The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has updated its guideline on pharmacovigilance after receiving support for changes it proposed late last year.
Medsafe ran a consultation in November and December to gather feedback on plans to change its advice on collecting and reporting suspected adverse reactions and what it treats as a significant safety issue. The plans included the introduction of the “other safety issue” category. Medsafe wanted to know if it had clearly explained the safety categories and the sponsor’s role in collecting adverse reaction reports.
The agency received 15 submissions to the consultation, all of which were sent by sponsors or other organizations involved in pharmacovigilance activities.
“Most respondents agreed with the proposed updates,” according to Medsafe. “Several respondents suggested changes to wording, layout and/or formatting to improve clarity. There were also requests to add examples or further detail to some sections to improve understanding and interpretation. Where appropriate, we have incorporated these suggestions into the revised guideline.”…
