122 drafts of detailed rules for personal legacy: Create an all-round supervision and inspection system!

On March 22, the Ministry of Science and Technology issued a notice on the public solicitation of opinions on the Detailed Rules for the Implementation of the Regulations on the Management of Human Genetic Resources (Draft for Comments) (hereinafter referred to as the Draft for Comments)

E-pharmaceutical managers gathered multiple voices and found that on the whole, everyone agreed that the release of the draft rules reflects two trends in the management of human heritage resources in my country:

On the one hand, refine and optimize some processes to make the front-end review more scientific and reasonable

On the other hand, the importance of compliance is emphasized

Industry insiders agree that the arrangement based on relevant clauses has paved the way for the normalization, standardization and random inspection of future inspections

Industry insiders have also noticed that the draft of detailed rules emphasizes the protection of professional science and clarifies the responsibilities of experts.

The draft of detailed rules also mentions the construction of digital platforms and the investigation and registration of genetic resources.

On the whole, the main idea of ​​the detailed rules is to improve the self-discipline of the industry and strengthen the management and control of key links

01 Human heritage resource information, more focus on gene and genome data management

Previously, the most headache and confusion in the industry regarding the information of human heritage resources was how to understand the scope of “information” of human heritage resources

However, industry analysts believe that the management is actually gradually clarifying from various levels and different channels, and the future "human heritage resource information" must be more focused on gene and genome data

First of all, in the answers to the common questions about human remains issued by the Ministry of Science and Technology on March 2, the Human Remains Office has made it clear that it only collects data that does not contain information on human genetic resources, and is not within the scope of management

In fact, in the Human Heritage Management Regulations, the definition of information refers to: the information generated by the use of human genetic resources, without emphasis on human genes or genomic data

However, in the draft of the detailed rules, two keywords, human genes and genomic data, are added

It can be seen that the management is making it clear to everyone in various ways that the information on human genetic resources is more focused on genes and genome data

There is also related information related to the sample, which the industry is very concerned about, such as some image data, and some basic information of patients.

Although it is not clear in the draft of the detailed rules, industry insiders believe that, based on the analysis of the draft of detailed rules, various types of samples containing tissues and organs and human remains are the samples of human genetic resources.

02 Clarify the identification of foreign units, and some enterprises will be re-identified as Chinese units

The identification of the identity of foreign entities is also one of the most concerned issues in the industry

Previously, many companies in the industry with more or less foreign elements were basically managed as foreign entities
.
According to the draft rules, foreign entities refer to overseas organizations and institutions established or actually controlled by overseas organizations and individuals
.
The People's Relics Office clarified the three actual control situations it identified:

(1) Overseas organizations or individuals hold or indirectly hold more than 50% of the shares, equity, voting rights, property shares or other similar rights and interests of the institution;

(2) Although the shares, equities, voting rights, property shares or other similar rights and interests of the institution held or indirectly held by overseas organizations or individuals do not reach 50%, the voting rights or other rights and interests they enjoy in the decision-making body are sufficient to make decisions on the institution.
Or have a significant impact on the decision-making and internal management of the institution;

(3) The agreement or other arrangement of an overseas organization or individual is sufficient to exert a significant influence on the decision-making, operation and management of the institution and other major matters
.

Among them, the biggest impact on enterprises is that enterprises find that, in addition to traditional equity control, the method of controlling by agreement, the more typical VIE structure, will fall into the category of actual control
.
That is, the main body of the VIE may be identified as a foreign entity
.

However, industry insiders believe that, from the past practice of genetic office, in fact, the main body of VIE may always be regarded as a foreign unit actually controlled by a foreign party
.
Now it is only further clarified in written form in the draft of detailed rules
.
This also means that after the implementation of the detailed rules, if the enterprise is officially recognized as a foreign entity, the specific impact on its business must be considered
.

However, the situation that enterprises with foreign capital will be identified as foreign units is expected to change
.
According to the actual control standards mentioned in the draft rules, a local biopharmaceutical company with foreign parties holding less than 50% of the shares and having no significant impact on the company's internal decision-making or management will be re-identified as a Chinese company.
This is a big plus for them
.

However, what arouses the doubts of enterprises is under which circumstances, it is considered that there is no significant impact on the decision-making of enterprises or the lack of management of content.
There is also a lot of room for discussion, which is worth further clarification
.

03 Simplify the filing and refine the changes of the national alliance to further accelerate the registration of clinical trials

A number of simplified filing procedures for registered clinical trials have also been introduced in the draft of detailed rules
.
Previously, some registered clinical trials could be simplified and filed
.
However, its filing scope is relatively limited.
For example, in addition to the fact that human remains cannot be exported, it is also required that samples collected in hospitals must be tested in the hospital, or tested by a testing unit commissioned by the hospital
.

However, in practice, especially for multi-center clinical trials, it is difficult to entrust the hospital or the hospital to conduct the test itself, which leads to many registered clinical trials in practice, and it is difficult to meet the filing requirements
.

