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Year 3 - PPP > 7 - Drug Approval Process > Flashcards

7 - Drug Approval Process Flashcards

1
Q

Generally describe the steps and authorities involved in the process of drug discovery to market

A
  • Molecule discovery
  • Pre-clinical trials
  • Clinical trials (phase 1, 2, 3)
  • Therapeutic products directorate (TPD)
  • Notice of compliance (NOC, NOC/C)
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2
Q

Generally describe the steps and authorities involved in the process of drug pricing and access

A
  • CADTH common drug review (CDR)
  • PMPRB
  • Phase 4 trials, ADR surveillance
  • Formulary decision (provincial)
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3
Q

What is tested in pre-clinical trials from a pharmaceutics point of view?

A
  • Physicochemical characterization
  • Impurity analysis
  • Formulation
  • Stability testing
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4
Q

What is tested in pre-clinical trials from a toxicology point of view?

A
  • Cytotoxicity
  • Hepatotoxicity
  • CV safety pharmacology
  • Maximum tolerated dose
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5
Q

Describe phase 1 of clinical trials

A
  • Establish safe dosing range in humans
  • Use normal, healthy volunteers (20-100)
  • Lasts about 1 year
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6
Q

Describe phase 2 of clinical trials

A
  • Efficacy trials in small population w/ the indicated condition
  • Select optimal dose and observe for AEs
  • Volunteer patients (100-500)
  • Lasts 2-3 years
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7
Q

Describe phase 3 of clinical trials

A
  • Extensive trials in large populations w/ the indicated condition (hundreds to thousands)
  • Goal = verify efficacy of the drug by comparing the new drug to a control group (placebo or comparator)
  • Lasts 1 to 5+ years
  • Sample size is designed to have enough statistical powder to detect difference in the clinical outcomes of interest (NOT adverse effects)
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8
Q

Describe phase 4 of clinical trials

A
  • Post-marketing trials of effectiveness and safety
  • Surveillance of real-word effectiveness and long-term safety
  • New indications for use
  • Special disease-state and populations
  • Drug interaction studies
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9
Q

What is Health Canada’s HPFB (health products and food branch)?

A
  • National authority that regulates, evaluates, and monitors the safety, efficacy, and quality of therapeutic and diagnostic products available to Canadians
  • HPFB also contains TPD (therapeutic products directorate) and BGTD (biologics and genetic therapies directorate)
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10
Q

What is the purpose of the TPD (therapeutic products directorate)?

A

Responsible for evaluating the safety, effectiveness, and quality of pharmaceutical drugs and medical devices available to Canadians

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11
Q

What is the purpose of the BGTD (biologics and genetic therapies directorate)?

A

Responsible for evaluating the safety, effectiveness, and quality of biological and radiopharmaceutical drugs (ex: blood and blood products, viral and bacterial vaccines, genetic therapeutic products, tissues, organs, xenografts)

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12
Q

What is the role of Health Canada in the drug approval process?

A
  • Pre-clinical studies
  • Clinical trial authorization (including clinical trial application or amendment)
  • Submission review (including regulatory product submission, safety, efficacy, and quality review; and market authorization decision)
  • Public access
  • Post-market (including surveillance, inspection, and investigation and post-market changes)
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13
Q

What does TPD do?

A
  • Clinical trial authorization, drug submission reviews, and post-market
  • Reviews scientific info to assess safety, efficacy, and quality of Rx drugs or a medical device
  • Benefit/risk product analysis
  • Reviews clinical trial applications
  • Special access program
  • Provides Canadians w/ science-based medical info they need to make informed choices
  • Monitors evolving safety of drugs in development through review of adverse reaction reports
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14
Q

What must be included in a new drug submission to TPD?

