Medical net May 24, 2016, nearly a thousand drug companies shut down! 

 

CFDA reported yesterday (23) of the food and drug regulatory statistical yearbook "in 2016, according to the report, by the end of November 2016, the national total of 4176 drug substances and drug products production enterprises. 

 

That is down 889 from 5,065 in 2015. 

 

"In 2016, the number of the pharmaceutical production enterprise and drug substances and drug products enterprises are reduced, this is because the production enterprise licence renewal period, some enterprises due to not through the GMP certification, temporarily not suspended due to the lack of conditions for renewal of the replacement." The CFDA explains in the report. 

 

In recent years, the state has become more and more tightly controlled by GMP. 

 

In addition to the natural replacement, the GMP scope is clearly "shrinking" under the combination of frequent and strict requirements. 

 

On June 3, 2016, published by the state food and drug supervision and management of the administration of the drug inspection report "for 2015, the national agency for production enterprise quality standard inspection situation and problem, according to the report, the drug GMP certification a low pass rate for 3 years, warning letter issued rate for 5 years. 

 

There are two types of inspections involved in the report. A type of routine inspection results, which are based on GMP certification tracking, etc. The other category is the official, "raid", or "fly-in" flight test results of September 1, 2015. 

 

Not only such, publicly reported, according to drug GMP certification in 2015 rectification check rate for 3 years, the agency of the country's most GMP certification inspection task number, 2013, a significant decrease in 2014, only 221 companies for inspection, less than half of the 2013, but the probability of detection problem is just the opposite. 

 

Since 2013, the overall reform of GMP certification has continued to rise, reaching 7.69 percent in 2015 and 3.25 percent in the previous two years and 4.36 percent in the previous two years. 

 

In addition, the proportion of companies receiving letters of caution was the highest in five years, at 30.77 percent, followed by 24.59 percent, 12.65 percent, 17.81 percent and 30.29 percent in 2011-2014. 

 

The results mean that over the past three years, companies have been able to pass a GMP certification once and for all. 

 

Superposition of several heavy market factors include: GMP, and the evaluation of the consistency of input pressure, pressure for marketing changes in two votes, health care and tender and pressure of market access, raw materials such as the cost of pressure, forcing part of drug firms shut down and go. 

 

It is a bold prediction that by 2018 there will be fewer than 5, 000 pharmaceutical companies, up to 4,500. 

 

On May 23, the state administration of drug administration issued the annual report on food and drug administration of 2016. 

 

I. production and business license 

 

The situation of the production and operation of drugs 

 

Drug production approval 

 

As of the end of November 2016, there were 4176 Chinese pharmaceutical and pharmaceutical production enterprises. In 2016, the number of pharmaceutical production enterprise and the number of enterprises have to reduce drug substances and drug products, it is because the production enterprise licence renewal period, some enterprises due to not through the GMP certification, temporarily not suspended due to the lack of conditions for renewal of the replacement. 

 

The drug business license 

 

As of the end of November 2016, there were 465,618 licensed enterprises, including 11,794 corporate and non-legal wholesale enterprises. There are 5,609 retail chains and 220,703 retail chains. The retail unit at 226331. 

 

(4) the production and business license of medical devices 

 

The production license of medical devices 

 

By the end of November 2016, 15343 of the medical device production enterprises, including: 4979 can produce a kind of product enterprises, 8957 can produce 2 kinds of products of enterprises, it can produce three kinds of products by 2366. 

 

The operation license of medical devices 

 

By the end of November 2016, the national total of two, three types of medical equipment management enterprise 335725, among them, only 164634 class ii medical device products of enterprises, only three types of medical equipment products enterprise, 62220, at the same time engaged in two and three types of medical equipment management enterprise in 108871. 

 

The status of approval for registration 

 

(1) health food registration 

 

In 2016, there were 312 initial applications for health food, 738 for change, 143 for technology transfer and 118 for registration. 

 

(2) drug registration 

 

In 2016, the Chinese communist party of China approved the approval of a new drug in the approval of the new drug. A total of 328 clinical applications for the application for a new drug application are approved. 

