7 - Drug Approval Process Flashcards
Generally describe the steps and authorities involved in the process of drug discovery to market
- Molecule discovery
- Pre-clinical trials
- Clinical trials (phase 1, 2, 3)
- Therapeutic products directorate (TPD)
- Notice of compliance (NOC, NOC/C)
Generally describe the steps and authorities involved in the process of drug pricing and access
- CADTH common drug review (CDR)
- PMPRB
- Phase 4 trials, ADR surveillance
- Formulary decision (provincial)
What is tested in pre-clinical trials from a pharmaceutics point of view?
- Physicochemical characterization
- Impurity analysis
- Formulation
- Stability testing
What is tested in pre-clinical trials from a toxicology point of view?
- Cytotoxicity
- Hepatotoxicity
- CV safety pharmacology
- Maximum tolerated dose
Describe phase 1 of clinical trials
- Establish safe dosing range in humans
- Use normal, healthy volunteers (20-100)
- Lasts about 1 year
Describe phase 2 of clinical trials
- Efficacy trials in small population w/ the indicated condition
- Select optimal dose and observe for AEs
- Volunteer patients (100-500)
- Lasts 2-3 years
Describe phase 3 of clinical trials
- 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)
Describe phase 4 of clinical trials
- 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
What is Health Canada’s HPFB (health products and food branch)?
- 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)
What is the purpose of the TPD (therapeutic products directorate)?
Responsible for evaluating the safety, effectiveness, and quality of pharmaceutical drugs and medical devices available to Canadians
What is the purpose of the BGTD (biologics and genetic therapies directorate)?
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)
What is the role of Health Canada in the drug approval process?
- 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)
What does TPD do?
- 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
What must be included in a new drug submission to TPD?
- Safety, efficacy, and quality
- Pre-clinical and clinical data
- Drug production
- Packaging and labelling
- Therapeutic claims
- ADEs
Describe the notice of compliance (NOC)
- Permits the sponsor (drug company) to market the drug
- Indicates the drug’s official approval in Canada