Asia-Pacific Roundup: TGA starts offering charge waivers and refunds to sponsors of reclassified medical devices

Australia’s Therapeutic Goods Administration (TGA) has begun accepting applications for annual charge waivers and refunds from medical device companies. The scheme is open to companies with devices that are being reclassified as a result of changes to the regulatory framework in the European Union.

Under Australian legislation passed in 2019, certain categories of medical devices are being reclassified so they align with the new EU framework. Affected sponsors can continue to supply devices under their existing Australian Register of Therapeutic Goods (ARTG) entries while waiting for the new classifications to be added to the register.

Some transitioning devices are also part of the Private Health Insurance (Medical Devices and Human Tissue Products) Rules, formerly known as the Prostheses List. Those sponsors need to have their new ARTG entries added to the list, which is only updated a few times a year.

The situation means sponsors may simultaneously have two ARTG entries for different classifications of the same medical device. Maintaining two ARTG entries simultaneously will impose financial burdens on sponsors. TGA has agreed to waive or refund the annual charge for the ARTG entry covering the previous classification to alleviate those financial burdens.

TGA began accepting applications for waivers and refunds on 1 July and recently published details of the eligibility criteria and submission process. The initiative is open to transitional medical devices that are included in the ARTG under two different classifications.

To facilitate applications, TGA has created an online form that allows sponsors to provide information on up to 10 eligible medical devices at once. The form asks questions about whether any non-transitioning devices are currently included under the ARTG entry and whether the transitioning ARTG entry is listed on the Private Health Insurance list to determine if the product is eligible for a refund or waiver.

TGA Notice

India continues to grapple with cough syrup testing demand as backlog grows at some sites

Efforts by India’s Central Drugs Standard Control Organization (CDSCO) to improve the management of cough syrup testing are yet to resolve the problem, with the backlog at the Mumbai lab rising again and a second site now also facing high demand.

Since 1 June, manufacturers of cough syrups have needed to send samples for testing at one of 14 sites to obtain a Certificate of Analysis before being allowed to export products. The scheme quickly ran into issues. By June 21, the Mumbai laboratory had 93 samples awaiting testing while six of the facilities had none. Only one other laboratory had more than seven samples under analysis.

The situation led CDSCO to ask manufacturers to stop sending samples to Mumbai and instead use one of the laboratories that had no other cough syrups under analysis. Now, less than two weeks later, the regulatory agency has put out a second notice.

As of 3 July, the Mumbai laboratory had more than 100 samples. The backlog of samples at the Indian Pharmacopoeia Commission’s facility in Ghaziabad now also exceeds 100. Ghaziabad had 24 samples under analysis as of 21 June.

CDSCO responded to the growth of the backlog in Mumbai and the emergence of problems at Ghaziabad by asking manufacturers to stop sending samples to either laboratory. The ban will remain in place until the sites have analyzed all their current samples and released the reports. Until then, CDSCO wants cough syrup producers to check its list of the backlog of samples and choose sites with low workloads.

CDSCO Notice

‘Unpredictable’ timeline leads Malaysia to allow expired CE marks for conformity assessments

Malaysia’s Medical Device Authority (MDA) has set out how it will mitigate the “unpredictable timeline and issues with regards to the transition” to the European Union’s Medical Device Regulation (MDR).

The Malaysian conformity assessment process recognizes EU CE mark certificates, allowing companies to use the materials to support the verification of their devices and registration for sale in the country. The certificates should be “valid during the new registration and re-registration submission” in principle, but issues around the MDR transition have led MDA to relax that principle.

To ensure the continued supply of medical devices, MDA is allowing manufacturers to use expired CE mark certificates as part of the Malaysian conformity assessment process, provided certain conditions are met.

Devices that are supported by expired certificates must: continue to comply with the EU medical device directives; not undergo significant changes to their design and intended purpose; and not present “an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health.”

MDA is asking manufacturers that want to use an expired CE mark certificate to provide “a formal letter from the national competent authority that has granted a derogation from the applicable conformity assessment procedure.” A notified body letter confirming receipt of a filing for conformity assessment, a quality management system audit report and a letter about a delayed certificate are also acceptable.

MDA Notice

TGA extends Ozempic shortage to end of 2023 despite ‘steady ongoing supply’ from Novo Nordisk

TGA and other stakeholders have relaxed the restrictions on the use of Novo Nordisk’s diabetes medicine Ozempic but extended its inclusion in the drug shortage database until the end of the year.

When TGA added the shortage to its database in April 2022, it expected increased demand to affect the supply of Ozempic until June 2022. One year after the originally targeted end date for the disruption to supply, TGA met with Novo Nordisk and organizations representing healthcare professionals and patient groups to discuss the current situation.

Availability is improving, according to TGA, and Novo Nordisk anticipates “steady ongoing supply.” Yet, in light of “ongoing significant demand,” TGA will keep the drug listed on its shortage database until at least the end of the year.

The shortage listing restricts the use of Ozempic. Previously, supply was limited to patients who were already taking the medicine for type 2 diabetes that was not sufficiently controlled with other medicines. Now, Ozempic is available to people who have not previously taken the medicine and who meet the other existing criteria for use. Off-label use to treat obesity will remain banned until the end of the year.

TGA Notice

Singapore’s HSA finds 190 liters of cough syrup in bust of suspected illegal codeine syndicate

Singapore’s Health Sciences Authority (HSA) has seized money and cough syrup from a suspected illegal codeine syndicate.

According to HSA, the joint operation with other agencies in Singapore seized more than S$680,000 ($500,000) in cash and 190 liters of cough syrup that the agency valued at S$150,000. HSA alleges that the syndicate sourced codeine from a clinic and processed it at a residential unit. The six people being investigated will face up to two years in prison if found to have traded unregistered health products.

“Collaborative efforts between the police and HSA have enabled us to successfully uncover and disrupt the illegal supply of cough syrups and other medicines,” Annie Tan, director of enforcement branch, HSA, said. “HSA will continue to step up on enforcement efforts and work with the relevant agencies on raid operations in targeted areas to crack down on the illegal supply of such medicines.”

HSA Notice

Asia-Pacific Roundup: TGA starts offering charge waivers and refunds to sponsors of reclassified medical devices

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