| Micro-channel |
 |
|
|
|
|
|
| |
| CFDA: four types of medical cases focus on employee reporting bonuses double |
| |
| Author：中國銘鉉 企劃部 Release Time：2017-8-23 11:15:03 Number Browse：702 |
| |
In the latest news on August 23, the state administration of drug administration and the ministry of finance issued a new revised report on the reward for illegal ACTS of food and drug offences (hereinafter referred to as the "measures").
Compared with the documents issued in 2013, the new version of the measures greatly increases the incentive for employees to report the illegal behavior of their enterprises, as well as the protection.
The report bonus was greatly increased, and employees reported double bonuses
The new "measures" set up an internal staff reporting reward mechanism.It is clearly stipulated that internal personnel in the process of development, production, operation and use shall double the amount of reward on the reward standard.In other words, employees report that the medical enterprise is breaking the law and award the prize.
The new measures raise the standard for reporting rewards.The minimum number of rewards for each grade is twice as high, and the reward limit for a single report will be raised from 300,000 yuan to 500,000 yuan.
The new version of the measures also further improved the anonymous reporting rewards, detailing the way and procedures to receive rewards for anonymous reporting.As well as the specific requirements, the pharmaceutical supervision department shall not disclose the relevant information of the informant without the consent of the informant, and the violator will be punished or investigated for the punishment.
Clearly, the new rules will more likely encourage whistleblowing from employees within the medical device industry.The new "measures" have been implemented since the date of promulgation. Can you and your business be ok?
There are 4 kinds of illegal behaviors, and the reward is not less than 300,000
The new version of the "measures" is also clear, with one of the following four conditions, in principle not less than 300,000 yuan for the whistleblower's bonus:
1. Report on systemic and regional food and drug safety risks;
2. The report involves the infant formula, which is included in the national immunization planning vaccine and other varieties, and has caused great harm to the public health or may cause significant harm;
3. The report of intentional adulteration and false selling of counterfeit goods has caused great social harm or may cause significant social harm;
4. Any report of a major social impact identified by the supervision and administration department of the food and drug administration above the provincial level.
That might be a down payment for a house in a second-tier city!
4 types of medical cases, the drug administration will focus on
In addition, in the new "method" published on the same day that drug safety administration publicly released the administration of the opinions on further strengthening the food and drug cases investigation work "(hereinafter referred to as" opinions ").
The opinion clearly stated that "the number of law-enforcement personnel in some areas has decreased over the years and the number of cases seized has declined".
"Opinions" requirement, the case for investigation into the annual appraisal scope of drug safety work, the investigation achievements of the units and individuals rewarded with praise, for lack of case investigation, local protection, the execution paper analyzes serious, criticism, questioning.
The opinion also proposed that the provisions of "penalty to persons" should be strictly enforced.Of illegal punishment according to law is the unit at the same time, to the legal entity, the directly responsible person in charge and other directly responsible personnel penalty, to have a serious violation of natural persons included in the "blacklist", implement the combined punishment.
The state administration of drug administration has issued a strict order requiring drug inspectors at all levels to step up investigations into illegal drug use cases including medical devices.In addition to the new drug law violations, the law will face a more serious situation.
According to the opinion, there are four cases directly related to medical devices to be investigated, including:
1. Registration of medical devices and data falsification cases
2. Production and operation of medical device cases without registration certificate
3. Illegal assembly and renovation of medical device cases
4. Cases involving the production and operation of medical devices without permission
In addition, "through the Internet to sell fake cases" and "false standards, false propaganda cases", also listed as the focus of drug surveillance.
|
| |
Previous article：CFDA post: personal medicine approval, production and marketing release!
Next article：American orphan drug discovery accelerated, China's orphan drug development trend development
|
| |
|
|
