Asia-Pacific Roundup: TGA seeks feedback on plans to adopt 19 international scientific guidelines

Australia’s Therapeutic Goods Administration (TGA) has started a consultation into whether it should adopt 19 international scientific guidelines.

TGA currently uses around 370 international scientific guidelines to inform regulation in Australia. The adoption of documents created overseas forms parts of the regulator’s work to align its approaches to those of its international counterparts where possible.

“While international scientific guidelines that are adopted in Australia are generally not mandated by legislation, they provide guidance to sponsors to assist them to meet the legislative requirements,” TGA said. “Any deviation from a guideline relevant to an application to register or vary the registration of a medicine must be justified.”

TGA shared details of 19 international scientific guidelines it is considering adopting, most of which were created by the European Medicines Agency (EMA). The US Food and Drug Administration (FDA), International Council for Harmonisation (ICH) and World Health Organization (WHO) produced the other guidelines.

EMA produced the remaining documents under review at TGA. The guidelines include a pair of texts on good pharmacovigilance practices that took effect in Europe in 2017 and documents on controlling impurities and developing anticancer drugs that EMA adopted in 2022 and 2023. TGA is also weighing up whether to adopt more specific texts, such as bioequivalence documents for aliskiren and apixaban.

EMA guidelines include a pair of texts on good pharmacovigilance practices that took effect in Europe in 2017 and documents on controlling impurities and developing anticancer drugs that EMA adopted in 2022 and 2023. TGA is also weighing up whether to adopt more specific texts, such as bioequivalence documents for aliskiren and apixaban.

The FDA document up for adoption covers data standards for drug and biological product submissions containing real-world data published in late 2023. The guidance sets out the challenges of applying currently supported standards to data derived from real-world sources, such as the variety of sources and their inconsistent formats, and outlines how to manage those issues.

TGA also is considering adopting a WHO guideline on the nonclinical evaluation of vaccines from 2005 as well as one on adjuvants and adjuvanted vaccines from 2014.

The ICH documents under consideration are more recent. TGA is seeking feedback on whether to adopt ICH texts on products derived from cell lines of human or animal origin, gene therapies, drug interaction studies and bioequivalence for immediate-release solid oral dosage forms. ICH adopted the documents in 2023 and 2024.

TGA is accepting feedback until 16 January.

TGA Consultation

Researchers analyzes whether Ministry of Health follows PMDA approval recommendations

Researchers have analyzed the responses to the more than 2,000 approval recommendations Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) issued from 2002 to 2022.

New drug applications that pass PMDA review transfer to the Ministry of Health, Labour and Welfare (MHLW). MHLW’s Pharmaceutical Affairs and Food Sanitation Councils (PAFSC) consider the recommendations, and the Ministry grants drug approvals based on PMDA’s opinions. The Ministry can go against a positive review.

Writing in the journal Clinical Pharmacology & Therapeutics, researchers at Niigata University Medical and Dental Hospital said, “little is known regarding the relationship between the PMDA review and the MHLW decision.”

The researchers found that 98.3% of the more than 2,000 positive PMDA reviews were approved by MHLW after the initial deliberation of the PAFSC. While 36 applications were not approved at the initial deliberation, 29 of those products were ultimately authorized. Approvals were typically issued after a revision of the application, although data reanalysis was needed once and five products required additional clinical trials.

For drugs that were not approved after an initial deliberation, the researchers noted that “most of the concerns raised at the MHLW-PAFSC are made by stakeholders other than scientific members with relevant expertise.” Such arguments do not happen at the PMDA Expert Discussion because those stakeholders are not part of the process.

“In this context, enhancing the participants and transparency of the PMDA Expert Discussion whose roles are similar to the FDA Advisory Committee and the EMA CHMP, of which only a few summary sentences are presented in the review reports, with the abolishment of the repetitive process by the MHLW-PAFSC may be helpful to boost scientific discussion and achieve a more rapid drug approval through more simple and reasonable review process,” the researchers said.

The proposal to integrate the MHLW-PAFSC deliberations into the PMDA review to improve access to new drugs comes as Japan works to accelerate approvals. Officials want to close the gap between the first global approval and authorization in Japan, for example by waiving the requirement for domestic Phase I trials of overseas drugs before Japanese people participate in international Phase III studies.

PMDA Paper

Medsafe to review request to expand access to HIV prophylaxis drugs in New Zealand

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has scheduled a meeting to discuss a request to expand access to HIV prophylaxis medication.

Burnett Foundation Aotearoa, a HIV-focused charity, has asked Medsafe to reclassify tenofovir disoproxil and emtricitabine to allow pharmacists to supply the medicines for HIV pre-exposure prophylaxis (PrEP). Currently, people need to get a prescription from a doctor to access the drugs. The charity said the current pathways have not been able to achieve high levels of equitable access.

Reclassifying the medications “will aid PrEP initiation for people who are unable/uncomfortable to get GP-initiated supply,” the charity said. Māori and Pacific peoples have lower rates of PrEP initiation and retention, as do young men who have sex with men and people living outside of the main urban areas.

Medsafe will consider the reclassification request at a meeting in February. The meeting will also discuss other requests, including an application by GSK New Zealand that would enable a wider range of people to administer its shingles vaccine Shingrix.

Meeting Agenda

TGA approves product substitutions to mitigate HRT patch shortage

TGA has authorized pharmacists to substitute a prescribed estradiol transdermal patch with another hormone replacement therapy (HRT) to mitigate shortages of Sandoz and Juno products.

Bayer stopped supplying its Climara HRT patches in Australia at the end of last year. TGA said the discontinuation contributed to supply constraints of alternative products. Last week, Australia adopted a Serious Scarcity Substitution Instrument to allow pharmacists to provide another HRT product when the prescribed patch is not available.

Pharmacists can either provide an alternative brand of estradiol transdermal patch of the same strength or two packs of half the prescribed strength to make the same equivalent daily dose. TGA expects the normal supply of some products to resume next month but forecasts the disruption to the availability of another brand will continue until the end of 2025.

TGA Notice

Other news:

The Philippine Food and Drug Administration (FDA) has told companies to send documents and samples for approved batch notification applications to show they are meeting the regulatory requirements by 27 November. FDA may cancel batch notifications and suspend market distribution upon inspection if a company fails to comply with the request. FDA Notice

TGA has told healthcare professionals not to use Sanofi-Aventis Healthcare’s oral antihistamine Phenergan in children under six years of age. The alert, which applies to generic brands of promethazine hydrochloride, follows assessments of the risks of psychiatric and central nervous system side effects in young children. TGA Notice

Asia-Pacific Roundup: TGA seeks feedback on plans to adopt 19 international scientific guidelines

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