Industry insiders believe that the draft rules seem to respond to this difficulty
.
The draft of the detailed rules no longer emphasizes that the testing must be commissioned by clinical institutions, i.
e.
Chinese hospitals, but instead points out that testing, analysis and processing of the remaining samples can be carried out by domestic units designated by the clinical trial plans for the marketing authorization clinical trials of relevant drugs and medical devices.

.

In this regard, industry insiders interpret that this means that the testing unit designated by the clinical trial plan can also go through the filing process
.
If you can go through the filing process once, this will be a great benefit to the declarer
.

On the one hand, compared with the approval process, the pass rate of the filing process is very high, close to 100%
.
On the other hand, the time of the filing process is relatively predictable, and it can basically be passed within 1-2 months
.

This not only enhances the time predictability of registered clinical trials, but also helps relevant institutions to arrange the rhythm of clinical trials, especially in multi-center clinical trials around the world, which will greatly facilitate clinical trials in China and international coordination as soon as possible
.

In addition, for international cooperation projects that cannot go through the filing route but require approval, if there are minor changes in the middle, it is also expected to be implemented faster
.

According to the setting of the draft of detailed rules, the changes of the international cooperation license are divided into major changes and non-major changes
.
Regarding non-major changes, if the research protocol is allowed to remain unchanged, only the changes involving the cumulative number of cases not exceeding 10% of the approved number can be regarded as non-major changes
.
Before, even if there were more than one case, changes were required
.

If it is a non-major change, the applicant only needs to submit the explanatory materials and make a report to immediately implement the change, which means that the applicant does not need to suspend the clinical trial and continue after the process.
Going smoothly is also very beneficial
.

In addition, the relaxation of the number and types of collection approvals has been strengthened, which will also help the implementation of clinical trials
.
In the draft of the detailed rules, it is clearly stated in the important genetic family that the collection and approval of families with common polygenic diseases is not within the scope of future approval, and the collection and approval of rare diseases has also been cancelled in the category
.
The prescribed number has been relaxed from the original 500 cases to 3,000 cases, which means that the collection approval is mainly based on large-scale population research
.

It is worth noting that it emphasizes that the clinical research conducted for the listing of related drugs and devices, the collection activities involved are not within the scope of collection approval, which means that if an enterprise conducts clinical research for the purpose of registration, it is No separate application for collection approval is required
.
Industry insiders believe that the collection and approval in the future is actually a very small scope, and it also reflects the idea of ​​management and control of key links in the People's Survival Office
.

At the same time, the overlapping and duplication of approvals for collection and preservation, which has long plagued everyone, has also been resolved
.
As mentioned in Article 37 of the draft rules, if there are licensed items that have been deposited, there is no need to apply for a collection license for this part of the sample
.
This also requires the preservation unit to strengthen management to ensure that the preserved human genetic resources are collected in accordance with laws and regulations
.

04 Create a comprehensive and normalized supervision and inspection system to strengthen corporate compliance awareness

Looking at the draft of 122 detailed rules, 71 of them are to clarify some matters and relax some standards
.
However, 51 articles are related to supervision and inspection and administrative penalties
.

Industry insiders agree that the draft rules have established a risk-graded, comprehensive and normalized supervision and inspection system
.

The draft of the detailed rules proposes that the provincial science and technology management departments and relevant regional departments should strengthen the localized management work in the region, including daily management and supervision of resource investigation, investigation and punishment of illegal cases and other related matters
.

In addition, the provincial level and the relevant regulatory departments of the Ministry of Science and Technology are also equipped with regulatory forces, and if necessary, auxiliary law enforcement assistants can be hired
.
This also means that in the future, both the system and the supervision force will be greatly improved
.

It is worth noting that the draft of detailed rules clearly proposes four inspection categories
.

For example, regular inspections refer to national and local plans for a regular inspection period every year; key inspections are mainly risk-based inspections.
For example, if the Ministry of Science and Technology believes that there are suspected violations in the past and have been punished, there are violations and compliance issues that have not been rectified in time.
, or other, companies that do not comply with the regulations in place will increase the frequency of supervision and inspection, and carry out key inspections; random supervision and inspection are equivalent to irregular random inspections; special supervision and inspection are generally in the case of serious illegal behavior, or when it is a temporary emergency, it will be carried out
.

In addition to increasing inspections, industry insiders pointed out that if the compliance system is well done and there are no compliance problems, the number of supervision and inspections is expected to be reduced
.
This also means that companies that do better will face less compliance pressure and inspection pressure in the future, and companies that are relatively lacking and not in place may face greater inspection pressure
.

By creating a comprehensive regulatory system, the Genetics Office is also encouraging everyone to improve their own compliance system
.
It is foreseeable that inspections will be the norm in the future, and companies should be prepared to deal with them
.
If the enterprise has some historical compliance problems, or finds some compliance flaws, the enterprise should not take chances, but should correct its attitude, actively rectify, and try to eliminate the relevant impact.
This can reduce or reduce the risk of administrative penalties for the enterprise, or Responsibility would be more beneficial
.