At the DIA 2022 conference in Ottawa, Ms. Myriam Salem, Senior Corporate Regulatory and Enforcement Advisory at Health Canada presented the current practices and future perspectives on the Good Pharmacovigilance Practices (GVP) Inspection Program. The following are the highlights from the session, summarized for your convenience from your PV partners at Zenith PV.
Health Canada GVP inspections resumed in July 2020 leveraging the use of digital technologies. A web portal for sharing documents, ePost Connect was introduced and continues to be in use today. Video conferencing tools to facilitate discussions with MAHs are being used and the overall inspection approach will continue to include Onsite, Virtual, Hybrid while Health Canada is continuously exploring ways to make processes more effective and efficient.
In 2022, HC intends to audit 80 out of the 549 MAHs. Around 15% of MAHs are audited annually and HC employs a Risk-Based Approach for Selecting MAHs for an audit. The major factors used to select Market Authorization Holders for an audit include:
- Information received from the review bureaus in MHPD
- MAH’s compliance history
- Serious ADRs submitted to Canada Vigilance
- MAH’s product portfolio and therapeutic classes associated with higher ADRs
- Conditions imposed on the DINs
- Time since last inspection
The agency also provided a Breakdown of Regulatory observations seen in 2021-22. The most common observations are listed below in actual numbers and as a % of the total.
- C.01.017 Serious Adverse Drug Reactions Reporting 209 (65%)
- C.01.018 Annual Summary Report – 65 (20%)
- C.01.019 Issue Related Summary Report- 17 (5%)
- C.01.020 Maintenance of records – 24 (8%)
- C.08.007/C.08.008 New Drugs (Unusual Failure in Efficacy and Record retention)- 5 (8%)
- C.01.014.21 Terms and Conditions – 1 (0%)
Important Project Updates
The agency also provided a detailed update on the major projects under their current purview. These include:
Use of Artificial intelligence in pharmacovigilance in areas such as case intake processing, Lit screening, Signal Detection, product labels and compliance. The agency concluded that seriousness and expectedness will require human expertise to gauge all factors to evaluate and the use of Human oversight is needed to ensure the AI is not perpetuating a bias from inadequate learning. As the HC position on the use of AI evolves, MAHs are expected to comply with the regulations in the same manner with or without AI.
Compliance monitoring project on CSO-tRMPs As part of the PRMP framework, GVP initiated a Compliance Monitoring Project (CMP) to assess the compliance to Canadian Specific Opioid targeted Risk Management Plans (CSO-tRMPs). The selection of MAHs was made using safety risk-based criteria as well as other criteria such as the type of commitments included in the CSO-tRMPs. The agency intends to complete the inspections and learnings could inform the RMPs implementations.
Compliance of MAHs for lower risk products GVP initiated a pilot project to assess the compliance of lower risk MAHs with GVP using a questionnaire to inform the need for a regular inspection. Lower risk MAHs usually own drugs that are not likely to generate many serious ADRs and for which there is no indicator of poor compliance with GVP. The program objective is to ensure the appropriate level of oversight for MAHs with various levels of risk. The agency intends to complete the inspections, analyze and leverage the results to determine whether this approach could be implemented to all low-risk MAHs.
Mandatory Hospital Reporting of Adverse Drug Reactions As part of the PRMP framework, GVP is planning in collaboration with MHPD and Intelligence Gathering Project (IGP) to determine the current levels of understanding and compliance of Canadian hospitals with adverse drug reaction reporting requirements under Vanessa’s Law. GVP’s role, as part of this project, would be to gather information related to the current documentation of ADRs in hospitals, record retention, internal processes and procedures underlying the reporting of ADRs in order to identify any knowledge gaps and challenges in order to enhance compliance. A questionnaire will be sent to all Health Care Institutions, as defined under C.01.020 (4) across Canada.
GVP Inspection Program- Regulatory Update
The agency commented on the upcoming Agile regulations and its implications for GVP program. These include:
• Risk Management Plans
• Terms and Conditions
To support these agile regulations, policy and guidance currently being updated within the program include:
- Inspection Strategy for Good Pharmacovigilance Practices (GVP) for Drugs (POL-0041)
- Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102)
- Risk Classification of Good Pharmacovigilance Practices (GVP) Observations (GUI-0063)
Zenith PV, your trusted full-service PV partners can set up a call with you to give you a personalized update on the implications of these changes for the PV activities of your company. Please contact us at email@example.com