Glossary

This glossary was developed to help you understand the terms used in Progressive Licensing Project. It has definitions of terms used throughout the Progressive Licensing Project topic Web pages.

• A
• B
• C
• D
• E
• F
• G
• H
• I
• J
• K
• L
• M
• N
• O
• P
• Q
• R
• S
• T
• U
• V
• W
• X
• Y
• Z

A

Abbreviated New Drug Submission (ANDS)

A manufacturer uses an Abbreviated New Drug Submission to apply for market authorization for a generic drug. The submission needs to demonstrate that the drug is as safe and efficacious as the brand-name drug. See also New Drug Submission (NDS).

Adverse Reaction

An undesirable or unintended effect of a drug that may occur under normal conditions of use.

B

Benefit-Risk Assessment or Evaluation

A method of evaluating the usefulness of a drug for a specific indication, taking into account the benefits and risks associated with that drug under normal conditions of use.

Benefit-Risk Profile

The current interpretation of benefit-risk profile for a drug is a reflection of the overall balance of the product's potential benefits with its identified risks as revealed through the safety and efficacy evidence, and through consideration of how that evidence contextualizes with normal conditions of use on market. As new information becomes available, this can affect the overall benefit-risk profile.

Blueprint for Renewal

A review of Canada's current approach to regulating health products and food with the intent of transforming the legislative, regulatory, and policy frameworks to make Health Canada more efficient, effective, and responsive.

C

Canada Gazette, Part I

The official newspaper of the Government of Canada. Part I contains all public notices, official appointments, and proposed regulations from the Government, as well as miscellaneous public notices from the private sector that are required to be published by a federal statute or by regulations.

Canada Gazette, Part II

The official newspaper of the Government of Canada. Part II contains all regulations that have been enacted as well as other classes of statutory instruments, such as orders in council, orders, and proclamations.

Canadian Reference Product

A marketed drug that is used for the purpose of demonstrating the bioequivalence of a subsequent entry drug.

Clarifax

A request sent to a manufacturer by Health Canada, requesting clarification during the screening and review of an application.

Clinical Trial Application (CTA)

An application made by a manufacturer to Health Canada requesting authorization to conduct a clinical trial in Canada.

Clinical Trial Application Amendment (CTA-A)

An application in which a manufacturer provides new information that updates a previously authorized Clinical Trial Application.

Clinical Trial

An experiment involving human volunteers that is used to determine whether a drug is safe and effective, what dosages are most effective, and what side effects a drug may cause in people.

Compassionate Access

Access to non-marketed or experimental drugs for someone who is gravely ill, with a poor quality of life and at a significant risk of death.

D

"Division 1"--"Old" Drug

Drugs that fall under Division 1 of the Canadian Food and Drug Regulations. Drugs under Division 1 are generally older drugs that have been on the market for a number of years, such as acetaminophen. Often these drugs are available without a prescription.

"Division 8"--"New" Drug

Drugs that fall under Division 8 of the Canadian Food and Drug Regulations (which also include drugs in Division 3 [Radiopharmaceuticals] and Division 4 [Biologics]). Drugs under Division 8 are those that have not been available for a long period of time and for which manufacturers must submit a New Drug Submission (NDS).

Drug

Traditional pharmaceuticals in addition to biologic products, or those derived from living sources.

Drug Identification Number (DIN)

An eight-digit numerical code assigned to each drug product approved under the Food and Drugs Act and Regulations, except for Schedule C drugs (i.e., radiopharmaceuticals, kits, and generators).

Drug Licensing and Regulation System

The process by which drugs are reviewed, evaluated, and licensed by a regulatory body.

Drug Life Cycle

A drug's full "lifespan" from discovery and development, to marketing and ultimate removal from the market.

E

Early Drug Access

Access to certain drugs prior to market authorization because they address an emergency or unmet medical need.

Effectiveness

How well a drug does what it is intended to do under in "real world" circumstances. This is a measure of how well a drug treats the symptoms of a condition when average, everyday patients are taking it.

Efficacy

How well a drug does what it is intended to do under ideal circumstances. This is a measure of how well a drug behave according to controlled scientific expectations when used in clinical trials and drug development.

Emergency Situations

An immediate, urgent, and critical situation of a temporary nature, regardless of its cause, which may seriously endanger or threaten the lives, health, or safety of individuals.

Evidence-based Approach to Decision Making

The use of high-quality evidence to make informed choices. High-quality evidence is scientific, experiential, and includes other types of evidence deemed appropriate.

Extraordinary Needs

Urgent medical need resulting from significant threat to human health, either individual or population-wide.

F

Flexible Departure

Deviation from the standard baseline requirement for evidence supporting a drug's efficacy and safety that is necessary for the drug to attain initial market authorization. There must be a compelling reason justifying such a departure from baseline standards.

Food and Drugs Act

The Canadian federal law that governs the drug and food regulatory system.

Food and Drug Regulations

These regulations, where applicable, set the standards for composition, strength, potency, purity, quality, or other property of the article of food or drug to which they refer.

I

Indication

The reason--such as a condition or disease--identified as justifying the use of a drug.

L

Labelling

All written material associated with a drug, which includes the drug label, the packaging, the patient insert, and the product monograph.

Life Cycle

The entire spectrum of activities that happen over the course of a drug's "life," which includes its discovery; the early testing done to understand the drug; the trials to determine its safety and efficacy in humans; its approval; and its marketing and use in larger populations.

N

Natural Health Product

Vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines, such as traditional Chinese medicines, probiotics, and other products, such as amino acids and essential fatty acids.

New Drug Submission (NDS)

An application made by a manufacturer to Health Canada to authorize a safe, efficacious, and high-quality drug. See also Abbreviated New Drug Submission (ANDS).

