Some of the Asia-Pacific countries invited to take part in the survey include Japan, South Korea, India and Australia, as there is high expenditure on health in these countries.
Led by principal investigator Professor Jo Barnes, deputy head at the School of Pharmacy, Faculty of Medical and Health Sciences at New Zealand’s University of Auckland, the survey is targeted at industry representative organizations, regulatory bodies and private pharmacovigilance consultants or service providers in selected developed economies.
Through a combination of open-ended and tick box-type questions, the survey is designed to gather perspectives from the dietary supplements and natural health products industry stakeholders and medicines regulators on pharmacovigilance approaches for these products.
For example, the survey will assess current pharmacovigilance activities and practices, views on regulations and barriers to meeting safety monitoring requirements and the potential for better alignment of systems internationally.
It will also explore opinions on safety monitoring methods beyond standard adverse event reporting that the industry could take part in.
The online survey, which is answered anonymously, is expected to take about 10 to 15 minutes to complete.
The aims
One of the aims is to find out how industry organizations and regulators across different regions navigate pharmacovigilance and best practices for meeting the requirements.
“The survey is designed to obtain a clearer picture of how current safety monitoring systems and requirements for dietary supplements and natural health products are viewed by manufacturers and regulators of these products,” said Professor Barnes. “We are particularly interested in learning from the dietary supplements and natural health products industry stakeholders about the challenges and opportunities in this area, and what resources and support the industry needs to help strengthen the safety monitoring for their products.”
Industry organizations can also invite their member companies to take part in the survey.
The survey also aims to find out the existing resources that the industry could refer to to meet pharmacovigilance requirements.
Doing so would be especially useful for the smaller players who might be less familiar with pharmacovigilance requirements and have less access to such resources, Professor Barnes told NutraIngredients.
“We want to find out how the industry handles pharmacovigilance regulatory requirements and whether there are particular resources or support that it needs to help it meet these regulatory requirements in the best way,” she said. “This piece of work is exploring these questions with dietary supplement / natural health products industry organisations and associations, and with regulators and pharmacovigilance professionals working in this area.”
Once the data is collected and analyzed, the plan is to submit the findings in an open-access journal, as well as communicated as conference abstracts in the coming one to two years.
Why embark on the research?
The inspiration for the survey research came from a previous work undertaken by Professor Barnes’ PhD student, Xin Yi Lim, where she noticed how safety monitoring requirements vary across jurisdictions.
In some countries, the standards of pharmacovigilance requirements could be as stringent as those of pharmaceuticals, while other countries might have limited or minimal oversight.
“For example, some countries require the industry or the sponsors, depending on how they define them, to report serious suspected adverse reactions to the regulators within 15 days of learning about them. However, this may not be a requirement in other countries, or may not apply to all types of natural health products within the same jurisdiction or country,“ said Lim.
