39 Pharmaceutical Labeling Terms You Need to Know [Updated for 2023]
The world of pharmaceutical labeling is full of terms and acronyms, and it can be hard to know what they all mean. Here are 39 terms to help you get through 2023 and beyond.
Leverage this guide whenever you need a refresher on important pharmaceutical labeling terms.
Active Pharmaceutical Ingredient (API)
The active ingredient in a pharmaceutical drug or medication. It’s part of any drug that produces the intended effects. APIs are made of chemicals and are often derived from natural sources, such as plants or animals. APIs are used in the manufacturing of finished dosage forms such as tablets, capsules, suppositories, and injections.
Blanket No Changes Certification
Blanket No Changes Certification is an SPL file that serves as a certification that the NDC Codes contained within the file have not changed since the last time they were certified, either through a drug listing or a previous Blanket No Change Certification. The previous drug listing SPL for each product listed in the Blanket No Change Certification file must pass the current SPL validation procedures in order for the Blanket No Change Certification to be accepted. If the product’s previous SPL file does not pass, a full drug listing file must be submitted to FDA with the required updates.
Company Core Data Sheet (CCDS)
A Company Core Data Sheet (CCDS) is an internal document used by pharmaceutical companies to provide a concise and comprehensive overview of a drug product. It contains important information about the product, including its name, active ingredient, formulation, dosage form, indications, and safety information. The CCDS also provides additional information about the manufacturing process, packaging, storage, and distribution of the drug, as well as other relevant details. The document is owned by the marketing authorization holder (MAH) and is updated throughout the drug’s lifecycle. A local label can be derived from the CCDS.
Concept-Level Tracking
Concept-level tracking involves tracking modifications to a label at the most granular level. For instance, if a local market wants to monitor a change in adverse reactions, table formatting and packaging, they must monitor each of these modifications separately. That allows them to report on which changes were implemented as written, which required a content deviation, and which were not implemented at all.
Content Deviation
A content deviation occurs when the language on a local label differs from what is stated on the Common Technical Document (CCDS). For example, the CCDS may describe that the medication could cause one’s hair to become blue, whereas the local authority may prefer wording explaining that the hair could be either blue or green. The pharmaceutical company can then choose whether to make this change for each market where the drug is sold.
A content deviation is a type of label deviation. Continual use of a drug product generates new data, and any discrepancies between this data and the CCDS must be addressed to comply with regulations. Updating the label to accurately reflect the product’s characterization and submitting it is necessary to avoid potential consequences for providing false or misleading information.
DailyMed
DailyMed is a service of the U.S. National Library of Medicine that provides access to up-to-date medication information. It provides a comprehensive database of current medication labels and other drug information, such as package inserts, to healthcare professionals and consumers. DailyMed also provides access to related resources, including drug interactions, prescription assistance programs, and other related materials.
Data Aggregation
Data aggregation is the process of gathering data from various systems to gain an end-to-end view of the label change process and how long it takes to implement a change. This data is sourced from assessment/identification, labeling, artwork, and implementation systems.
Establishment Registration
An establishment registration is a process of registering a pharmaceutical company’s manufacturing facility with the Food and Drug Administration (FDA). This process ensures that the facility meets the FDA’s Good Manufacturing Practices (GMP) standards and that all products manufactured at the facility are safe and effective. To register, a pharmaceutical company must submit an application, provide information about the facility, and pay the applicable fees.
European Medicines Agency (EMA)
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU) tasked with evaluating and monitoring the safety of medicines for use in the EU. The EMA is located in Amsterdam, Netherlands. Its main responsibilities include protecting and promoting public and animal health by ensuring that medicines are safe, effective and of high quality.
Event-Triggered Alerts
Event-triggered alerts help a pharmaceutical company’s management and staff keep on top of items that are soon to be due. If a task is due in a certain number of days, companies can set up alerts to trigger the person who is supposed to be doing the work to remind them.
FDA
The U.S. Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
FDA NDC Directory
An online directory of all drugs, medical devices, and biologics that have been approved by the FDA. It contains information about the product’s National Drug Code (NDC), active ingredients, dosage form, product labeling, and manufacturing information. It also provides links to the FDA’s drug, device, and biologic databases.
