The following content is involved in the announcements of relevant matters in the Opinions of the General Office of the State Council on Carrying out Quality and Efficacy Consistency Evaluation of Generic Drugs: pharmaceutical products produced in China with the same production line and approved for marketing in the EU, Japan, or the U.S. can be deemed as passing the consistency evaluation after the review and approval by the Consistency Evaluation Office.

Related:

A Review of the Injection Varieties of the Top 4 Chinese Pharmaceutical Enterprises Exporting to the U.S.

Under the consistency evaluation policy, Chinese pharmaceutical enterprises applying in China after receiving overseas approvals can enter the "priority review" fast track relying on the policy, to surpass other pharmaceutical enterprises in China to pass the consistency evaluation, seize the first chances of the market, and obtain good pricing and competition pattern.

According to the data of Menet, by this June, 6 injection products of Hengrui Medicine: Cisatracurium Besylate Injection, Docetaxel Injection, Irinotecan Hydrochloride Injection, Dexmedetomidine Hydrochloride Injection, Oxaliplatin for Injection, and Cyclophosphamide for Injection, and 5 injection products of Qilu Pharmaceutical: Ondansetron Hydrochloride Injection, Irinotecan Hydrochloride Injection, Oxaliplatin for Injection, Ceftriaxone Sodium for Injection, and Cefepime Hydrochloride for Injection have all been applied for in China through the method of using overseas approval for application in China. All those injection products are expected to be the first to pass the consistency evaluation in China, to enjoy the policy benefits ahead of time, and lay the foundation for future performance growth of the enterprises, before the injection consistency evaluation standards are introduced in China.

Winning the overseas incremental market

The National Healthcare Security Administration of China has recently held a video conference on the Diagnosis Related Group (DRG) payment, to officially announce the list of 30 pilot cities for DRG payment in China, which is called the "ultimate action" for medical insurance expense control in China.

In the context of the increasingly strict medical insurance expense control policy in China, the conflict between the medical service accessibility and expense control will continue to deepen, accompanied by the pressure on the overall growth of the pharmaceutical industry in the future; and we can see that the U.S., the largest generic drug market in the world, is faced with a serious shortage of injection drugs. The synthetic action of the above two factors brings both opportunities and challenges to Chinese pharmaceutical enterprises.

For competent injection manufacturers in China, taking the opportunity of injection product internalization, targeting the high-end regulated market, getting their products to the U.S., the largest generic drug market in the world, and actively seeking new incremental market space will be a great way to meet the challenge of medical insurance expense control in China and keep future growth.

About the author: Xiaowanyan, a pharmaceutical industry practitioner, "word porter" in the era of we media, focusing on the climate changes in the pharmaceutical circle

Keep reading:

A Review of the Injection Varieties of the Top 4 Chinese Pharmaceutical Enterprises Exporting to the U.S.

About  the Author:    

Xiaoyaowan, a pharmaceutical industry practitioner, a word carrier in the We-media era focusing on changes of the pharma industry.

-----------------------------------------------------------------------
Editor's Note:

If you have any suggestion to the content,

please email: Julia.Zhang@ubmsinoexpo.com