Medical network - on April 26, as of April 15, 2017 (the CFDA database update approval to March 22, 2017), 2017, a total of 27 approval from CDE into the list of priority review varieties, involving eight common name, two domestic, import 6. 

 

Then, priority review as a green channel quickly, exactly how much time save drugs coming up? 

 

Speed up! Only need 4 ~ 5 months 

 

From the approved time, priority review speed is accelerated. 

 

 

 

From CDE public time, fastest approved products are mesylate for Mr Bush's, announcement on March 3, 2017, on March 22, 2017 approved. For Mr Bush's piece was published in November 3, 2016 clinical application, this product is the fourth batch of clinical inspection checklist on the products, and at the scene of the drug clinical trial data verification plan announcement (8) list. 

 

Reed longer is phosphoric acid can be used for tablet, citrate method for cloth, murphy, and rui GeFei pills, on October 10, 2016 of the public, on March 10, 2017, it took 5 months. These products are the second batch of products of clinical inspection check list. 

 

CDE into varieties of priority review list released at the earliest date is on October 10, 2016. And before the date of the public has approved products are: on April 4, 2016 approved bayer toluene sulfonic acid sorafenib piece, on May 4, 2016, and on May 10, 2016 approved abbvie Ada wood single injection. Approved after the public products are: on October 25, 2016, approved by the chengdu YuanDong caffeine citrate injection, November 23, 2016 approved Actelion Registration ltd. of McGonagall his capsule, on December 23, 2016, approved by the treatment of qilu and raw materials. 

 

"Double quote" breed 

 

On April 13, CDE announced plans to "priority review of publication of the application for drug registration (15), a total of nine accept order was released, four of them is" the same production lines, has been listed in the United States, apply to domestic listed generics "reason to declare. So far, there have been nine product is synchronization of the European Union or the United States listed reasons to declare priority review, but no product so reason approved listing. 

 

 

 

In fact, the reason is not the final can be attached to priority review list. For example the hydrochloric acid of sichuan hui yu made for kang injection, hainan split and injecting more yesterday galloway sodium for injection with diazepam tora azole sodium, jiangsu XMC fluorine [18 f] deoxidization glucose injection, are not included in the priority review list. 

 

Imported drugs fully unlocked 

 

Imported drugs to speed up not only embodies in priority review in 2017, also in clinical inspection check products approved, in clinical inspection check list and listed the import for the first time in 2017, a total of 11 new drugs approved in the first quarter. 

 

 

 

Thanks to the administration of the state food and drug supervision and administration of imported drug registration management related matters about adjusting decision (draft) ", in view of the CFDA delete "import drug process need to be confirmed after the drugs were allowed in overseas listing and sales can apply for the Chinese clinical trial license" the process, previous backlog is still in the queue to declare imported drugs to market is expected to speed up the approval process. Data from the first quarter of 2017 is approved, you can see that the CFDA is speeding up the imported drugs listed, was in 2015 by clinical verification of the listing of imports declaration may finally be approved. 

 

When this group is the backlog of imported drugs large quantities of listed, the first impact is the original indications of the corresponding market pattern. Such as Mr Bush for his listing will affect the market pattern of non-small cell lung cancer, first SGLT2 inhibitor of column net listing will affect the market pattern of diabetes. Second, 3.1 class declaration by old chemical medicine category related clinical registration strategy, generic product will adjust patent has not expired products still faces challenges. 

 

Looking forward to the < < < 

 

Imported drugs declare backlog problem is expected to be in 2017 years. The CFDA next step will be to solve problems of examination and approval of generics solid oral preparations. Given on April 10, 2017 CFDA open once again on the drug clinical trial data verification issues related to disposal announcement (amended) for advice, with qualitative and processing method of related issues to ensure that the August 2015 clinical inspection check no conclusion domestic products will also be addressed. 

 

With the speeding up of the imported drugs review, batch listed in 2017 a group of domestic listed on the new drug for the first time. Coincided with the dynamic adjustment mechanism is to establish medical insurance directory, these new drugs are expected to conform to the international practice of price negotiation way into health care.