Drug Development Process

Drug Development Process

The series of stages a drug goes through from initial discovery to market availability.

Preclinical Studies

Initial research, often in laboratory settings and using animal models, to assess the safety and efficacy of a potential drug before it is tested in humans.

Clinical Trial Application (CTA)

An application submitted to regulatory authorities (like Health Canada) to request permission to begin testing a new drug in human clinical trials.

No Objection Letter (NOL)

Approval from regulatory authorities allowing a clinical trial to proceed after review of the CTA.

Phase I Clinical Trials

The first stage of human testing, usually involving a small group of healthy volunteers, to assess the drug's safety, tolerability, and pharmacokinetics.

Phase II Clinical Trials

The second stage of human testing, involving a larger group of patients with the target disease, to evaluate the drug's efficacy and further assess its safety.

Phase III Clinical Trials

The third and typically largest stage of human testing, involving a large number of patients across multiple sites, to confirm efficacy, monitor adverse effects, and compare the new drug to existing treatments or a placebo. These can be further divided into IIIa and IIIb.

New Drug Submission (NDS)

A comprehensive submission to regulatory authorities containing all the scientific information about a drug's safety, efficacy, and quality, seeking approval to market the drug. This includes preclinical and clinical results, manufacturing details, and proposed labeling.

Therapeutic Products Directorate (PDD)

The branch of Health Canada responsible for reviewing and regulating pharmaceutical drugs for human use.

Health Products and Food Branch (HPFB)

The branch of Health Canada that includes the PDD and regulates health products and food.

Summary Basis of Decision (SBD)

A document made accessible by Health Canada that provides information about the reasons for the approval or rejection of a new drug submission.

Notice of Compliance (NOC)

Official authorization issued by Health Canada if a drug is deemed to have benefits that outweigh its risks, allowing the drug to be sold in Canada. A Drug Information Number (DIN) is also assigned.

Drug Information Number (DIN)

An eight-digit number assigned by Health Canada to each drug product approved for sale in Canada.

Notice of Non-Compliance (NON)

Official notification from regulatory authorities indicating that a new drug submission has been rejected, often with a timeframe for the manufacturer to respond.

Patent Protection

A period of exclusivity granted to the manufacturer of a brand-name drug, preventing generic competition for a certain time. In Canada, this can be up to 17 years from patent issuance or 20 years from filing.

Pricing Review

The process in Canada where the Patented Medicine Prices Review Board (PMPRB) reviews the prices of patented drugs.

Phase IV Clinical Trials (Post-marketing Surveillance)

Studies conducted after a drug has been approved and is on the market to monitor its safety and effectiveness in real-world settings with a broader patient population.

Supplemental New Drug Submission (SNDS)

A submission made by a manufacturer to request changes to a drug that has already been authorized for sale, such as new indications or formulations.

Abbreviated New Drug Submission (ANDS)

The submission process for generic drug companies in the U.S. (similar processes exist in Canada), which requires less information than a full NDS but must demonstrate bioequivalence to the brand-name drug.

Generic Drugs

Copies of brand-name drugs that contain the same active ingredient, dosage form, strength, route of administration, and intended use, and must demonstrate bioequivalence.

Natural Health Product (NHP)

A category of health products in Canada that has a separate regulatory pathway from pharmaceutical drugs.

Natural Product Number (NPN)

An eight-digit number assigned by Health Canada to each natural health product approved for sale in Canada.

Natural and Non-Prescription Health Products Branch (NNHPD)

The branch of Health Canada responsible for regulating natural health products and non-prescription drugs.

Bioequivalence

Two different drug preparations with equal dosage form produce similar pharmacokinetic measures.

Drug Withdrawal

The removal of a drug from the market due to safety issues, lack of efficacy, or other reasons.

Investigational New Drug (IND)

The equivalent of a CTA in the United States.

Notice of Compliance with conditions (NOC/c)

An NOC issued with conditions, indicating that while the drug has shown promise, further studies may be required to confirm its benefit-risk profile.

Exceptions for phase I

first time administered in humans, anticancer agents, HIV drugs

Patent act

manufacturs of the brand name have 17 years of patent protection from the date the patent was issued or 20 years from filing date

Patented Medicine Prices Review Board

regulates the manufacturers prices of the patented medicines to ensure they are not excessive by reviewing the factory gate price

natural health product examples (6 things)

• vitamins and minerals- herbal remedies-homeopathic meds-traditional med-probiotic -amino acid and essential fatty acid

Excluded sustances from NHP (4 things)

biologics, injectables, tobacco, marijuana

traditional health claims

Claims based on the sum total knowledge and practice based on experiences indigenous to a specific culture used to maintain or treatment of health. at least 2 generations of use

Special Access Programme (SAP)

Canada allows practitioners to request access to drugs that are unavailable for sale in Canada for patients with serious or life-threatening conditions when conventional therapies have failed