What are the inquiry methods of drug registration review?

There are many ways to query the drug registration review, such as: querying data in CDE and querying data in database. Simply knowing the registration information can directly query data in CDE. If it is to analyze the test difficulty, it can also be used to analyze the test difficulty.

Inquiring about drug registration review mainly includes listing acceptance and consistency evaluation (analysis of opponents), clinical filing (reporting progress and be difficulty) and CDE API filing. For these data, we should pay attention to the time node and acceptance type, and have a general understanding of the project. Here is a brief introduction to CDE official website query and the currently popular database query.

1. Inquire about drug registration and evaluation in CDE official website.

To query in CDE official website, first enter official website, click on the service, and then click on the organization and service rules in the service guide. This is the information we want to know. Click here to check the actual progress of CDE in accepting drug registration applications to the public. No matter whether you are engaged in related work or not, you can inquire by browsing the acceptance catalogue and publicizing new tasks.

Inquiry mode of drug registration review

Back to the information disclosure column, you can see the following accepted varieties. When we input the information of the accepted varieties, we can see the accepted varieties and the varieties being audited. How many varieties, what types and which companies can see now? These data cannot analyze competitors and are difficult to integrate.

Inquiry mode of drug registration review

Two, in the drug registration review database query.

I usually use Rong Yun database to check the drug registration review (analyzing competitors, understanding competition data and judging the difficulty of registration review), and it is also convenient to query, such as "drospirenone ethinylestradiol tablets".

You can query the data in China Drug Evaluation Database under Drug Research and Development, and input "drospirenone ethinyl estradiol tablets" for accurate/fuzzy search. If the "accurate" check box is checked, the search scope will be further narrowed and the search results will be more accurate. You can also retrieve the detailed information of drugs through seven dimensions: target, reference indication, acceptance number, enterprise name, CDE processing date and status start date.

Drug registration review

You can also filter the search results by ATC code, priority review, major projects, special review, consistency evaluation, drug type, application type of acceptance number, application type, registration type, processing status, review conclusion, review sequence and serial number 12. In addition to searching for a single option, you can also search for a combination of multiple options to understand the progress of domestic new drug research and development from different dimensions.

Inquiry mode of drug registration review

The search results cover nine dimensions of data information, such as data volume, acceptance number, drug name, CDE original enterprise name, application type, registration type, undertaking time, status start date and handling status. The data sources are all from authoritative organizations and officials, and the data results have important value and reference significance.

Inquiry mode of drug registration review

Search results can be browsed by acceptance number, by variety and by enterprise, which can quickly analyze opponents and understand the layout of competing tracks.

Browse mode of drug registration review

You can also click Global Analysis to visually display graphical data, including annual trend, drug type analysis, application type analysis, acceptance number application type analysis, drug application top 10 analysis and enterprise application top 10 analysis, so as to understand competing products and analysis data.

Inquiry mode of drug registration review

Click the acceptance number to enter the detailed information page of the drug. The details page provides more detailed and intuitive data information, and comprehensively displays the basic information, review overview, review timeline, other information and related information of drugs. In the Review Timeline column, the review progress is visual, and the results are also visual. In the related information column, the number of articles on this drug collected in other databases is displayed. Click on the database name to jump to the corresponding database and display all the search results containing drug names.

Inquiry mode of drug registration review

The above is how to inquire about the acceptance of drug registration. You can query the application progress and queuing situation of the varieties under research, help users track the progress of domestic new drug research and development in real time, understand the competition pattern of domestic new drug research and development, and grasp the trend of domestic new drug research and development.