Review: Which Pharmaceutical Products Have Entered Priority Review? What are the Conditions Required to Enter Priority Review?
Significance of priority review:
Under the circumstances of a huge number of applied varieties and limited review resources, obtaining the right for priority review of enterprises’ pharmaceutical product applications can certainly largely reduce enterprises’ queuing time for approval and overall registration cycle, and create favorable conditions for enterprises to gain the marketing time; the priority review is also conductive to solve the clinical demands, especially of great significance to making sure the registration applications of new drugs with significant clinical value and clinically imperative pharmaceutical products to timely obtain the marketing approval; it can also encourage enterprise independent innovation and contribute to the rapid development of Chinese pharmaceutical industry.
Conditions for current Chinese pharmaceutical product registration applications to be included in priority review and approval:
In accordance with CFDA’s Opinions on the Implementation of Priority Review and Approval to Resolve Backlogged Drug Registration Applications issued on February 26, 2016 and Working Procedure for Priority Review of Center for Drug Evaluation (Trial), and CDE’s notice on seeking opinions on Basic Principles for the Implementation of Priority Review of "First Generic" Varieties issued on July 21, 2016, for pharmaceutical product registration applications meeting any of the following circumstances, the applicants can file the applications for priority review and approval to the Center for Drug Evaluation (CDE), for CDE to organize experts to conduct review and demonstration, to publicize undisputed registration applications included in priority review procedure and give priority to arranging review for them.
- Registration application for innovative drugs not yet marketed in and out of China;
- Registration application for innovative drugs with manufacturing site transferred to China;
- Registration application for pharmaceutical products with advanced preparation technology, innovative treatment means and obvious therapeutic advantages;
- Clinical trial application for pharmaceutical products 3 years prior to patent expiration and manufacturing application for pharmaceutical products 1 year prior to patent expiration;
- Clinical trial application for new drugs which have been applied in parallel and approved the clinical trial in the U.S. and EU; registration application for pharmaceutical products which are manufactured in the same manufacturing line in China, and have been applied in parallel for marketing with the U.S. and EU pharmaceutical product approval institutions with manufacturing site inspection approved.
- Registration application for traditional Chinese medicines (including ethnic drugs) with clear clinical orientation in the prevention and treatment of major diseases;
- Registration application for new drugs included in National Science and Technology Major Projects or National Key Research and Development Programs;
- Registration application for the pharmaceutical products that prevent and treat the following diseases and have significant clinical advantages: AIDS, tuberculosis, viral hepatitis, rare diseases, malignant tumors, pediatric drugs, and diseases peculiar to and prevalent in the aged;
- Application for pharmaceutical products that are clinically imperative but short in market supply;
- First generic varieties;
- Supplementary application for those required to be changed the approved process and reapplied in the generic drug quality consistency evaluation;
- Re-application for generic drugs which are included in self-inspection for clinical trial data of drugs, but withdrawn by applicants and thereafter improved according to the criteria of quality and efficacy consistency to original drugs.
Review: 15 batches of drugs to be included in priority review procedure publicized by CDE
Since it published the first batch of dru...
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