Regulatory Process
Terms
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- Canadian Agency for Drugs and Technologies in Health
- -provides info for clinical effectiveness and cost effectiveness -CDR (2003): assess drugs for coverage under drug plans
- PMPRB
- -deals with drugs that are patented 1. Regulatory Mandate 2. Reporting Mandate -as part of NPS, also monitors and reports on non-patented (prescription) drugs
- Canadian Expert Drug Advisory
- -independent advisory body of professionals that look at CDR recommendations
- Canadian Optimal Medication and Prescribing Utilization Services (COMPUS)
- -Cdn centre for nationally coordinated info and education on best practices in drug prescribing and use
- Post-marketing Activites
- Monitoring after a drug is approved through surveillance, inspection and investigation
- Adverse Reaction Reporting
- Is post-market surveillance and assessment of a drug's use under real life conditions. It is necessary because clinical trial data (obtained pre-market authorization) may not necessarily reflect real degree of risk to users.
- Adverse Reaction Reports
- Voluntary. Contains info on patient, suspected ass'n b/n product and adverse reaction, and treatment and final outcomes of product use. HPFB keeps confidential the identities of the patient and the person reporting. Reports are to 7 regional Adverse Re
- Med Device Incident Reports
- -manufacturer has both mandatory and involuntary reports to HPBP. Mandatory problem report is required for any incident that takes place a) in Canada or abroad; b) relates to failure of device / deterioration in effectiveness / in adequacy in labelling o
- Getting Word Out on Adverse Reactions
- Canadian Adverse Reaction Newsletter. Advisories. They are attachments to the CMA Journal.
- Getting word out on Adverse Reactions (2)
- MedEffect Website - contains the Health Professional Communications and Public Advisories. There is also a plain language publication called It's Your Health.
- HPBP Compliance Verifications and Investigations
- -minor modifications, to monitoring recalls. HPBP's role is to determine whether corrective action is required; company's role is to determine what corrective action is required and to take the necessary steps; HPFB monitors those actions until it has be
- Compliance Verification Examples
- labelling and advertising violations; product contamination; tampering allegations; product ineffectiveness and product failure; sale of unauthorized products; counterfeit drugs or fraudulet products
- User Fees (3 types)
- 1) Fee to evaluate documentation submitted by manufacturer; 2) fee to maintain marketing rights; 3) fee for an establishmet license.
- Exemption from Fees
- None for clinical trial applications, or HPFB's Special Access Programme. Economic hardship of manufacturer is considered as well.
- User Fees Act (2004)
- -UFA est. a link between performance and new fees + subjects this process to parliamentary oversight. HPBP is developing external charging regime -- includes making sure that its performance standards, reporting and related fees are internationally compa
- International Cooperations and Harmonization
- ICH - International Conference on Harmonization. Reg authorities from Japan, US, and EU. Canada, WHO, and countries of the Euro FTA are observers. They produce technical guidances.
- Common Technical Document (CTD)
- Common format for marketing applications. Purpose is to streamline submission requirements. It should facilitate regulatory communication and improve submission quality.
- e-CTD
- Electronic format for the Common Technical Document. An international electronic standard for regulatory interchange.
- Global Harmonization Task Force (GHTF, 1992)
- Purpose is to encourage the convergence of regulatory practices re MEDICAL DEVICES in diff. jurisdictions; facilitate int'l trade; promote tech. innovation; act as a forum for info exchange.
- HPFB's Collaborative Activies
- MOU with USFDA (2003). MOU with Aus' TGA (2004) - (Therapeutic Goods Administration)
- HPFB - Int'l Collaboration (2)
- WHO - Adverse Drug Reaction Reporting Network. WHO pilot procurement project for securing AIDs; anti-malarial; and TB drugs for use in LDCs. WHO's Traditional Medicines Initiative. Participation in European Pharmacopoeia / US Pharmacopoeia.