Skip to main content

Configure product family

In the PV application, under the PRODUCT tab, you can configure a custom library of products known in the industry as the Company Drug Dictionary (CDD), which defines products that meet regulatory requirements and internal reporting obligations for global organizations.

Every company product must belong to a product family. A product family is a group of products that share the same key ingredient and data sheets but can have a different concentration for the active ingredient.

Important

Create separate families or data sheets if products have different core data sheets or their active ingredients differ.

To configure a new product family

  1. In the PV application header, select the PRODUCT tab.

  2. On the page that opens, from the left pane toolbar, select Add Family add_new_icon.png.

    Adding product family
    Figure 1. Adding product family

  3. In the Product Family form that opens, complete configurations as explained in the following table.

    Completing product family details
    Figure 2. Completing product family details

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Status

    Represents the current status of your product family. Upon creation, it is in a draft state. To upgrade the product family, forward the workflow route.

    The workflow of the product family review and approval process can be customarily configured by the EDETEK administrator according to the sponsor's requirements.

    Company Product?*

    Select if the product is under study or is a sponsored product (Yes) or not (No).

    Product Family Name*

    Enter the descriptive product family name, for instance, derived from the active ingredient name or else.

    Comment

    Enter a comment to provide additional information about the product family, if needed.

    SAVE

    Select diskette_icon.png to save the implemented changes.

    Ingredient

    This block is only activated after the product family name is completed and saved.

    Add Record

    Select add_new_icon.png to open the Select Ingredient dialog and select the active ingredient for your product from the list of available ones. For compounded products, for instance, there can be two active ingredients, so multiselect is available for this dialog.

    Selecting ingredient
    Figure 3. Selecting ingredient

    The ingredient(s) configured for a product family are automatically populated to all the products added to this family.

    If the needed ingredient is not available–which is common for investigational products—contact the EDETEK administrator to add it.

    For post-marketing products authorized by the FDA, it is recommended to add active ingredients according to the company labeling information. For example, use the DailyMed or FDA Label websites or obtain accurate information from the regulatory department of your company.

    UNII Code

    Represents the active ingredient code according to the FDA Unique Ingredient Identifier (UNII) terminology to implement the ISO Identification of Medicinal Products (IDMP) standards.

    FDA’s Global Substance Registration System (GSRS) generates UNIIs used in the electronic listing as seen on the DailyMed website. UNII is also used for other regulatory activities throughout product lifecycles. This would encompass clinical trial phases, product marketing, and post-marketing surveillance.

    Ingredient English Name

    Represents the name of the active ingredient in English.

    Ingredient Chinese Name

    Represents the name of the active ingredient in Chinese.

    If the multilingual submission is involved and the relevant Chinese name is unavailable, contact the EDETEK administrator to add it. Currently, only part of the ingredient contains the Chinese name obtained from the Chinese version of the WHODrug dictionary.

    Datasheet

    This block is only activated after the product family name is completed and saved.

    Datasheet Name*

    Enter the name of your data sheet, which contains essential information about a medicinal product, its safety profile, and its intended use.

    Ensure that the data sheet naming rules consistent between different product families, such as IB for clinical, SmPC for EMA post-marketing products, USPI for FDA post-marketing products, and so on.

    Core Datasheet

    Select Yes or No to specify if this data sheet is the main reference for information about a medicinal product, its safety profile, and its intended use.

    Only one data-sheet can be defined as a core for a product family.

    Revision #

    Represents the revision number of the data sheet. The default revision number of the initially created data sheet is 1 and subsequent revisions are automatically incremented when generated.

    Revision Name

    Enter the revision name according to company SOP/WI or customer request.

    Active

    Select Yes or No to specify if this data sheet is active and can be referenced by the system for ICSR processing.

    Active on

    Select Current Date or Other to specify if the data sheet becomes active at the date of the form completion or another date.

    Active Date

    Select the date when the data sheet becomes (has become) active.

    If the Current Date is selected in the Active on field, this field is automatically populated with the current date.

    Include

    Select Yes or No to specify if this data sheet includes another data sheet that can be an additional reference for product details.

    Included Datasheet

    If Yes is selected in the Include field, select the data sheet that you want to include in your main data sheet.

    To add the included data sheet, add one to your product family via the New option.

