Drug research and development and drug technology review are different stages of drug registration, both serving to ensure the safety and effectiveness of drug research and production, but with different service targets. Drug research and development serves drug registration applicants, while drug technical evaluation serves the national drug registration and approval authorities. Both require support from drug registration information.
Drug registration information can generally be divided into: (1) Drug registration regulations and policy information, including the Drug Administration Law, the Implementation Regulations of the Drug Administration Law, the Drug Registration Management Measures, as well as relevant policy documents and guiding principles issued by the National Bureau. (2) Drug application and registration information, including the acceptance and registration of drug varieties, drug review status, drug registration approval status, and the database of drug approval numbers issued. (3) Drug standards and instructions include pharmacopoeia and bureau (department) standards, drug registration standards, and related instructions. (4) Adverse reaction information of marketed drugs. (5) Medical and health technology information, including publicly available journals, magazines, books, etc.
As a drug registration applicant or drug developer, the most concerned thing is whether the declared drug can be approved for registration and when it will be approved for registration. In the project proposal stage of drug development, through information retrieval, one should have a certain understanding of the studied drug and a preliminary estimate of the technical difficulty of the drug research. Whether to pass drug registration is often unclear in my mind. If drug developers can have a relatively comprehensive understanding of the five types of information mentioned above, they can make a judgment on the registrability of the declared drugs.
As a technical reviewer for drug registration, not only do I review the drug registration application materials (including electronic materials) provided by the drug registration applicant, but I also need to have a comprehensive understanding of the drug registration and approval status of the drug or similar related drugs in order to make a technical review opinion on whether the drug can be registered and approved.
At present, drug registration applicants or drug developers can obtain information on drug registration regulations and the applicant's own relevant information from the SFDA website or CDE website; Search the basic database of the SFDA website for information on the approval number of unified replacement drugs and traditional Chinese medicine health drugs; Obtain information about publicly available journals and magazines from relevant websites (such as CNKI, VIP, etc.); Obtain drug standards, adverse reactions, and related technical information from publications related to public or internal distribution.
Now that we have entered the information age and are gradually implementing e-government, there are no technical barriers in the E age. Therefore, strengthening the construction and coordination of information related to drug registration is an urgent task. According to the current principle of government openness, information and technology that do not involve confidentiality should be made public to the society as much as possible, in order to reflect fairness, openness, and impartiality, reduce low-level repetitive research on drugs, and achieve the integration and utilization of social resources.
At present, there are more than 15000 types of marketed drugs produced in China, with over 150000 drug approval numbers and more than 15000 corresponding drug standards. In addition, with the continuous revision or standardization of drug standards, the rectification of local standards has basically come to an end. There is an urgent need for electronic drug standards, the establishment of an information platform for drug standards and instructions, the dynamic management of drug standards, and the convenience of drug registration management and drug testing.
At present, there are many reports that the progress of drug review and registration is slow, and communication between drug review and registration and drug registration applicants is not smooth or timely. Most of the problems are caused by the asymmetry of drug registration information held, so there is no information platform for drug registration, and the dialogue between drug research and development and technical review cannot be discussed. The fairness of the drug review center will be questioned.
One of the important bearers of drug registration informatization is the CDE website, which is also the main user of drug registration information. The Drug Evaluation Center bears the important responsibility of drug technical review and requires strong support of drug registration related information to meet the requirements of "safety, effectiveness, and controllable quality" of drugs. If the CDE website can establish databases or related links in the above five aspects and update them in a timely manner, it can not only reduce the burden on reviewers, improve the quality and efficiency of evaluation, but also ensure the consistency of evaluation requirements for similar varieties, make the evaluation results of similar varieties public, and reduce conflicts between enterprises. The electronic publications published on the CDE website are a good attempt, with good guiding effects, and also an information platform for drug technical review and communication with drug developers.
At present, there is not much content on the CDE website, there are incomplete regulations and corresponding guiding principles related to drug registration, drug standards (departmental or bureau issued standards) and instructions cannot be queried, and there is basically no information on adverse drug reactions, and there are no relevant links established with relevant medical and pharmaceutical websites. Therefore, it is recommended to add and improve relevant content on the CDE website, coordinate with the National Pharmacopoeia Commission, Traditional Chinese Medicine Protection Commission, Drug Evaluation Center, China Institute for the Control of Pharmaceutical and Biological Products, SFDA website, etc., establish a database to achieve resource sharing, and achieve the ideal of everyone serving the Drug Approval Center and the Drug Approval Center serving everyone.
The ideal CDE website should be a drug that needs to be reviewed or queried. After the drug is input, the working computer should display relevant information or links, such as the application, registration and review status of similar varieties, quality standards and instructions of similar drugs, physical and chemical properties of related drugs, enterprises and specifications of similar drug production, requirements of drug registration regulations and guidelines, adverse drug reactions, pharmacological and toxicological reports, etc. Drug technical reviewers can easily conduct reviews. The CDE website believes that technologies or information that do not involve confidentiality should be made public as much as possible or implement a membership system to facilitate the search and use of drug registration applicants and drug developers. At the same time, it also provides assistance for drug research producers in selecting topics and conducting research work, and improves the quality of application materials. Open BBS or drug review forums to discuss and exchange specific or common issues, establish moderators, and answer questions regularly or irregularly.
In summary, drug registration information is the foundation of drug technical review and an important way to communicate with drug registration applicants or drug developers. With the completion of drug registration information work, more participants, and fewer contradictions and difficulties in drug registration technical review work, the Drug Review Center has become everyone's drug review center.