First, the basic information of drugs
Project background investigation
A brief description of the original, current technology, trend and expected breakthrough of the project.
Product background
Including domestic and international research and development status (time to market, listed companies, progress, main technical problems)
Mainly to understand the listing of drugs in various countries, to understand the reference preparations, drug instructions and so on. , and compare the specifications and indications approved by various countries.
Basic information of the project (mechanism of action, curative effect, safety and dosage form)
Clinical data can query the safety, effectiveness and mechanism of action of drugs.
Latest research information: safety and development trend
Domestic R&D status (number of applications, number of clinical approvals, number of production approvals and manufacturers under development)
Understanding the domestic R&D situation is mainly to inquire about the listing acceptance and conformity evaluation (analyzing opponents), clinical filing (reporting progress and BE difficulty) and CDE API filing, and pay attention to the time node and acceptance type, which helps us to have a general understanding of the project.
The above data can be queried in the database, and the corresponding data can be queried in the drug evaluation database, drug clinical database and global drug listing screening system.
Patent investigation
Patent is one of the cores of pharmaceutical enterprises, and its complexity is very high. On the one hand, patent investigation can avoid infringement, on the other hand, it can also obtain some process parameters from the patent specification for reference. No matter what method is adopted, it is necessary to sort out the information such as the patentee, legal status, patent type and application date.
Patent inquiry, world patent inquiry and China patent inquiry mainly inquire about the patent layout, patent type and expiration date of drugs.
Patent layout: you can inquire about the research situation of the same patent in various countries by inquiring about a drug, and there are specific original patent information in the orange book.
Investigation and study on the establishment of generic drug patents
Drug sales data
Through the drug sales data, we can calculate the input-output ratio and understand the drug market. In the national drug hospital sales data, national sample hospital sales data and sample hospital sales database, you can query the drug sales data and understand the specific data of the drug sales market.
Drug sales data
Registration regulations
This involves too many, CDE registration regulations, as well as domestic and foreign medical related policies.
Of course, there are other processes (prescription research, content research, process preparation research, dissolution research, related substances research, etc.). )
When doing generic drug project research, we should not neglect it. We must make clear the process and the details of inquiry, and then refine it at each stage. I wish you all early success.