FDA SPL Terminologies
The standardized vocabularies and coding systems used to describe the products regulated by the FDA. These terminologies are used to encode drug labeling and other product information in a structured format that is both machine-readable and human-readable. The FDA SPL terminologies include:
Health Canada
Health Canada is the federal department that helps Canadians optimize their health. It performs various functions, such as developing health policies and programs, setting standards for food and drugs, and protecting the public from health and safety risks. Health Canada also provides information about health and safety topics, such as food safety, immunization, and environmental health.
Inactive Ingredients
Inactive ingredients are components of a medication that do not have a therapeutic or active effect on the condition being treated. They are added during the manufacturing process to the active ingredient of the drug to form an end product. Common inactive ingredients include preservatives, diluents, binders, colorants, and flavors.
Instructions For Use (IFU)
Instructions For Use (IFU) are documents typically provided by a manufacturer that provide detailed information on the proper use, maintenance, and storage of a product. This includes the product’s name, purpose, features, warnings, precautions, and any other information that is necessary for the safe and effective use of the product. The IFU may also include a description of the product, additional accessories required for use, and a reference to any related literature or documents. The IFU should be read before using any product and kept with the product in case there are any questions.
Lot Distribution Report
The Center for Biologics Evaluation and Research (CBER) requires biologic drug manufacturers to submit a Lot Distribution Report (LDR) every six months, unless they’re given an annual submission waiver. This report includes data about the bulk, package, and label lots, as well as the bulk manufacturer and the same product elements listed in the drug listing file. It also details all the packages distributed during that period.
Medication Guides (MG)
Medication Guides (MG) are documents that contain FDA-approved information to help patients understand how to take their medications safely and effectively. They provide information on the risks and benefits of the drug, its uses, possible side effects, and other important information. They are typically provided by manufacturers of prescription drugs and can be found in a variety of locations, such as pharmacies and doctor’s offices.
Metadata
Metadata is information about the product that goes beyond the traditional product description. This can include the manufacturer, storage and handling information, expiration date, product identifiers, and more. Metadata is used to ensure that the product is being managed and tracked properly and that it is safe for use.
National Health Surveillance Agency or Agência Nacional de Vigilância Sanitária (ANVISA)
The National Health Surveillance Agency or Agência Nacional de Vigilância Sanitária (ANVISA) is the Brazilian government agency responsible for regulating, controlling and supervising the production, import, export, distribution and use of health products and services. It is also responsible for monitoring and controlling health risks in the country. ANVISA was created in 1999 and is supervised by the Ministry of Health. Its mission is to ensure the safety and efficacy of health products and services in Brazil.
NDC Labeler Code
NDC labeler codes are identification numbers issued by the FDA to pharmaceutical manufacturers and distributors. They are used to accurately identify products, track them for safety and quality control, and for reimbursement and product recalls. NDC labeler codes are assigned to all manufacturers and distributors of prescription and over-the-counter drugs and medical devices. The code acts as the first segment in the product NDC Codes used by FDA to uniquely identify every drug or device product marketed in the US.
Over-the-Counter (OTC) Medicines
Over-the-counter (OTC) medicines are medications that can be obtained without a prescription. These medicines are available for purchase directly from retailers, such as drug stores, supermarkets, and online stores. OTC medicines are typically used to treat minor conditions such as headaches, allergies, and colds.
Patient Package Inserts (PPI)
Patient Package Inserts (PPI) are printed information leaflets that accompany prescription and over-the-counter medications. They provide consumers with detailed information about the proper use, dosage, and side effects of medications. They are also known as Medication Guides.
Pharmaceutical Company
A pharmaceutical company is a business that develops, manufactures, and markets drugs licensed for use as medications. Pharmaceutical companies must adhere to various laws and regulations surrounding drug safey, marketing and more.
Pharmaceutical Label Submission Software
A solution used by pharmaceutical companies when submitting new drug labels for approval by regulatory authorities. It helps to streamline the process of submitting labels by providing an automated workflow that ensures accuracy and timeliness of submission. The software also helps to manage the process of submitting labels for regulatory review and helps to identify potential labeling requirements for different countries. Pharmaceutical label submission software can also help to track the status of label submissions and provide insights into the regulatory process.