A
  • Safety, efficacy, and quality
  • Pre-clinical and clinical data
  • Drug production
  • Packaging and labelling
  • Therapeutic claims
  • ADEs
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15
Q

Describe the notice of compliance (NOC)

A
  • Permits the sponsor (drug company) to market the drug

- Indicates the drug’s official approval in Canada

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16
Q

Describe the priority review process

A
  • Faster review possible for promising drug products for life threatening/ severely debilitating illnesses (ex: cancer, AIDS, Parkinson’s)
  • Effective tx of a disease or condition for which no drug is presently marketed in Canada
  • OR, a significant increase in efficacy and/or significant decrease in risk such that the overall benefit/ risk profile is improved over existing therapies for a disease or condition that isn’t adequately managed by a drug marketed in Canada
17
Q

Describe the NOC w/ conditions (NOC/C)

A
  • Allows earlier market access for potentially life saving drugs
  • No alternative or significant improvement in benefit/ risk profile over existing products
  • Enhanced post-market surveillance
  • Sponsor agrees to verify the clinical benefit of the drug
  • Increased monitoring and reporting to Health Canada
  • Required to provide educational materials for px and practitioners
  • Public and private drug plans may or may not cover b/c clinical benefit not yet confirmed
  • Conditions removed once satisfactory evidence provided
18
Q

Describe the special access programme (SAP)

A
  • Program operated by Health Canada to give practitioners access to medicines that aren’t approved or otherwise available in Canada
  • Administered by TPD
  • Ability to prescribe drugs w/o NOC to specified px
  • Legitimate need and qualified physician involved
19
Q

What is a patent?

A
  • Legal means of preventing anyone from producing or copying an invention w/o permission of the owner
  • The Act permits the patent holder to prevent third parties from manufacturing or selling any product which uses the invention which is the subject of the patent
20
Q

How long is a patent good for?

A
  • Between 8 and 15 years (average 12 years)

- Market exclusivity depends on length of clinical trial period

21
Q

What are the rules regarding brand name and generic patents and regulatory approval?

A
  • Generic drug firm can’t apply for regulatory approval until brand drug has been on market for at least 6 years
  • Can’t receive regulatory approval until brand drug has been on the market for at least 8 years
  • Applies to “innovative drugs” where the medicinal ingredient hasn’t been previously approved
22
Q

Describe the ANDS (abbreviated new drug submission)

A
  • No clinical trials
  • Bioequivalence studies
  • Only in healthy volunteers in order to reduce the variability not related to differences between products
23
Q

Describe biologic medicines

A
  • Drugs derived through the metabolic processes of living organisms (ex: recombinant DNA, controlled gene expression, antibody method)
  • Important innovations for the tx of many chronic diseases
  • Tend to be more variable and structurally complex than chemically synthesized drugs
  • Costly $$$
24
Q

How are biologics different from conventional pharmaceutics?

A
  • Small molecule vs. big molecule
  • Complex mixtures that aren’t easily identified or characterized
  • Heat-sensitive and susceptible to microbial contamination (requires sterile processes to be applied throughout manufacturing and distribution process)
25
Q

Key differences w/ biological drug reviews

A
  • On-site evaluations -> assessment of production process and facility for a specific product which ensures manufacturing process conforms to info described in the submission
  • Additional GMP (good manufacturing practices) -> special considerations and issues pertinent to manufacturing and control of biological drugs, blood and blood components
26
Q

Describe the PMPRB (patented medicine price review board)

A
  • Independent federal agency that reports to Minister of Health
  • Regulatory mandate = ensure prices charged by patentees for patented medicines sold in Canada aren’t excessive (doesn’t considered “cost-effectiveness” in determining whether prices are excessive)
    • Regulatory process based on scientific review and pricing review
  • Reporting mandate = report on pharmaceutical trends of all medicines and on R & D spending by pharmaceutical patentees
27
Q

Describe CADTH (Canadian agency for drugs and technology in health)

A
  • Reviews new drugs, new combination products, and drugs w/ new indications and provides formulary listing recommendations to all publicly-funded drug benefit plans in Canada (except Quebec)
  • Aims to reduce duplication and maximize use of resources
28
Q

Generally describe the drug formulary review process

A
  1. Health Canada = market authorization
  2. Manufacturer = submission of clinical and economic evidence to CADTH
  3. CADTH = reviews and recommendations to drug plans
  4. Drug plan = listing decision

Year 3 - PPP (8 decks)

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