMP Update

Despite the ongoing political frictions between the US and China, many Western pharmaceutical companies still rely heavily on Chinese drug companies for the production of APIs, excipients, and finished drug products. To source drug components and drugs from China, meeting Western GMP standards is critical. While Chinese GMP has come a long way, there are still differences between Chinese GMP and US GMP standards.

China GMP regulations were promulgated more than 20 years after the US. In 1998, China initiated GMP regulations, and in 2010, the government upgraded their GMP regulations for the 4th time resulting in a new GMP version which went into effect in March 2011. These new GMP regulations had 14 chapters, over 300 articles, and a number of appendices. One of the main purposes of these regulations was to change Chinese standards from quality by test to quality by design. In 2017, China became a member of the ICH which now allowed China to harmonize its drug regulations with global standards further. Despite ICH entrance, whether China’s GMP standards can meet US/EU GMP standards is still a big question.

According to a report issued in Frontiers in Public Health 2023 titled – Characteristics, Risk Management, and GMP Standards of Pharmaceutical Companies in China – four main observations were made about China’s GMP. First, this report states that in general, foreign, and privately owned drug companies’ operations in China have better GMP standards than local public Chinese drug companies. Second, a Chinese drug company usually does not have as good a GMP system if its financing is backed by bank loans versus private investment. Third, drug companies in China with fewer fixed assets do not do as well with respect to GMP as drug companies that have more fixed assets. Simply, bigger Chinese drug companies usually do better than smaller less well-funded drug companies with their GMP. Fourth, better GMP results can usually occur when a drug company is able to retain its key quality employees and has less turnover. Of course, the Chinese pharmaceutical company’s success is directly correlated with the quality of its staff especially those who have gained experience with Western Good Manufacturing Practice (GMP) standards.

While some Chinese drug companies now meet Western GMP standards, many others still have a way to go. Besides providing drug components and finished products to Western drug companies, it is clear that Chinese companies that meet Global GMP standards will also have more success selling their own drug components and products internationally. Accordingly, some Western drug companies are now in-licensing Chinese drugs.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.