 

A total of 2,949 clinical applications for generic drugs were approved in 2016 and 207 applications were made. 

 

In 2016, we approved 513 clinical trials for imported drugs and 28 in the market. 

 

In 2016, the general administration of general administration approved 2,560 medicines and 578 medical applications. A total of 5202 approved drugs were approved by the provincial (regional and municipal) bureaus and 16,039 items were put on the record. 

 

In 2016, the general administration approved 782 applications for packaging materials and containers for direct access to pharmaceuticals, and 924 applications for applications and 280 applications. 

 

(3) registration of medical devices 

 

In 2016, the first category of medical devices in China was approved for the record 11,539 units, and the first category of medical devices for imported medical devices was put on the record 3023. Registered within the territory of the second type of medical apparatus and instruments, 6093, the third class registered within the territory of 929 pieces of medical devices, import the second category of registered medical devices (including Hong Kong, Macao and Taiwan) 444, imports of the third class 593 other registered medical devices (including Hong Kong, Macao and Taiwan). Approval in the second category of registered medical apparatus and instruments, 6076, in the third class registered medical device 1510, import the second last registered medical devices (including Hong Kong, Macao and Taiwan) 2077, imports of third class continue 1634 other registered medical devices (including Hong Kong, Macao and Taiwan). The second category of licensing items in the territory has been changed to 3,814 medical devices, and the third class and import (including Hong Kong, Macao and Taiwan) licensing items in the territory have been changed to 1466 medical devices. 

 

Iv. The protection of traditional Chinese medicines 

 

As of the end of November 2016, there were 267 certificates of protection of traditional Chinese medicine, including 120 for the first time, 15 for the same variety and 132 for extended protection period. 

 

The complaint reporting situation 

 

In 2016, the food and drug administration of all levels received 26,966 cases of health food complaints, 640 cases and 705 cases. There were 49354 complaints against drug complaints, 4144 cases and 4,880 cases. The medical device was reported to report 11,693 complaints, 803 cases and 968 cases. 

 

Cases of investigation of the case 

 

2016 food and drug regulators dealt with 3725 cases of health food, value 78.667 million yuan, the fine of $47.864 million, confiscate the illegal income amount is 1.969 million yuan, to ban (investigate) the production and business operation without permission 75, destroying the production and sale of counterfeit goods dens 21, order to suspend production or business operation 97 households, 141 transferred to judicial organs. 

 

2016 food and drug regulators dealt with 96825 cases of drug, value 633.604 million yuan, the fine of $458.217 million, confiscate the illegal income amount is 131.755 million yuan, clamp down on unlicensed operation 1401 households, 188 destroyed the production and sale of counterfeit goods production base, order to suspend production or business 1702, 153 pieces of license, handed over to the judicial authority in 1655. 

 

In 2016, the food and drug administration investigated 457 cases of pharmaceutical packaging materials, with a value of 268,0000 yuan. 

 

2016 the food and drug regulators dealt with 13865 cases of medical apparatus and instruments, value 81.28 million yuan, the fines of 243.34 million yuan, confiscate the illegal income amount is 20.724 million yuan, clamp down on unlicensed business 163, destroying the production and sale of counterfeit goods dens 17, order to suspend production or business 170, 15, license of judiciary authority in 67. 

 

In 2016 with 7673 cases of the food and drug regulator dealt with cosmetics, value 33.478 million yuan, the fine of $36.266 million, confiscate the illegal income amount is 9.505 million yuan, order to suspend production or business 162, handed over to the judicial organs of 26 pieces. 

 

Note: [1] was derived from the food and drug administration statistical reporting system. The data report period is December 1, 2015, solstice, November 30, 2016. 

 

[2] medical equipment production license: the production of both products and production of three categories, respectively when statistical meter for a class of production enterprises and three types of production enterprises, the total number of enterprises only a meter. 

 

[3] medical device operating license situation: the second class and three types of enterprises have their respective categories respectively.