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.

1. Registration application for innovative drugs not yet marketed in and out of China;
2. Registration application for innovative drugs with manufacturing site transferred to China;
3. Registration application for pharmaceutical products with advanced preparation technology, innovative treatment means and obvious therapeutic advantages;
4. Clinical trial application for pharmaceutical products 3 years prior to patent expiration and manufacturing application for pharmaceutical products 1 year prior to patent expiration;
5. 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.
6. Registration application for traditional Chinese medicines (including ethnic drugs) with clear clinical orientation in the prevention and treatment of major diseases;
7. Registration application for new drugs included in National Science and Technology Major Projects or National Key Research and Development Programs;
8. 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;
9. Application for pharmaceutical products that are clinically imperative but short in market supply;
10. First generic varieties;
11. Supplementary application for those required to be changed the approved process and reapplied in the generic drug quality consistency evaluation;
12. 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 drug registration applications to be included in priority review procedure on March 5, 2016, CDE has successively published the list of 15 batches of registration applications to be included in priority review so far (April 13, 2017), involving 213 acceptance numbers in total for 155 varieties among which, there are 23 API applications, and 132 preparation applications: 50 injection applications which are the most and account for 37.8% of the preparation varieties included in priority review, 44 tablet applications which are the second most, and 12 capsule applications which are the third most.

Among the 213 acceptance numbers, 2 are TCMs and 30 are biological products (including 28 biological products for treatment and 2 vaccines), and others are chemical drugs; 155 are new drug application, and the other 58 are generic drug application; 127 are Chinese pharmaceutical products, and 86 are imported pharmaceutical products; 71 are clinical trial application, 133 are marketing application, and 9 are supplementary application.

Characteristics of the 15 batches of pharmaceutical products to be included in priority review:

Seen from the 15 batches of pharmaceutical product registration applications to be included in the priority review procedure published by CDE, the new drugs are mainly the varieties with significant treatment advantages over the present treatment means, pediatric drugs, and infectious disease drugs, such as anti-AIDS and anti-viral hepatitis drugs; the generic drugs are mainly the varieties that have been approved by the Europe and America or have been filed the generic drug marketing application in the Europe and America and passed the U.S. or EU GMP certification.

With regard to varieties with significant treatment advantages over the present treatment means, almost all the publicized 37 items included in the priority review and approval are imported pharmaceutical product, wherein, Osimertinib Tablets was approved by CFDA to be marketed on March 24, 2017 after it was included in the priority review procedure with the help of CFDA’s reform of the pharmaceutical product review and approval system, which has created the record of the shortest time of obtaining approval for imported pharmaceutical product in China.

There are mainly 22 products that have been included in priority review and approval as imperative drugs for children. The 2016 Drug Review Annual Report issued by CDE pointed out that tocilizumab injection, levetiracetam injection and miglustat capsules have all been approved to be imported by the end of 2016. In fact, the 5 pediatric drugs including clofarabine, clofarabine injection, caffeine citrate injection, propranolol hydrochloride oral solution, and faropenem sodium dry syrup for pediatrics have been included in priority review on January 29, 2016 early before CDE formally issued the working procedure for priority review, with the aim to encourage enterprises’ attention to pediatric drugs.