In April this year, Medsafe released the new draft guidelines for pharmacovigilance (PV) in New Zealand. Interested parties were invited to provide comment and Medsafe provided feedback on these on their website.
Part 8 of the Guideline of Therapeutic Products in New Zealand Edition 2 has now been released and is dated August 2015 for effect 1 January 2016. The new edition constitutes a major revision to provide a fuller, more detailed description of the requirements and includes additional sections on signal management, significant safety issues, safety monitoring documents and safety communications. It is important to note that requirements apply to medicines, vitamins, biologicals, OTC or other medicines providing they are approved medicines.
Some of the requirements, effective January 1 2016, include:
Roles and Responsibilities
- There is a recommendation that sponsors nominate a contact person and that this person needs to reside in NZ or be available during NZ business hours. Their contact details need to be provided to Medsafe.
- Access to a medically qualified person should be available when necessary.
- Sub contracts with 3rd party pharmacovigilance providers should be managed through detailed sub-contracting arrangements with sufficient detail to ensure responsibilities are understood and agreed. The sponsor however retains full responsibility to ensure an effective PV system.
- Emergency plans are expected to be in place to deal with critical incidents.
- Failure to meet sponsor responsibilities may result in action being taken under the Act.
- Definitions are clearly explained and are in line with ICH E2A and ICH E2D guidelines.
- Sponsors must report all serious spontaneous reports occurring in NZ where they meet the minimum criteria, irrespective of if the event was expected.
- Valid cases are considered for
- Approved medicines
- Approved medicines in a blinded study
- From solicited sources where assessment of causality indicated a positive correlation.
- While non- serious reports are not required, they should be available on request by Medsafe.
- Sponsors should establish a pharmacovigilance system to ensure sufficient information is collected for the evaluation of reports.
- Follow up should be attempted to establish minimum criteria and if reported from a consumer followed up with their health care provider, with consent.
- Where consumer consent is denied this should be documented.
- Valid Individual Case Safety Reports should be reported to the Centre for Adverse Reactions Monitoring (CARM) within 15 calendar days from Day Zero (manufacturer’s receipt date).
- Guidance is provided on a range of special situations such as; consumer reports, immunisation, lack of efficacy, off label use, clinical trials and medicines supplied under section 25 or 29.
- Scientific & medical literature should be reviewed not less than every three months to identify cases originating from NZ.
- Medsafe encourages sponsors to put in place a signal management process for each medicine. EU EMA, Module IX – Signal Management is recommended.
Significant Safety Issues
- Guidance is provided on what may constitute a significant safety issue and, in line with the TGA, these must be reported within 72 hours of awareness by the sponsor. Reporting is to the Clinical Risk branch not
Submission of safety monitoring documents
- Requirements for the submission of PBRERs in accordance with ICH E2C (2) are described, including where routine submissions are required.
- Medsafe do not require routine Risk Management Plans however these may be required during the evaluation process. The EU format is acceptable.
- EU Guidelines on GPV Module XV – Safety Communication provides guidance to determine best practice and DHCP communication should follow the EU template. A hyperlink is provided by Medsafe.
- The guidelines also list a variety of media that sponsors may choose in order to communicate risk minimisation and safety. They also recommend that health care providers and consumers be involved in the development and effectiveness testing of the materials to ensure messages are clearly understood.
- The guidelines also indicate the preference for safety related materials to be made available to Medsafe for review prior to distribution.
The Commercial Eyes professional and experienced Medical Services team can help with all your pharmacovigilance needs. Call us on +61 3 9251 0777 to arrange a meeting.
This article was written by Deidre Voss, Director, Medical Services.
Disclaimer: This is a summary of the Medsafe regulatory requirements Part 8 of the Guideline of Therapeutic Products in New Zealand Edition 2 by the author. The Guidelines should always be consulted and can be found on the Medsafe website: http://www.medsafe.govt.nz