Non-clinical Testing Stage

Drug development activities that take place before a drug is tested in human subjects at the clinical testing stage. Such preliminary stages of development include in vitro testing and testing in animals.

No Objection Letter (NOL) for Clinical Trials

This document is issued by Health Canada within the review period if no clinical or quality deficiencies are identified and the Clinical Trial Application (CTA) or Clinical Trial Application Amendment (CTA-A) is deemed acceptable.

Not Satisfactory Notice (NSN) for Clinical Trials

This document is issued by Health Canada if significant deficiencies are identified during the review of the Clinical Trial Application (CTA) or Clinical Trial Application Amendment (CTA-A). The issuance of an NSN can end the review of a CTA.

Notifiable Change

Manufacturers must inform Health Canada of changes to a drug that could adversely affect its safety, purity, potency, or effectiveness.

Notice of Compliance (NOC)

Certifies that a drug complies with the Food and Drugs Act and Regulations. It is issued once Health Canada concludes that the benefits of the drug outweigh the risks, and it confers the ability to market a drug.

Notice of Compliance with Conditions (NOC/c)

Authorization to market a drug intended for the treatment, prevention, or diagnosis of serious, life threatening, or severely debilitating illnesses or conditions, with the condition that the manufacturer undertake additional studies to verify the clinical benefit.

Notice of Deficiency--Withdrawal (NOD/w)

This document is issued by Health Canada if

• the manufacturer fails to submit requested information within the required time period;
• there is unsolicited information; or
• the information is incomplete or deficient.

Notice of Non-compliance (NON)

This document may be issued if the submission does not meet the requirements of the Food and Drugs Act and Regulations. It outlines outstanding issues and may request further information.

P

Pharmaceutical Equivalent

A new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients.

Pharmacogenomics

The identification and study of genes and their corresponding products that influence individual variation in the efficacy and toxicity of therapeutic products, and the application of genomic information to help inform therapeutic product development and clinical application.

Pharmacovigilance

The science and activities relating to the detection, assessment, understanding, and prevention of adverse reactions or any other drug-related problem.

Pharmacovigilance Planning

A proactive approach to identifying risks associated with a product prior to market authorization, as well as to planning for or implementing means to investigate or mitigate those identified risks.

Point-in-Time Drug Licensing

This is a licensing model where the federal role only intersects with drug regulation at defined points in time, such as licensing or withdrawal.

Priority Review

A priority review status assigns eligible submissions a shortened review target of 180 days, in comparison to 300 days for non-priority. This status may be granted to drug submissions intended for the treatment, prevention, or diagnosis of serious, life-threatening, or severely debilitating illnesses or conditions where

• there is no existing drug on the Canadian market with the same profile; or
• the new product represents a significant improvement in the benefit-risk profile over existing products.

Product Monograph

A product monograph is a factual scientific document describing the drug. It is devoid of promotional material and describes the properties, claims, indications, and conditions of use for the drug. It also contains any other information that may be required for optimal, safe, and effective use of the drug

Promising New Therapies

Drugs with considerable evidence to support their potential to address an important therapeutic gap on the Canadian market.

R

Radiopharmaceuticals

Radioactive drugs with diagnostic and therapeutic applications in human health.

Rare Disease

A medical condition that affects a relatively small number of people.

Risk Communications

The dissemination of accurate and up-to-date information about a drug's benefits and risks by Health Canada or a manufacturer, so that consumers can make the best possible decision about the use of a drug.

Risk Management and Mitigation

A term used to collectively describe the activities and considerations involved in addressing and communicating information about health risks. Risk management includes a number of interrelated activities:

• Identifying and analyzing options for addressing the risk;
• Developing and implementing a strategy for managing the risk;
• Monitoring and evaluating the effectiveness of the strategy; and
• Communicating information both about the risk and about the decision-making process.

S

Screening Deficiency Notice (SDN)

This document is issued if deficiencies are identified during screening of a drug submission.

Screening Rejection Letter (SRL) for a DIN Application

This document is issued if a drug is considered a new drug, and hence an NDS is required, and if a proposed ingredient is a prohibited substance, or if a statement within the product monograph is found not to reflect the submission content.

Stakeholder

Individual, group, or organization that is affected by or interested in an issue or policy.

Subsequent Entry Biologic

A biologic product that would enter the market subsequent to, and similar to, an approved biologic from an innovator.

Subsequent Market Entry Drug or Generic Pharmaceutical

Drug that contains the identical medicinal ingredient or ingredients as another drug of that kind that is already on the market in Canada.

Supplemental Abbreviated New Drug Submission (SANDS)

This document must be filed by a manufacturer if changes are made to a drug authorized under an Abbreviated New Drug Submission (ANDS). Such changes may include method of manufacture, labelling, recommended route of administration, or a new indication. See also New Drug Submission (NDS).

Supplemental New Drug Submission (SNDS)

This document is filed by a manufacturer if substantial changes are made to a drug that already has a Notice of Compliance (NOC). Such changes may include method of manufacture, labelling, recommended route of administration, or a new indication. See also New Drug Submission (NDS) and Abbreviated New Drug Submission (ANDS).

T

Thalidomide Tragedy

Thalidomide was a sedative, available to pregnant women in 1959, that was found to be effective in combating many of the symptoms associated with morning sickness. It caused serious birth malformations and the death of thousands of babies internationally. It was ultimately withdrawn from the Canadian market on March 2, 1962.

V

Vulnerable Population

Patient sub-populations who are at enhanced risk for harm resulting from a disease or condition, or by the effects of a drug, such as people with compromised immune systems.

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