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Configure product

In the pharmaceutical industry, a product refers to a medicinal product 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.

In PV, every company product should belong to a product family that shares the same key ingredient and data sheets but can have a different concentration for the active ingredient. Thus, before adding products, make sure the respective product family is configured in PV.

It is recommended to group your products based on different dosage forms and strengths as follows:

  • For pre-marketing products regulated by the US FDA, since the FDA may allocate a new IND number for each indication, it is recommended to group the product based on different indications even when dosage form and strength are the same. This means that there can be multiple products (for instance, same dosage form, same strength) with different license numbers (IND number).

  • For post-marketing products regulated by Japan PMDA, since PMDA may allocate different J-codes for the same drug formulation, it is recommended to group the product based on different J-codes even when the drug dosage form and strength are the same.

Product differentiation by form and strength
Figure 1. Product differentiation by form and strength

In the preceding schema, you can see that the active ingredient is the same, which is amoxicillin, but there are four different dosage forms of the drug, each of which contains multiple strengths. Thus, ten products need to be configured.

To configure a new product

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

  2. On the page that opens, in the left pane, right-click the product family to which you need to add a product.

    Important

    You can only add products to product families in draft status. Once the product family is sent for review or already approved, you cannot add products to it. To add products to a product family, return the product family route to the Draft status.

  3. From the expanded menu, select Add Product add_new_icon_gray.png.

    Adding product to product family
    Figure 2. Adding product to product family

  4. On the Product form page that opens, complete configurations as explained in the following table.

    Configuring product
    Figure 3. Configuring product

    Tip

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

    Element

    Details

    Product Name*

    Enter the unique product name given to the medication by a pharmaceutical company. Or select WHODrug icon_coding.png to apply WHODrug coding to the existing product.

    Generic Name*

    Enter the generic name that is commonly the name of the active ingredient used universally to identify the medication's chemical composition.

    Dosage Form*

    Select the medication form, for instance, tablet, injection, solution for infusion, and so on.

    Strength

    Enter the amount representing how much of an active ingredient the medication contains.

    For instance, one injection of the medication contains 150 mg of the active ingredient, so in this field, you enter 150.

    Unit

    Select the unit of the medication strength measurement.

    For instance, one injection of the medication contains 150 mg of the active ingredient, so in this field, you select milligrams.

    Strength Name

    Enter the product's strength if it is present in the medicinal product name.

    For instance, for "Discopan 50 mg soft capsules" the strength name is 50mg, and for "Fuldimil 25mg-Filmtabletten"—25 mg.

    WHO Drug Version

    Represents the version of the World Health Organization (WHO) Drug Dictionary used for coding drug information. The field is read-only and populated via product coding.

    WHO Drug Coding Type

    Represents the type of coding used for product creation within PV. The field is read-only and populated via product coding.

    WHO Drug Code

    Represents a unique identifier for a drug within the WHO Drug Dictionary. The field is read-only and populated via product coding.

    WHO MPID

    Represents the WHO medical product identifier, which is a unique number assigned to a drug for identification purposes. The field is read-only and populated via product coding.

    International Birthdate

    Enter the date on which the first regulatory authority that has to approve a particular drug for marketing has done so.

    Development International Birthdate

    Enter the date of first approval (or authorization) for conducting an interventional clinical trial in any country.

    Company Code

    Configure a specific Company Drug Code, such as “Study Drug”, "#VAC", or else.

    Ensure to configure the company drug code according to your company SOP/WI and always keep it consistent. This field can be used as a filter when company product coding.

    Comments

    Enter comments to give more insights into the product details, if needed.

    SAVE

    Select diskette_icon.png to save the implemented changes.

    Once saved, the Product Ingredient block is automatically populated with the ingredient(s) configured for the product family to which this drug belongs.

    Product Ingredient

    Product ingredient information is automatically synchronized from the ingredient of its product family when the product is created (that means only upon the first saving operation for the product record). Here, you need to update only the strength and unit values. Thus, add all the ingredients in the product family before adding products.

    Note that when you delete an ingredient at the product family level, the ingredients of all products that belong to this family are deleted automatically.

    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.

    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.

    Strength Number

    Represents how much of an active ingredient the medication contains.

    This value can be configured upon the product ingredient editing.

    Strength Unit

    Select the unit of the active ingredient strength measurement.

    This value can be configured upon the product ingredient editing.

    Primary Indication block

    Primary Indication

    Select MedDRA Search MedDRA_search_icon.png to code the indication terminology for your product according to MedDRA dictionary.

    Coding MedDRA term
    Figure 4. Coding MedDRA term

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

    MedDRA Coding Type

    Represents the applied type of the MedDRA coding—manual or auto.

    MedDRA 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 the product.

    LLT Code

    Represents the code of Lowest Level Term (LLT) according to MedDRA. The field is read-only and populated via coding.

    LLT Term

    Represents the coded Lowest Level Term (LLT) according to MedDRA. The field is read-only and populated via coding.

    PT Code

    Represents the code of Preferred Term (PT) according to MedDRA. The field is read-only and populated via coding.

    PT Term

    Represents the coded Preferred Term (PT) according to MedDRA. The field is read-only and populated via coding.

    HLT Code

    Represents the code of High Level Term (HLT) according to MedDRA. The field is read-only and populated via coding.

    HLT Term

    Represents the coded High Level Term (HLT) according to MedDRA. The field is read-only and populated via coding.

    HLGT Code

    Represents the code of High Level Group Term (HLGT) according to MedDRA. The field is read-only and populated via coding.

    HLGT Term

    Represents the coded High Level Group Term (HLGT) according to MedDRA. The field is read-only and populated via coding.

    SOC Code

    Represents the code of System Organ Class (SOC) according to MedDRA. The field is read-only and populated via coding.

    SOC Term

    Represents the coded System Organ Class (SOC) according to MedDRA. The field is read-only and populated via coding.

Once saved and the ingredient is added, the new product is configured for the product family. You can now send the product for review and approval by forwarding its route. Once approved, you can use this product data to facilitate ICSR completion, namely, the Product form.

In this section:

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.

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.

The number assigned by the FDA to a clinical trial application for an investigational drug in the United States. When a pharmaceutical company or sponsor intends to conduct clinical trials with an investigational drug in the U.S., they must submit an Investigational New Drug (IND) application to the FDA.

The regulatory authority responsible for the evaluation and approval of pharmaceuticals, medical devices, and regenerative medicine products in Japan. The PMDA is an independent administrative agency under the Ministry of Health, Labour and Welfare (MHLW) of Japan. It plays a critical role in ensuring the safety, efficacy, and quality of healthcare products available in the Japanese market.

A code generally used by hospitals and other medical facilities when they administer non-oral medication to a patient, for example, inhalation solutions, immunosuppressive drugs, and chemotherapy.

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 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.

An internationally used set of terms relating to medical conditions, medicines, and medical devices created to assist regulators with sharing information.

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.

ISO