Pharmaceutical Label Tracking Software
Regulatory tracking software makes it easier and more efficient for pharma companies to keep up with label changes. It comes with helpful features like custom reporting, a central repository, task automation, quick entry, KPI tracking, audit trails, and customer service, which help regulatory teams make sense of their data and stay in compliance with their projects.
Pharmaceutical Labeling Dependencies
Pharmaceutical labeling dependencies involve dependent and reference markets. Before a dependent market can formally submit a label change to its health authority, it must wait for its reference market to get approval first.
Pharmaceuticals and Medical Devices Agency (PMDA)
The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese government agency responsible for evaluating and approving the safety, efficacy and quality of pharmaceuticals, medical devices, regenerative and cellular therapies and diagnostics. The agency is also responsible for post-marketing surveillance of these products.
Pharmacovigilance Signals
Pharmacovigilance signals are alerts that a drug or medical device may have an adverse effect or unintended effect in some patients. They are detected through the monitoring of patient reports, clinical studies, and other sources. Pharmacovigilance signals can include changes in patient characteristics, reports of adverse events, changes in laboratory values, or any other information that could indicate a potential problem with a medication or medical device.
Pharmacovigilance System Master File (PSMF)
A Pharmacovigilance System Master File (PSMF) is a document or set of documents that provides a comprehensive description of a company’s pharmacovigilance system. It is designed to provide a single source of information that can be used to assess the compliance of a company with the pharmacovigilance requirements of the regulatory authorities. The PSMF includes details of the organization, processes, procedures, and responsibilities of the company with respect to the safety of medicines. It also provides detailed information about the safety data management system and the safety data reporting system.
Prescription Medication
Prescription medication can only be obtained with a written prescription from a doctor or other healthcare professional. It is usually used to treat a specific medical condition.
Regulatory Authority
A regulatory authority is an organization that oversees and enforces the safety and efficacy of drugs, medical devices, and other healthcare products. They are responsible for ensuring that products are safe, effective, and meet standards set by the government. Examples include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada.
Safety Signals
A safety signal, or safety change, is a warning that regulatory authorities, pharmacists, healthcare providers, and patients need to know about right away. When a pharmaceutical company finds out that its drug or medication is causing unexpected side effects, they send out an alert to the relevant authorities.
Structured Product Labeling
Structured Product Labeling (SPL) is a standardized format for electronic drug and biologic labeling information approved by Health Level Seven International (HL7) and adopted by the FDA for the submission of product information to the FDA. SPL documents are used to share information about a product’s labeling and metadata, including ingredients, dosage forms, routes of administration, and storage information. SPL is also used for submitting other required documents to FDA, including establishment registrations and lot distribution data.
Structured Product Monographs
Structured Product Monograph (SPM) is the Health Canada implementation of SPL. Similar to SPL in the United States, SPMs are documents created by pharmaceutical companies that provide detailed information about the approved indications, dosage, contraindications, side effects, and other important information about a specific medication or therapeutic product.
Swissmedic
Swissmedic is the Swiss Agency for Therapeutic Products, the national regulatory authority responsible for the authorization, supervision and control of therapeutic products in Switzerland. Its mission is to ensure that therapeutic products available on the Swiss market are safe, effective, and of high quality. It is responsible for the registration and evaluation of pharmaceuticals, medical devices, and other therapeutic products and for the enforcement of applicable laws and regulations.
Timeline Deviation
A timeline deviation occurs when a pharmaceutical company’s internal SOP for submitting a safety change needs to be shortened or extended.
Wholesale Drug Distributor/3PL Registration
A Wholesale Drug Distributor/3PL Registration is an SPL submission that is required by all businesses that distribute or perform third-party logistics services for pharmaceuticals, including prescription and nonprescription drugs. The registration file includes all license information for all states in which the company provides the relevant services.
XML
XML (Extensible Markup Language) is a document encoding format that provides a set of guidelines for creating documents that are easily readable by both humans and machines. It is used for a wide variety of applications, including storing and transporting data.
Conclusion
These pharmaceutical labeling terms are useful to anyone working in the regulatory space. Let us know if there are any other terms you would like us to cover.
About Intagras
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