Asia-Pacific Roundup: TGA queries on big fee increases for upcoming financial year
Australia’s Therapeutic Goods Administration (TGA) has proposed double-digit increases to its annual charges to cover inflation and recoup investment in its digital transformation and move to purpose-built facilities.In a public consultation, TGA has outlined plans to apply a 5.2% indexation factor to fees and charges to cover most of its rising costs — inflation in Australia is 7% — while still incentivizing the agency to find savings and efficiencies. However, the 5.2% increase is not the only change. TGA’s government funding for some activities requires it to further increase fees to recoup the investment over the next five years.
Specifically, the government provided AU$23.3 million ($16.1 million) to complete TGA’s digital and business transformation and enable full implementation of the unique device identifier system and is paying the regulator’s landlord AU$4.85 million annually for 15 years to cover the fit out of its laboratory.
Industry will ultimately pay for the work. After factoring in cost recovery and lease charge back, TGA has calculated that annual charges for medicines and medical devices will increase by 11.56% and 12.33%, respectively. The increase for other annual charges, such as manufacturing licenses, is 11.1%.
TGA’s plan proved controversial when it met with industry groups last year, with attendees stating that the AU$23.7 million investment in digital and business systems “was drawn from the TGA Special Account cash reserve paid by industry in the past” and chiding the regulator for the lack of discussion of the relocation costs.
“There was also significant opposition to an increase in charges to cover a loan made to the Department to support the move of the TGA laboratory to the Fairbairn site. Industry emphasized that this impact on industry charges had not been raised with them prior to the Department’s decision to move to the new site,” TGA wrote.
TGA now is seeking broader feedback from industry. The consultation, which will close on 20 March, will enable TGA to gather input before it seeks approval for the fees and charges for the upcoming financial year. An amended regulation is scheduled for submission for consideration by the Federal Executive Council in May or June to “allow sufficient notice to affected businesses about changes to fees and charges effective from 1 July 2023.”
TGA Notice
Boehringer overturns India’s request for local clinical trial, clearing path for psoriasis drug
Boehringer Ingelheim has succeeded in persuading Indian officials to grant a local clinical trial waiver for spesolimab in generalized pustular psoriasis (GPP) at the second time of asking. The Dermatology and Allergy expert committee accepted the request after hearing Boehringer’s plan for a postmarketing trial.
In October, Boehringer presented a proposal for allowing the import and marketing of spesolimab in the absence of data from a local clinical trial. The experts rejected the request and recommended the company run a local clinical trial to prove the safety and efficacy of spesolimab in Indian GPP patients. The rejection reflected the lack of Indian patients in the Phase 2 trial and the belief that the current safety data was not adequate for a waiver.
Four months later, Boehringer tried again and received the result it wanted, provided it meets certain conditions. At the meeting last week, the company set out plans to include Indian patients in a Phase 4 open-label clinical trial. The postmarketing study will assess “the effect of immunogenicity on pharmacokinetics, safety and efficacy on re-treatment of flares that occurs after the first flare incidence has been treated and resolved in GPP flare.”
The experts recommended allowing Boehringer to import and market spesolimab without running a local clinical trial, provided the Phase 4 clinical trial includes a “reasonable number of patients from India” and that patients are screened for tuberculosis via QuantiFERON-TB Gold test, with positive patients excluded from the study.
Boehringer has three months from the receipt of the import and marketing clearance to submit its Phase 4 protocol to the Indian authorities. The clearance will see India join the US, EU, Japan, China and Taiwan on the list of markets where spesolimab is available under the brand name Spevigo.
Meeting Recommendations
TGA grants provisional approval of Moderna’s bivalent COVID booster
TGA has awarded Moderna provisional approval for the omicron BA.4-5 update to its Spikevax vaccine against COVID-19. The provisional approval covers the use of the vaccine as a booster shot.
Moderna secured the regulatory green light on the strength of the results of an ongoing Phase 2/3 trial and real-world data generated in Canada, Europe, Japan and the US in recent months. The clinical trial found the adapted vaccine elicited a better neutralizing antibody response against omicron BA.4/BA.5 strain than the original, monovalent Spikevax vaccine, and a “good” response against several currently circulating and emerging variants, TGA said.
The overseas real-world use linked the omicron augmented booster to “clear reductions in hospitalization and death,” according to TGA. The agency also considered early safety findings from the US Centers for Disease Control and Prevention, which found the new vaccine has a similar safety profile to the original Spikevax booster.
Spikevax is the second bivalent BA.4-5 vaccine to receive provisional approval in Australia; Pfizer received provisional approval last month. The next step is for the Australian Technical Advisory Group on Immunisation to advise the government on the potential inclusion of Moderna’s new booster shot in the national vaccination campaign.
TGA Notice
New Zealand adopts warning for ocular decongestants after discussing pediatric risks
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has adopted a warning for ocular decongestants after discussing the risks posed to children in a public consultation.
In 2021, a Medsafe committee noted that the packaging for naphazoline lacked a lower age limit for use. Because the medicine is available from pharmacies, it could be used inappropriately in children under 12 years old without further investigation or the input of a healthcare professional. Medsafe went on to expand the review to cover all ocular decongestants used for eye redness or minor eye irritation.
After running a public consultation last year, which received 10 valid submissions, Medsafe has refined and finalized its plans. Most respondents agreed that the New Zealand Label Statements Database (LSD) should include a warning statement for ocular decongestants with an age restriction for use. The feedback also included a suggestion to apply a separate age restriction to each ocular decongestant.
Medsafe responded by finalizing plans to add a warning statement to the LSD, with separate age restrictions for use for naphazoline and tetrahydrozoline. The limits for naphazoline and tetrahydrozoline are 12 years and six years, respectively, consistent with international labeling. Medsafe will update the LSD on 1 August and require products to carry the new warning statement from 1 February 2025.
Medsafe Notice
Other news:
Pakistan has proposed prioritizing the supply of drugs and medical devices to armed forces in wars and other emergencies. DRAP Notice
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