Code WHODrug Chinese Products

Vault supports the NMPA-compliant WHODrug Global Chinese for domestic Case and foreign Localized Case processing for China, ensuring coding accuracy and consistency for External Products. When processing an External Product on a Chinese domestic Case, you can browse and code Chinese data using the WHODrug Chinese Search browser.

Upon selecting a code, Vault populates the WHODrug Chinese field with the relevant data, then populates the WHODrug field with the corresponding English data. Similarly, upon coding a WHODrug English product and populating the WHODrug field, Vault populates the WHODrug Chinese field with the corresponding Chinese data. After saving the External Product, Vault maps the Chinese product information to the corresponding Localized Case Product.

When you export the Case to an NMPA E2B(R3) file, Vault maps the following values from the Localized Case Product to the following data elements in the NMPA E2B(R3) report:

• Generic Name: G.k.CN.1 Generic Name 药品通用名
• Registration Holder/Applicant: G.k.3.3 Name of Holder / Applicant

Prerequisites

To code WHODrug Global Chinese products:

• Your organization must maintain a valid WHODrug Global subscription
• Your Admin must enable WHODrug Global Chinese Browser

To auto-code External Products, your Admin must enable WHODrug External Product Auto-Coding.

Code WHODrug Chinese Product Data

In the Case Products section of a domestic Case for China, you can code both English and Chinese WHODrug data to an External Product in the following ways:

• Under the WHODrug Chinese field, select Search WHODrug Chinese () to launch the WHODrug Chinese Search browser and browse product data in Chinese. If the External Product has values in the Product (Reported) and Country Obtained fields, Vault filters product data to those values. Browse for the appropriate product, then select Code.
• Under the WHODrug field, select Advanced Search () to launch the WHODrug Search browser and browse product data in English. If the External Product has values in the English Product (Reported) and Country Obtained fields, Vault filters product data to those values. Browse for the appropriate product, then select Code.
• Depending on your Admin’s configuration, if the External Product has an English Product (Reported) value:
  • Select Auto-code under the WHODrug field to auto-code the product.
  • Select Advanced Search () to launch the Product Browser, then select Launch WHODrug Chinese to launch the WHODrug Chinese Search browser.

After coding a product, Vault maps the Chinese product data to the WHODrug Chinese field and maps the corresponding English product data to the WHODrug field. When you save the External Product, Vault:

• Maps the selected WHODrug product and substance details to the Case
  • When the selected product has multiple substances, Vault creates Substances for each value in the Preferred Name column, to a limit of 1,500 characters, based on the cumulative number of characters across all Substance names
• Maps the selected WHODrug product name and manufacturer details to the corresponding Localized Case Product in Chinese

To remove product details, select Clear Selection from either WHODrug field. When you clear an External Product, Vault:

• Clears the values from both the WHODrug and WHODrug Chinese fields
• Clears any mapping messages
• Deletes all Substances from the External Product after saving

Search Using the WHODrug Chinese Search Browser

After launching the WHODrug Chinese Search browser, you can adjust the search results using the following:

• In the search bar, enter or change the search terms, then select the search () icon to return results based on exact spelling.
  • To filter by country, enter country:[code], where [code] is the ISO three-letter country code. For example, 卡全 country:CHN.
  • To filter by generic drugs only, enter generic:y. For example, 卡全 generic:y.
• To broaden the search results, select one or more of the following Search Columns checkboxes, then enter the appropriate search term and select the search () icon to return results:
  • Preferred Name: Generic names for the product substance
  • Drug Name: Drug trade names
  • Name Specifier: Product name differentiators, such as 注射用
  • UMC MPID: UMC Medicinal Product Identifiers (MPIDs)
  • Drug Code: Alphanumeric drug codes
• To toggle to the English WHODrug Search browser, select the All Actions menu, then select English.

WHODrug Chinese Search Browser Columns

When searching for products in the WHODrug Chinese Search browser, Vault displays the following columns, populated with Chinese data where available:

• Code Options: Select the Code button to apply a product from WHODrug Global Chinese.
• Preferred Name: The generic names for the active product substance or substance combination. Some products may display multiple values separated by semicolons (;) in the Preferred Name column. The first value is the product’s preferred name, and all subsequent values are the product’s substances.
• Drug Name: The brand name under which the product is sold.
• Name Specifier: The product name differentiators, such as 注射用.
• Pharmaceutical Strength: The strength of the active substance in English, per WHODrug Global Chinese standards.
• Pharmaceutical Form: The pharmaceutical form in which the product is sold.
• Country: The country where the product is marketed.
• Country Code: The ISO three-letter country code in English, per WHODrug Global Chinese standards.
• MAH: The Marketing Authorization Holder (MAH) in the country of sale.
• ATC1: The Anatomical Therapeutic Chemical Classification System level one code and a description of the anatomical group.
• ATC2: The Anatomical Therapeutic Chemical Classification System level two code and a description of the therapeutic subgroup.
• ATC3: The Anatomical Therapeutic Chemical Classification System level three code and a description of the therapeutic or pharmacological subgroup.
• ATC4: The Anatomical Therapeutic Chemical Classification System level four code and a description of the chemical, therapeutic, or pharmacological subgroup.
• UMC MPID: The UMC Medicinal Product Identifier (MPID) for the product.
• IDMP MPID: The IDMP Medicinal Product Identifier (MPID) for the product.
• Drug Code: The unique identification code for the drug name and active substances.
• Generic: Whether the product is a generic product.
• Preferred: Whether the product is a preferred brand-name drug.