Asia-Pacific Roundup: New Zealand’s new database aims to improve ADR turnaround time

Authorities in New Zealand are transitioning the collection and storage of adverse reaction (ADR) reports to a new database to improve efficiency and shorten processing time.

The original system used by New Zealand’s Centre for Adverse Reactions Monitoring (CARM) and Medicines and Medical Devices Safety Authority (Medsafe) was established by the University of Otago in 1965.

“A database containing details of all ADR reports received in New Zealand is critical to the work that CARM and Medsafe do. An aging database and advancing technology resulted in CARM and Medsafe working together to develop a new state-of-the-art digital solution,” according to a joint letter from the bodies.

CARM and Medsafe began using an early version of the system late last year to process ADRs for vaccines against COVID-19 and Mpox. They have now completed work on the new system.

“CARM and Medsafe are implementing changes to the processing of ADRs. The database and initial processing will be centered in Medsafe, and the CARM experts will focus on the valuable role of medical assessment of non-routine reports. CARM will continue to respond to those reports they review and advise if an alert has been entered in the national Medical Warning System. Importantly, the reporting of adverse reactions to medicines remains ‘no fault’,” according to the letter.

The new system should improve turnaround times for ADR processing and free staff at both organizations to “focus more time on the analysis of reports, contributing to improved signal detection and overall medicine safety monitoring,” the letter states.

Work is underway to preserve the information contained in the old CARM database. CARM and Medsafe have routinely shared ADR details since November 2012 to facilitate their pharmacovigilance activities. The partners plan to migrate all data from before November 2012 to the new system, subject to industry feedback and “supporting advice” from New Zealand’s Privacy Commissioner.

CARM and Medsafe are collecting feedback and responding to questions until 29 September.

Joint Letter

Australia ends requirement for printed product information for certain injectables

Manufacturers of injectable products administered by healthcare professionals no longer need to include printed product information in their Australian packaging.

The changes came into effect on 1 September. Healthcare professionals can continue to access product information on the website of Australia’s Therapeutic Goods Administration (TGA), and injectables that are administered by the patient or a carer will continue to ship with printed product information in the package.

The new policy is based on feedback TGA received last year. The consultation received a mix of responses, with some people stating that including a hard copy may be valuable in the first two years a product is on the market and others voicing support for the inclusion of a shorter document that could ensure safety and minimize waste.

Yet, TGA ultimately decided the benefits of including some form of hard copy are outweighed by several downsides to providing printed information. The administration concluded that printed materials may be out of date and, with documents now typically 10 to 35 pages long, they have an environmental impact. Including a hard copy can increase the package size.

The pros and cons led TGA to decide to free pharma companies from the need to include a hard copy of the product information in the packages of injectables administered by healthcare professionals. Some products that are already on the market will continue to have printed package inserts.

TGA Notice

TGA increases regulatory oversight of sports supplements in medicinal dosage forms

Australia is set to start regulating sports supplements that make claims relating to performance in sport, exercise or recreational activity and are provided in a medicinal dosage form as therapeutic goods.

The change, which will take effect from 30 November, means sports supplements that are sold as tablets, capsules or pills and make performance claims must be included in the Australian Register of Therapeutic Goods (ARTG). Affected products will also need to meet the applicable requirements for manufacturing, formulation, labeling and evidence. The rules on advertising the products will change too.

The changes were made in response to a law passed three years ago which clarified that TGA will regulate a sports supplement as a therapeutic good if it is “used, advertised, or presented for supply” for therapeutic use or “in a way that is likely to be taken to be for therapeutic use.” The law lists gaining muscle, increasing mental focus and losing weight as examples of therapeutic uses.

The changes are intended to address the safety risks of certain sports supplements. Sports products that contain certain ingredients have needed to comply with the therapeutic goods rules since 2020. Last week, TGA fined EmpireLabz Australia AU$ 115,000 ($74,000) for the alleged unlawful advertising and supply of sport supplement products not included in the ARTG.

TGA Notice, More

Australia closes postmarket review of facemasks as public health emergency ends

TGA has closed the postmarket review of facemasks that it initiated at the start of the pandemic. The administration took the step after the World Health Organization declared COVID-19 is no longer a public health emergency of international concern.

Early in the COVID-19 crisis, TGA began reviewing all facemask entries in the ARTG to ensure their quality, safety and performance. The regulator managed devices that were noncompliant as Product Defect Alerts rather than removing them from use, reflecting concerns about the availability of facemasks during the pandemic.

Noncompliant facemasks now will be subject to recall actions consistent with the administration’s standard, non-pandemic approach.

TGA Notice

Other news:

TGA has warned the industry about scam callers. The administration has learned that “a small number of people have received calls from scammers impersonating the TGA.” Such scammers typically try to trick people into providing personal information or money. TGA said impersonating fraudsters are calling from the number 02 6289 4124. Legitimate TGA calls display as a private number, and the administration will not ask for personal information or payment over the phone. TGA Notice

TGA is seeking feedback on a proposal to make effervescent paracetamol preparations of 16 tablets or less packed in a container with a child-resistant closure available for general sale. The administration moved to increase regulatory controls on paracetamol earlier this year but the applicant argues effervescent dosage forms “impede or discourage” intentional overdose. TGA Consultation

Asia-Pacific Roundup: New Zealand’s new database aims to improve ADR turnaround time

Related topics

Recommended content

Welcome to the new RAPS Digital Experience