Drugdu.com expert's response:

The inquiry of drug registration standards typically involves multiple levels and channels. Here are some suggested methods and avenues for inquiry:

Ⅰ. Methods of Inquiry

Official Website Inquiry:

(1) CDE (National Medical Products Administration's Center for Drug Evaluation) Website: CDE is responsible for the evaluation of drug registration applications, and its website usually publishes information related to drug registration. Through sections such as "Information Disclosure" or "Application Directory Browsing" on the CDE website, you can inquire about the overall acceptance status of drug registration applications and the progress of evaluation and approval. Additionally, CDE provides specific inquiry services for the acceptance, evaluation, and approval progress of drug registration applications, and applicants can inquire through the "Applicant's Window" section.

(2) National Medical Products Administration Website: The National Medical Products Administration is the authoritative agency for drug registration approval, and its website also publishes information and policies related to drug registration. Through sections such as "Drug Registration" or "Information Disclosure" on the National Medical Products Administration website, you can inquire about drug registration standards, registration processes, and related policy documents.

Professional Database Inquiry:

(1) Pharmintelligence Database: This database aggregates official resources from the National Medical Products Administration, Center for Drug Evaluation, and others, comprehensively recording all acceptance numbers and processing statuses announced by the Center for Drug Evaluation, covering various aspects such as domestic new drug registrations, supplementary applications, and imported drugs. Through this database, you can inquire about drug registration information, evaluation status, and evaluation conclusions.

(2) Pharmdata (Pharmdata.cn): Pharmdata provides extensive drug registration information, including drug registration standards, registration processes, and registration categories. Through this database, you can conveniently inquire about drug registration situations and understand registration standards and requirements.

Ⅱ. Steps for Inquiry

(1) Determine the Purpose of Inquiry: Firstly, clarify the purpose of the inquiry, whether it is to understand the registration standards of a specific drug or to understand the overall process and requirements for drug registration.

(2) Select the Method of Inquiry: Based on the purpose of the inquiry, select the appropriate method of inquiry. If it is to understand the registration standards of a specific drug, you can choose to inquire through the official website or professional database; if it is to understand the overall process and requirements for drug registration, you can choose to inquire through the official website.

(3) Enter the Inquiry Page: Based on the selected method of inquiry, enter the corresponding inquiry page. For example, if you choose to inquire through the CDE website, you can enter sections such as "Information Disclosure" or "Application Directory Browsing" on the CDE website; if you choose to inquire through a professional database, you can enter the corresponding database inquiry page.

(4) Enter Inquiry Conditions: On the inquiry page, enter the corresponding inquiry conditions based on the purpose of the inquiry. For example, if you want to inquire about the registration standards of a specific drug, you can search by entering the drug name or acceptance number.

(5) View Inquiry Results: Based on the entered inquiry conditions, view the inquiry results. The inquiry results usually include drug registration information, evaluation status, evaluation conclusions, etc.

In summary, the inquiry of drug registration standards can be conducted through various methods such as official websites and professional databases. During the inquiry process, it is necessary to clarify the purpose of the inquiry, select the appropriate method of inquiry, enter the inquiry page, enter inquiry conditions, and view the inquiry results.