Safety report is a collection of Vigilance data that helps competent authorities and NBs in determining the risk-benefit ratio of a medicinal product concerning the global safety norms. The data collected through these reports help both patients and healthcare professionals in retrieving the necessary updates.
For different countries, based on risk classification, reporting period changes. Coming to the content of these reports, there’s lot of overlap between different countries. So not just doing individual reports, MakroCare has standardized templates that can be used across countries and get synergies well to save time and costs
With MakroCare for Safety reports:
Get your necessary templates and procedures developed- Plan and perform continuous Signal detection
- Led by safety physicians, resources are pooled globally to match speed and cost of these reports
- We use proprietary Authoring tools to ensure consistency and efficiency
- In addition, our teams can also perform Evaluation of the risk-benefit ratio to update in these reports
- Cross-functional teams with deep experience in Safety areas
Some Requirements across regions/countries:
EUROPE / EU MDR
Class I
PMSR
As Requested
As per Need
Class IIa
PSUR
NB Reviewed for Conformity
Every 2 years
Class IIb (Non-Implantable)
PSUR
NB Reviewed for Conformity
Annually
Class IIb (Implantable)
PSUR
EUDAMAD/ NB Reviewed for Conformity
Annually
Class III (Implantable)
PSUR
EUDAMAD/ NB Reviewed for Conformity
Annually
IVD Class A,B
PMSR
As Requested
As per Need
IVD C
PSUR
NB Reviewed for Conformity
Annually
IVD D
PSUR
EUDAMAD/ NB Reviewed for Conformity
Annually
CANADA
Class I
Summary Report
Not Required
Not Required
Class II
Summary Report
Health Canada
Every 2 years
Class III
Summary Report
Health Canada
Annually
Class IV
Summary Report
Health Canada
Annually
IVD Class I
Summary Report
Not Required
Not Required
IVD Class II
Summary Report
Health Canada
Every 2 years
IVD Class III
Summary Report
Health Canada
Annually
IVD Class IV
Summary Report
Health Canada
Annually
USA
Class I
PSURs/ PBRERs or PADERs/PAERs
Not Required
Not Required
Class II
PSURs/ PBRERs or PADERs/PAERs
US FDA
As per standard US requirements every 3 months for two years and then yearly forever. As per ICH (or EU) timing, then the 3 month and annual reports.
Class III
PSURs/ PBRERs or PADERs/PAERs
US FDA
As per standard US requirements every 3 months for two years and then yearly forever. As per ICH (or EU) timing, then the 3 month and annual reports
IVD Class I
PSURs/ PBRERs or PADERs/PAERs
Not Required
Not Required
IVD Class II
PSURs/ PBRERs or PADERs/PAERs
US FDA
As per standard US requirements every 3 months for two years and then yearly forever. As per ICH (or EU) timing, then the 3 month and annual reports.
IVD Class III
PSURs/ PBRERs or PADERs/PAERs
US FDA
As per standard US requirements every 3 months for two years and then yearly forever. As per ICH (or EU) timing, then the 3 month and annual reports
Get your necessary templates and procedures developed Plan and perform continuous Signal detection Led by safety physicians, resources are pooled globally to match speed and cost of these reports We use proprietary Authoring tools to ensure consistency and efficiency In addition, our teams can also perform Evaluation of the risk-benefit ratio to update in these reports Cross-functional teams with deep experience in Safety areas| EUROPE / EU MDR | |||
|---|---|---|---|
| Class I | PMSR | As Requested | As per Need |
| Class IIa | PSUR | NB Reviewed for Conformity | Every 2 years |
| Class IIb (Non-Implantable) | PSUR | NB Reviewed for Conformity | Annually |
| Class IIb (Implantable) | PSUR | EUDAMAD/ NB Reviewed for Conformity | Annually |
| Class III (Implantable) | PSUR | EUDAMAD/ NB Reviewed for Conformity | Annually |
| IVD Class A,B | PMSR | As Requested | As per Need |
| IVD C | PSUR | NB Reviewed for Conformity | Annually |
| IVD D | PSUR | EUDAMAD/ NB Reviewed for Conformity | Annually |
| CANADA | |||
|---|---|---|---|
| Class I | Summary Report | Not Required | Not Required |
| Class II | Summary Report | Health Canada | Every 2 years |
| Class III | Summary Report | Health Canada | Annually |
| Class IV | Summary Report | Health Canada | Annually |
| IVD Class I | Summary Report | Not Required | Not Required |
| IVD Class II | Summary Report | Health Canada | Every 2 years |
| IVD Class III | Summary Report | Health Canada | Annually |
| IVD Class IV | Summary Report | Health Canada | Annually |
| USA | |||
|---|---|---|---|
| Class I | PSURs/ PBRERs or PADERs/PAERs | Not Required | Not Required |
| Class II | PSURs/ PBRERs or PADERs/PAERs | US FDA | As per standard US requirements every 3 months for two years and then yearly forever. As per ICH (or EU) timing, then the 3 month and annual reports. |
| Class III | PSURs/ PBRERs or PADERs/PAERs | US FDA | As per standard US requirements every 3 months for two years and then yearly forever. As per ICH (or EU) timing, then the 3 month and annual reports |
| IVD Class I | PSURs/ PBRERs or PADERs/PAERs | Not Required | Not Required |
| IVD Class II | PSURs/ PBRERs or PADERs/PAERs | US FDA | As per standard US requirements every 3 months for two years and then yearly forever. As per ICH (or EU) timing, then the 3 month and annual reports. |
| IVD Class III | PSURs/ PBRERs or PADERs/PAERs | US FDA | As per standard US requirements every 3 months for two years and then yearly forever. As per ICH (or EU) timing, then the 3 month and annual reports |
The First Step
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