39 Pharmaceutical Products to be Checked on Site, Foreign Pharmaceutical Enterprises Having Defects

Center for Food and Drug Inspection of CFDA issued the Announcement on On-site Checking Plan for Drug Clinical Trial Data No. 11 on April 28.

With a plan to carry out on-site checking on the 39 drugs that have been conducted self-inspection and checking of clinical trial data, including Insulin Degludec Injection (acceptance No.: JXSS1500010, JXSS1500011), etc. (see the attachment for the details), the announcement is hereby publicized for 10 working days, from April 28, 2017 to May 12, 2017.

Pharmaceutical products to receive the on-site checking this time are all from foreign pharmaceutical enterprises including Eli Lilly, AstraZeneca and Novo Nordisk, etc.

Attached: Catalog of varieties to be checked the drug clinical trial data on site

The U.S. Food & Drug Administration (hereinafter referred to as "FDA’) posted a warning letter to China Xiaoshan Plant of Teva Pharmaceutical, an Israeli generic drug giant, on April 10, showing the deficiencies of the plant including failure to monitor the critical process parameters, recurrence of product quality failures, ineffective root cause analysis and CAPA, failure to establish a sampling plan based on scientifically-sound sampling practices, unreasonable process validation sampling, failure to describe how the continued process verification program assures that quality attributes continue to be met batch-to-batch, etc. This was the second warning letter received by Teva in the past 6 months. Before this, FDA has issued a warning letter to the aseptic production factory of Teva in Hungary on October 13, 2016.

The Medicines and Healthcare Products Regulatory Agency (MHRA) announced in 2015 that the Tianjin Factory of GSK was found to not meet EU GMP certification requirements in an unannounced inspection, and the current GMP certificate and previous GMP certificate of the factory were both taken back.

Desires of foreign pharmaceutical enterprises to accelerate localization strategy have become increasingly strong in recent years, and the localization modes have gradually become diversified, including setting up factories in China, upgrading the R&D centers in China, merging Chinese enterprises, and establishing joint ventures with Chinese enterprises, etc.

Some data show that there were 631 patent drugs becoming off-patent in the world in 2012-2016; 18 among the 20 global best-selling prescription drugs are to be off-patent, and the global annual sales of those 18 prescription drugs are USD 142 billion.

As such, foreign pharmaceutical enterprises are seeking changes in their strategies in China to adapt to the new circumstance. Strengthen their concentration and comparative advantage by stripping non-core business; seek new market opportunities by turning their eyes to cultivating the grassroots market; besides joint ventures, foreign pharmaceutical enterprises have begun to strengthen cooperation with local enterprises, and they strive to achieve win-win cooperation through the resultant force of the marketing channel and OEM. Many foreign pharmaceutical enterprises had weak global performance in 2016, but had rapid growth in the Chinese market, therefore, they are competing to build factories in China, shifting focus of new product tests to China, and expanding development of medical equipment and new varieties.

However, the localization process of foreign pharmaceutical enterprises in China is hindered by inadequate or poor quality system, data integrity issue, insufficient validation of many processes in the manufacturing or testing, and adulteration or pollution of products.

According to professionals, foreign pharmaceutical enterprises possess stronger technical superiorities in product R&D compared to Chinese pharmaceutical enterprises, however, they shall strictly control the production process and achieve delicacy management, to set up the leadership superiority in the industry.

Source: PharmNet, Beijing Business Today

Center for Food and Drug Inspection of CFDA issued the Announcement on On-site Checking Plan for Drug Clinical Trial Data No. 11 on April 28.

With a plan to carry out on-site checking on the 39 drugs that have been conducted self-inspection and checking of clinical trial data, including Insulin Degludec Injection (acceptance No.: JXSS1500010, JXSS1500011), etc. (see the attachment for the details), the announcement is hereby publicized for 10 working days, from April 28, 2017 to May 12, 2017.

Pharmaceutical products to receive the on-site checking this time are all from foreign pharmaceutical enterprises including Eli Lilly, AstraZeneca and Novo Nordisk, etc.

Attached: Catalog of varieties to be checked the drug clinical trial data on site

The U.S. Food & Drug Administration (hereinafter referred to as "FDA’) posted a warning letter to China Xiaoshan Plant of Teva Pharmaceutical, an Israeli generic drug giant, on April 10, showing the deficiencies of the plant including failure to monitor the critical process parameters, recurrence of product quality failures, ineffective root cause analysis and CAPA, failure to establish a sampling plan based on scientifically-sound sampling practices, unreasonable process validation sampling, failure to describe how the continued process verification program assures that quality attributes continue to be met batch-to-batch, etc. This was the second warning letter received by Teva in the past 6 months. Before this, FDA has issued a warning letter to the aseptic production factory of Teva in Hungary on October 13, 2016.

The Medicines and Healthcare Products Regulatory Agency (MHRA) announced in 2015 that the Tianjin Factory of GSK was found to not meet EU GMP certification requirements in an unannounced inspection, and the current GMP certificate and previous GMP certificate of the factory were both taken back.

Desires of foreign pharmaceutical enterprises to accelerate localization strategy have become increasingly strong in recent years, and the localization modes have gradually become diversified, including setting up factories in China, upgrading the R&D centers in China, merging Chinese enterprises, and establishing joint ventures with Chinese enterprises, etc.

Some data show that there were 631 patent drugs becoming off-patent in the world in 2012-2016; 18 among the 20 global best-selling prescription drugs are to be off-patent, and the global annual sales of those 18 prescription drugs are USD 142 billion.

As such, foreign pharmaceutical enterprises are seeking changes in their strategies in China to adapt to the new circumstance. Strengthen their concentration and comparative advantage by stripping non-core business; seek new market opportunities by turning their eyes to cultivating the grassroots market; besides joint ventures, foreign pharmaceutical enterprises have begun to strengthen cooperation with local enterprises, and they strive to achieve win-win cooperation through the resultant force of the marketing channel and OEM. Many foreign pharmaceutical enterprises had weak global performance in 2016, but had rapid growth in the Chinese market, therefore, they are competing to build factories in China, shifting focus of new product tests to China, and expanding development of medical equipment and new varieties.

However, the localization process of foreign pharmaceutical enterprises in China is hindered by inadequate or poor quality system, data integrity issue, insufficient validation of many processes in the manufacturing or testing, and adulteration or pollution of products.

According to professionals, foreign pharmaceutical enterprises possess stronger technical superiorities in product R&D compared to Chinese pharmaceutical enterprises, however, they shall strictly control the production process and achieve delicacy management, to set up the leadership superiority in the industry.

Source: PharmNet, Beijing Business Today