Asia-Pacific Roundup: TGA seeks feedback on international clinical trial, pharmacovigilance guidelines
Australia’s Therapeutic Goods Administration (TGA) is running a consultation into plans to adopt three international scientific guidelines.TGA, which has a policy of aligning with comparable international regulators whenever possible, has so far adopted around 370 overseas guidelines for use in Australia. The agency put forward another three international texts for consideration late last week, giving the industry until 30 June to share feedback on whether the documents should be adopted.
Two of the documents were developed by the European Medicines Agency (EMA). One of the EMA documents is a guideline on quality documentation for medicinal products when used with a medical device that came into effect in the European Union at the start of 2022.
The guideline describes the information applicants should include in the quality part of the marketing authorization dossier for a medicinal product when it is used with a medical device. The advice applies to medicinal products that form an integral product with a medical device, that are packed with a medical device or have product information that refers to a specific medical device that is obtained separately.
EMA said medicinal products are increasingly developed for use with medical devices, which range from prefilled syringes to sensors embedded in tablets. The rise of a wide range of devices that are used with medicinal products led to submissions that were “inconsistent and often incomplete,” EMA said. The EU agency created the guideline to advise applicants on the information to include in submissions.
The other EMA guideline under consideration by TGA covers pharmacovigilance systems. EMA brought the guideline into effect in 2012. The document provides quality objectives and guiding principles for pharmacovigilance systems and good practices.
Sections of the guideline cover overall pharmacovigilance responsibilities in the EU regulatory network and data protection in the EU. TGA’s request for feedback includes a note about aspects of the guideline that are specific to the EU.
“The sponsor should consider the EU guideline as recommendations for establishment and maintenance of their pharmacovigilance system,” TGA said. “Sponsor should refer to the current version of Pharmacovigilance responsibilities of medicines sponsors - Australian recommendations and requirements for the legal Australian requirements.”
TGA is also seeking feedback on plans to adopt an International Council for Harmonisation (ICH) guideline that came into effect in the EU in 2020. The document, an addendum to ICH E9, “presents a structured framework to strengthen the dialogue between disciplines involved in the formulation of clinical trial objectives, design, conduct, analysis and interpretation.”
TGA Notice
New head of Philippine FDA begins ‘thorough review’ of regulator’s core operations
The new director general of the Philippine Food and Drug Administration (FDA) has started “a thorough review of the agency’s core operations, including inspection, licensing and monitoring.”
Paolo Teston has taken over from Samuel Zacate, who took up the post in 2022. Addressing FDA staff for the first time, Teston said he assumes the “role with a clear and urgent mandate: to raise the standard of service at the FDA—not through promises or plans alone, but through action.” The focus is on restoring public trust in the agency.
FDA said the review launched by Teston will inform reforms that are “swift, strategic and anchored on concrete results.” Public details of how the new director general plans to change FDA are yet to emerge but the broad focus is on increasing trust and ensuring the safety of health products.
Teston, a lawyer by training, pledged to explore ways to improve job security, professional growth and working conditions across the agency. As an active member of the Department of Health’s executive committee, Teston also vowed to represent the agency’s interests at the highest levels of policy making and governance.
FDA Notice
TGA starts consultation into classification of Novo Nordisk and Pfizer growth treatments
TGA is seeking feedback on the classification of human growth hormone (HGH) products manufactured by Ascendis Pharma, Novo Nordisk, and Pfizer. The World Anti-Doping Agency lists the three molecules as prohibited substances because of their potential misuse in sports.
The three HGH products are functional analogs of somatropin, a synthetic version of HGH. Somapacitan, the active ingredient in Novo’s Sogroya, is listed in Schedule 4 but not Appendix D in the current Australian Poisons Standard. Schedule 4 covers prescription-only medicines. Appendix D lists Schedule 4 substances that have common therapeutic uses.
Somatrogon and lonapegsomatropin, the active ingredients in Pfizer’s Ngenla and Ascendis’ Skytrofa, respectively, do not have separate entries in the current Poisons Standard. Lonapegsomatropin is the only one of the three molecules without an entry in the Australian Register of Therapeutic Goods.
TGA is considering changing the Poisons Standard to ensure consistent interpretation of the scheduling of the molecules, which have similar functions, uses and risk profiles. The changes would create Schedule 4 and Appendix D entries for somatrogon and lonapegsomatropin. TGA is also proposing to create an Appendix D entry for somapacitan.
The consultation closes on 13 June.
TGA Consultation
WHO issues warning about falsified versions of AstraZeneca’s cancer therapy Imfinzi
The World Health Organization (WHO) has posted an alert about falsified copies of AstraZeneca’s cancer drug Imfinzi in Iran and Türkiye. The alert comes five months after WHO issued a notice about falsified Imfinzi in Armenia, Lebanon, and Türkiye.
WHO received reports in March that falsified Imfinzi products were found in Iran, a country in West Asia, and Türkiye. The products deliberately misrepresent their identity, composition and source, WHO said, and as such are falsified. AstraZeneca found multiple visual discrepancies in the products and told WHO the three batches are falsified.
Two of the batches have genuine lot numbers for products that can be distributed in India and Egypt. Discrepancies in the packaging artwork and text placement, including some missing text, show the two batches are falsified. The third batch has a lot number that is not recognized by AstraZeneca. WHO said any Imfinzi batches with that lot number are falsified.
The falsified products should be considered unsafe, WHO said. The health body is advising “increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these falsified products.” WHO is also recommending increased oversight of informal or unregulated markets.
WHO Alert
Other News:
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published details of updates on work to develop safety measures that predict and prevent adverse drug reactions. PMDA began developing manuals about specific reactions in 2005. The agency published updates to three of the texts in March. PMDA said it is working on updates to another six texts and trying to raise awareness. PMDA Report
TGA has shared advice for Australian patients who are prescribed unapproved therapeutic goods. The agency said it is “important to know that unapproved goods often haven’t undergone the same rigorous process for safety, quality and efficacy as products included” in the Australian Register of Therapeutic Goods. TGA listed questions patients should ask to make informed treatment decisions. TGA Notice
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated the package inserts for all products containing statins, rituximab or isotretinoin to add safety information. The statin insert now says that “in few cases, statins have been reported to induce de novo or aggravate pre-existing myasthenia gravis or ocular myasthenia.” Statins, Rituximab, Isotretinoin (all Malay)
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