When doing drug project approval, we will compare the marketing status of original research products in various countries, and compare the marketing status of multiple countries to understand the differences in approved specifications and indications, mainly to compare (China, the United States, Japan, Europe) and other countries, where can I check the information on drugs listed in the EU?
It is recommended to use the database for query. The data in the database comes from the official collection and organization, and two databases are formed. One is EMA: EU Centralized Approval Drug Database (approved for marketing by the European Medicines Agency) drugs), one is HMA: EU Mutual Recognition Procedure Drugs (drugs approved for marketing in some EU member states). The following is a brief introduction to the query methods of these two databases.
EU marketed drug data
EU centralized approval drug database
The database contains 1,000 EU EMA (European Medicines Agency) approved for marketing in the EU through centralized procedures +Detailed drug information, public abstracts, instructions and other related documents. The drug authorization number, specifications, dosage form, route of administration, packaging and other information in the authorized product information PDF file are extracted, and basic drug information can be easily obtained. The database is updated in real time and can quickly query important information such as the latest approved drugs and target product approval and registration information in the EU.
Query method for EU centralized approval drug database
Search for keywords through drug name, active ingredient, company, product number, authorization number, dosage form, route of administration, and also through Screening of approval date and update date, conditional screening through ATC code, drug type, market status, fuzzy screening, precise screening, combination screening, advanced search (yes, or, no) and other methods to select EU marketed drug data .
For example: enter "imatinib" in the active ingredient and select generic drugs in the drug type to query relevant drug information. In the search results, you can query and download, drug overview and Drug label information.
For example: enter "imatinib" in the active ingredient and select generic drugs in the drug type to query relevant drug information. In the search results, you can query and download, drug overview and Drug label information.
European Union marketed drugs
Click "drug name" to enter the details page, which contains basic drug information (drug overview, drug instructions, and authorized product information can be downloaded), authorized product information ,Assess historical files and related information.
Marked drug inserts
EU Mutual Recognition Procedure Drug Database
The database contains 40,000 EU HMA (Heads Of Medicines Agency) approved products through the mutual recognition procedure +Detailed drug information, PAR (Announcement Assessment Report), instructions and other related documents.
How to query the EU mutual recognition program drug database
You can query the drug approval date, application type, market status, reference country through drug name, active ingredient, ATC code, company, etc. (RMS), relevant member states (CMS), PAR (Announcement Assessment Report), instructions and other related documents, and quickly search chemical drugs, blood products, vaccines, etc. through screening.
For example: Searching for "torvatan" through drug activity can query the corresponding drug data, and in the search results, you can query and download the drug instruction file.
EU Mutual Recognition Program Drug Database
Click "Drug Name" to enter the details page, which includes basic drug information, relevant member state information, relevant documents, and related information.
Drug name
The above is the way to query the drugs listed in the EU. In addition to querying the drugs listed in the EU, you can also query more than 40 mainstream countries/regions such as China, the United States, and Japan. Marketed drug data.