In the discussion area of the "ghost market" of the free community of the gene sequencing industry, a friend asked:
It refers to the fact that on May 10, the latest "Classification Catalogue of In Vitro Diagnostic Reagents" released by the State Food and Drug Administration does not contain the "General Kit for Sequencing Reactions".
I happened to have a brief conversation with a friend about this issue some time ago.
Why is this being discussed separately?
Friends in the industry know that the "sequencing reaction general kit" is not a simple class I reagent (before); In many cases, it also carries "more functions" in business cooperation.
When the kit "disappears" in the latest taxonomy, is this "disappearance" temporary, or permanent, a product of an era? How will it be managed in the future? Will a previously filed kit become invalid?
Most importantly, will it affect the business process of each enterprise? Is this the end of the "side-ball" style of play?
The author's ability and information are limited, and this article only makes a brief combing and does not make any deductions. Readers are requested to assess the impact of the incident on their own.
01 The disappearing "Universal Kit for Sequencing Reactions"...
On May 10, 2024, the State Food and Drug Administration issued a new version of the "Classification Catalogue of In Vitro Diagnostic Reagents":
Previously, in 2013, the drug administration issued the "6840 in vitro diagnostic reagent classification sub-catalog (2013 edition)"; This is a major revision after 11 years.
Why revis? Here's what the official said:
"In recent years, with the rapid development of in vitro diagnostic technology and industry, new technologies, new methods, and new targets have been emerging, and the number and variety of products have increased sharply. The 6840 In Vitro Diagnostic Reagent Classification Sub-Catalogue (2013 Edition), Circular 226 and Announcement 112 cannot fully meet regulatory and industry needs, and some product management categories are not fully consistent with the Classification Rules for In Vitro Diagnostic Reagents issued in October 2021. Therefore, the State Food and Drug Administration organized the revision of the Classification Catalog. ”
Before the official release of the 2024 version of the Catalogue, in 2023, the NMPA conducted a public solicitation:
Comparing the Call for Draft 2023 and the Official Draft 2024, you will find:
The "General Kit for Sequencing Reactions" managed by Class I in the Call for Draft 2023 does not appear in the Official Draft 2024.
Looking at the history, the definition of the management classification of "general kit for sequencing reactions" can be traced back to a famous notice (2014) in the history of domestic sequencing:
In this notice, the NMPA clearly defined, for the first time:
- "Gene sequencer" according to Class III medical device management,
- "Sequencing Reaction General Kit" is managed as a Class I medical device;
- Analysis software, as appropriate, is managed by Class II medical devices.
This officially opened the prelude to the standardized management of clinical sequencing products, and has had an impact to this day:
In February 2014, the ban on genetic testing products such as NIPT was opened;
In March 2014, the pilot clinical application of high-throughput gene sequencing was launched.
In June 2014, BGISEQ-100, BGISEQ-1000 and supporting kits were approved for marketing, becoming the first NIPT approved product in China and the first high-throughput gene sequencing clinical diagnostic product approved and registered by the CFDA.
In November 2014, Da'an Gene DA8600 sequencer and NIPT detection kit were approved for marketing;
In December 2014, the list of high-throughput sequencing enterprise pilots and hospital pilots was announced;
....
To sum up, the documents on the classification and definition of "sequencing reaction kits" are sorted out as follows according to the timeline:
02 How many products will be affected?
From the first classification in January 2014 to the "mysterious disappearance" in May 2024, how many universal sequencing reaction kits will be affected in the past ten years?
The answer is: 347.
....
*The full form can be downloaded from the planet of the same name in "Gene Jianghu";
*Sequencing reaction kit for next-generation sequencing included;
- Distribution by ICP filing time:
As can be seen from the figure, before 2023, the number of filings of "sequencing reaction general kits" showed an upward trend year by year, and reached a historical high in 2023.
What happens after the release of the new 2024 category? And it remains to be seen.
(*The first "sequencing reaction general kit" in history has been recorded, and without exception, it has been won by Huayinkang, which has the "first certificate of innovation approval".) ）
- Distribution by filing location:
Beijing, Jiangsu, Guangdong, Hubei and other places have become the highlands for the filing of general kits for sequencing reactions.
