BEIJING - In the wake of a series of vaccine scandals across China during the past year, triggering sometimes fatal adverse events, China's State FDA is strengthening rules governing the manufacturing, distribution and inspection of vaccines nationwide.

The new regulations, slated to take effect later this year, are apparently aimed at elevating vaccine safety standards and at restoring confidence following a massive public boycott of many domestically made products in reaction to the scandals.

SFDA also aims to upgrade the thoroughness and effectiveness of reglatory inspections of vaccine facilities China-wide, Yang Chen, a partner at the Beijing offices of the international firm Sidley Austin, said in an interview.

In a formal document on heightened vaccine safety and quality standards recently issued by SFDA, China's drug regulator will "require manufacturers to gradually upgrade quality standards for marketed vaccines," Yang explained in a commentary jointly written with a team of Sidley lawyers.

SFDA Setting Up New Panel Of Experts On Vaccines

"An expert panel will be formed by SFDA to evaluate the worth of vaccines based on industry policies, demand/supply, quality standards and quality assurance system of the manufacturers in order to guide the R&D, manufacturing and regulatory approvals," the Sidley lawyers stated.

The new rules will be applicable to all vaccine production facilties in mainland China, including, for instance, a massive joint venture that is being constructed in central Hunan Province by the Canadian biotech outfit Microbix Biosystems (Also see "Massive Vaccine Joint Venture With Canada's Microbix Will Help China Prepare Defense Arsenal Against Viral Threats Of The Future" - Scrip, 17 December, 2009.).

Producers of vaccines must closely adhere to good manufacturing practice standards and related regulations, and must tag products with electronic identifiers tied to SFDA's expanding electronic database, explained Yang Chen ('Also see "China’s 2009 Regulatory Changes Will Affect Makers of Drugs, APIs and Devices" - Scrip, 5 January, 2009.).

More Stringent Inspection Standards

Meanwhile, drug regulators in the Chinese capital are calling on colleagues at provincial-level FDA organizations "to improve the quality of on-site inspection during the regulatory approval process and strengthen routine supervision of high risk manufacturers," she stated in the commentary.

"If any serious safety risk is identified during the routine inspection," the team of Sidley lawyers explained, "the responsible provincial FDA should immediately order a cease of production, demand recall of released vaccines, and suspend batch release of any vaccine manufactured by the specific manufacturer until it rectifies the safety issue."

The steeper inspection standards are expected to lead to a higher degree of scrutiny and overall safety levels across China's provinces, Yang said during the interview.

Higher standards could also help weed out weaker players, benefiting multinational vaccine manufacturers like GlaxoSmithKline, which has seen an increase in its marketshare in China due to the vaccine scandals (Also see "Hit Collaterally By Popular Backlash Following Vaccine Scandals, China's Sinovac Could Exploit High Quality Standards To Emerge As Winner" - Scrip, 21 July, 2010.).

Mandatory Phase IV Studies

Meanwhile, Phase IV studies will be required for all newly approved vaccines, according to the SFDA regulations.

As part of these stricter regulations on the production, marketing and monitoring of vaccines, Yang added in the commentary, "SFDA will require detailed records about the source, history, and biological characteristics of the microbial or pathogenic strains and cell lines used for vaccine development in the regulatory dossiers."

Counterfeit And Substandard Vaccines

There have been scattered reports from around the country of extreme adverse reactions to vaccines and injuries stemming from counterfeit products; in one case, the state-run Xinhua News Agency revealed that an Intermediate People's Court in the remote region of Guangxi sentenced eight defendants to short jail terms for selling a fake rabies vaccine that led to the death of a five-year-old boy ('Also see "China's Leading Vaccine Developer Sees Sales Slashed Due To Popular Backlash Against Series Of Scandals" - Scrip, 11 January, 2011.).

In a separate incident, the leadership of the Nanjing-headquartered Simcere Pharmaceutical Group, which is listed on the New York Stock Exchange, disclosed that its newly acquired subsidiary Jiangsu Yanshen Biological Technology had been found liable for producing a substandard rabies vaccine and fined RMB 30 million.

Sinovac Biotech, one of China's leading vaccine developers, has reported a slide in earnings over the past year due to a widespread public fear of 'Made in China' vaccines. The company believes it will benefit from a push by SFDA to increase standards, which would help differentiate quality vaccines from inferior products.

- Kevin Holden (k.platt@elsevier.com)

Chinese Drug Regulators Issue New Rules To Increase Safety Standards Of Vaccines

More from Archive

More from Scrip