    Notes

    Enter additional notes related to the data sheet revision number to explain the changes.

    SAVE

    Select diskette_icon.png to save the implemented changes.

    New

    Select plus_icon_gray.png to add an additional data sheet to your product family. You can add as many data sheets as required.

    Terms

    This block is only activated after the data sheet details are completed and saved.

    Add Record

    Select add_new_icon.png to open the MedDRA coding dialog and configure the terminology for the labeled/listed/expected adverse events specified in the data sheet.

    For instance, you can select "flu-like symptoms" if the data sheet specifies that this is an expected adverse event caused by the product.

    You can code your terms using a similar logic as explained in the Autocoding in ICSR forms and Manual coding in ICSR forms sections.

    Coding MedDRA term
    Figure 4. Coding MedDRA term

    PT Term

    Represents the Preferred Term (PT) according to the MedDRA dictionary.

    PT Code

    Represents the code of the Preferred Term (PT) according to the MedDRA dictionary.

    Coding Version

    Represents the version of the MedDRA dictionary that is used to code the term.

    Ensure to keep the MedDRA version the same as used in ICSR that is pertinent to this product family.

    Notes

    Represents notes added to the term upon editing, if any.

Once saved, the product family is configured. Now, if needed, you can forward its route to send it for approval. Once the approval is finalized, you can start configuring products within the family.

In this section:

In the pharmaceutical industry, a medicinal product or drug that is being monitored for its safety and efficacy. A product can be a prescription drug, biologic, vaccine, herbal medicine, or any other health-related product that is used to diagnose, treat, prevent, or alleviate medical conditions in humans.

A document that contains comprehensive and up-to-date safety information about a medicinal product. It is also commonly known as the Summary of Product Characteristics (SmPC) or Prescribing Information in different regions or countries. The PDS/SmPC provides essential details about the product's composition, indications, contraindications, dosage and administration, clinical pharmacology, pharmacokinetics, interactions, adverse reactions, warnings, precautions, and other important safety information.

sponsor's

In pharmacovigilance, the main biologically active component or substance responsible for the therapeutic effect of a pharmaceutical product. The API is the key ingredient in a medication that provides the intended therapeutic benefit. It is also known as the drug substance.

A national regulatory agency that controls the development of new drugs and standards compliance by clinical trial researchers.

Learn more about FDA on the official website.

An alphanumeric identifier linked to a substance's molecular structure or descriptive information and is generated by the Global Substance Registration System (GSRS) of FDA.

ISO

A website operated by the U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a package insert) to health care providers and the general public. The contents of DailyMed are provided and updated daily by the U.S. FDA. The FDA, in turn, collects this information from the pharmaceutical industry.

For more information, visit the DailyMed official website.

A coding service that is used for the unified coding of drugs throughout the pharmaceutical industry. In order to achieve this, the service provides the WHODrug dictionary which is an international classification of medicines created by the WHO Program for International Drug Monitoring. The dictionary is managed by the Uppsala Monitoring Centre and contains drug code numbers, along with related information such as trade names, active ingredients, and additional information, such as marketing authorization, pharmaceutical forms, and strengths of the drugs.

For example, the WHODrug drug code for the substance Ibuprofen is 001092 01 001.

A crucial document that provides detailed information about a medicinal product, including its composition, therapeutic indications, dosing, contraindications, precautions, and the known safety profile. The SmPC is primarily intended for healthcare professionals and is prepared and approved by MAH or a pharmaceutical company and is a legal requirement for all authorized medicinal products in many countries. It serves as the basis for prescribing, dispensing, and administering medication to patients and is an essential reference for healthcare professionals in clinical practice.

A decentralized scientific agency that regulates the evaluation and supervision of the manufacture of medical products in Europe.

Learn more about EMA on its official website.

A document approved by the U.S. FDA and provided by pharmaceutical companies for healthcare professionals in the United States. The USPI is intended to accompany the marketed medicinal product and contains important safety and prescribing information.

The USPI is also known as the package insert in the United States and serves as a comprehensive reference guide for healthcare professionals when prescribing, dispensing, or administering medication to patients. It provides essential information about the drug's indications, dosages, contraindications, warnings, precautions, adverse reactions, drug interactions, and other critical details.

A safety service document that includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product.

sponsor's