03 What are the implications?
It is in the Call for Drafts 2023, but not in the Official Drafts 2024.
The "mysterious disappearance" of the sequencing reaction universal kit must have happened.
Even in July 2023, in the description of the classification and definition of medical device products by the China Institute for Testing and Testing, the general kit for sequencing reactions is still defined as "recommended to be managed as a Class I medical device".
Why "disappear"?
In the notice released at the same time as the official draft of the catalogue 2024, it is written:
(7) The general reagents of the reaction system managed in accordance with the first category mainly refer to the general reagents that maintain the environment of the reaction system during the detection reaction stage. Only reagents with common instrument platforms or methodologies are included, and are not specific to specific test items. It is not possible to separate the complete product for registration/filing.
More explicitly, in the official interpretation released at the same time as the official draft of the catalogue 2024, it is written:
(8) The general reagents of the reaction system managed in accordance with the first category mainly refer to the general reagents that maintain the environment of the reaction system during the detection and reaction stage. Only the reagents of the reaction system that are common to the instrument platform or methodological are included, such as substrate solution for chemiluminescence immunoassay and luminescent solution for chemiluminescence immunoassay, etc., and are not specific detection items. It is not possible to register/record separately after splitting, such as immunodetection reagents, mass spectrometry detection reagents, etc.
A careful reading shows that the "sequencing reaction kit" was renamed as the "gene sequencing reaction kit" by the drug administration, and is no longer recognized as "universal", but is recognized as a "split of the pair", so "it cannot be split into multiple components and registered/filed separately".
So, what is this referring to?
Let's take the whole process of Berry's NIPT project as an example, involving a total of 6 products:
Extraction (Class I), Purification (Class I), Library Preparation (Class III), Sequencing Reactions (Class I), Sequencer (Class III), Analysis Software (Class II):
From the perspective of the experimental process, the "general reagent for sequencing reaction" is sandwiched between two class III products.
According to the official logic, does it mean that "library reagents" and "general reagents for sequencing reactions" will be combined and managed as a "complete product"? (Unknown.) ）
As for whether the previously filed products will be "invalid" after the "delisting", and will it involve re-"registration or filing"?
The official interpretation says this, in particular Article (21):
(20) From the date of issuance of the Classification Catalogue to June 30, 2024, the filing of Class I in vitro diagnostic reagents may be handled in accordance with the original Classification Catalogue; Encourage the filing of Class I in vitro diagnostic reagents in accordance with the "Classification Catalog".
From now on, the first class of in vitro diagnostic reagents shall be filed in accordance with the "Classification Catalog". For Class I in vitro diagnostic reagent products that have been filed before July 1, 2024, the filing person shall refer to the Classification Catalogue for the filing information and filing materials. If it involves the change of filing or cancellation of filing, the filing person shall handle it in accordance with the Announcement on Matters Concerning the Filing of Class I Medical Devices (Announcement No. 62 of 2022 of the State Drug Administration). Among them, if the product category is adjusted from a low category to a high category in accordance with the Classification Catalog, the filing person shall apply to the corresponding drug regulatory department for registration in accordance with the provisions of the Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents and the Classification Catalogue. From January 1, 2027, those who have not obtained a registration certificate in accordance with the law shall not be produced, imported and sold.
(21) If the products that have been registered or filed are not included in the "Classification Catalog", the applicant shall apply for registration or filing in accordance with the relevant provisions in accordance with the classification and definition of medical devices.
It remains to be clarified whether the 347 products that have been recorded, and more products that follow, will be required to re-apply for classification definition.
Write at the back:
When we search for bidding information by "sequencing reaction general kit", we will find a lot of results:
At some point, the "Sequencing Reactions Universal Kit" is even being used as a commercialized "flexible tool".
This time, the "mysterious disappearance" will not only involve changes in the product registration itself, but may even affect the commercialization process of some companies (especially those that do not have any Class III registration certificates).
We will continue to see how it will develop in the future.
Experienced friends are welcome to leave a message to discuss.
Source: Gene Jianghu