Asia-Pacific Roundup: TGA posts 2022-2023 priorities for import, advertising, supply compliance

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| 19 July 2022 | By Nick Paul Taylor 

Australia’s Therapeutic Goods Administration (TGA) has published its compliance priorities for imports, advertising and supply. The list of priorities, which is topped by actions against unapproved COVID-19 products, covers the agency’s 2022 to 2023 financial year.
 
The list includes seven compliance priorities. First up: to “deter and address the unlawful import, advertising and supply of unapproved therapeutic goods associated with COVID-19.” To do so, TGA will provide information to the community and therapeutic goods industry about how to comply with the regulatory requirements and target alleged unlawful activities, both on its own and in collaboration with other agencies.
 
The focus reflects a belief that “it is important that therapeutic goods associated with the prevention, diagnosis and treatment of COVID‑19 infections have been appropriately approved for supply.” While the crisis phase of the pandemic has passed, TGA continues to see unlawful supply as a problem, leading it to make the topic that shaped the two previous financial years a focus on the coming 12 months.
 
Other strategic priorities including medicinal cannabis, performance enhancing drugs, unlawful adverts aimed at vulnerable people and online sales of unapproved therapeutic goods. The focus on medicinal cannabis comes as Australia revises aspects of its regulatory framework. TGA wants to ensure compliance with the requirements by talking to the industry, using intelligence to identify noncompliance and targeting unlawful advertising.
 
The focus on gathering and using intelligence to identify noncompliance recurs in TGA’s discussion of its approach to performance enhancing therapeutic goods. TGA’s plan to disrupt the unlawful importation, manufacture, advertising and supply of performance enhancing drugs also includes the targeting of online platforms, a strategy that itself overlaps with the agency’s broader focus on e-commerce. The agency will work with online stores to remove unlawful adverts and take enforcement action if needed. 
 
TGA is particularly concerned about unlawful adverts, both online and in other media, that make claims about serious conditions without robust evidence and are aimed at especially vulnerable individuals. The concern reflects the recognition that consumers with limited treatment options may be susceptible to unlawful adverts.
 
TGA Notice
 
Malaysia’s NPRA updates variation guideline to align requirements with ASEAN
 
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated its variation guideline for pharmaceutical products, reflecting revisions to the Association of Southeast Asian Nations’ (ASEAN) position on the topic.
 
NPRA published the first version of the guideline in 2013. Since then, ASEAN has made two rounds of changes to its variation guideline for pharmaceutical products, first in 2019 and then in 2021. The ASEAN-related revisions affect the reclassification of two variation types, the addition of new variation types and changes to existing variation types.
 
Most of the changes relate to the addition of new variation types. The new types listed by NPRA in its summary of the revisions include addition of a primary packaging site for non-sterile drug product, change of drug substance submission option and update of the good manufacturing practice certificate.
 
NPRA made some other changes unrelated to the ASEAN update, including timeline revisions. NPRA will issue first correspondence or approval for single major variations within 60 working days. If variations, including a major variation, are grouped, NPRA will take up to 100 working days to issue first correspondence or approval.
 
NPRA Guideline
 
New Zealand seeks feedback on plan to ban ocular decongestants in children under 12
 
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is seeking feedback on plans to restrict use of ocular decongestants to people aged 12 years and up considering the risk of harm.
 
Last year, New Zealand’s Medicines Adverse Reaction Committee noted that one brand, the naphazoline therapy Clear Eyes, lacked a lower age limit for use. Because naphazoline should only be used in people aged 12 years and up, the committee recommended using that as the lower age limit for Clear Eyes. The process led the committee to recommend a broader review of the label statements database.
 
Currently, some, but not all, naphazoline-based eye drops carry an age limit of 12 years. The labels of eye drops based on tetrahydrozoline state they should not be used by children under six years. Under the new proposal, Medsafe will use 12 years as the minimum age limit for all ocular decongestants.
 
The proposal applies to naphazoline, tetrahydrozoline and phenylephrine, although no eye drops based on the latter ingredient are approved in New Zealand for the treatment of eye redness. The proposal does not apply to the use of phenylephrine in diagnostic procedures.
 
Medsafe’s consultation asks whether the respondent supports the proposed changes and whether there are other advisory statements that should be added to the label. The consultation closes on 22 August.
 
Medsafe Consultation
 
FDA moves to align guidelines on importing radiation devices into the Philippines
 
The Philippine Food and Drug Administration (FDA) is amending its guidelines on customs release for radiation devices to align the text with an order on the ASEAN harmonized technical requirements.
 
FDA published its guidelines on the issuance of clearance for customs release of radiation devices in 2017. The following year, the Philippine Department of Health released an administrative order on the issuance of medical device authorizations based on the ASEAN harmonized technical requirements. The latest FDA release is intended to align the two earlier documents.
 
In an update to its 2017 text, FDA has clarified that all medical radiation devices shall be classified in accordance with the agreed classification of the ASEAN Consultative Committee on Standards and Quality – Medical Device Product Working Group. The changes mean a certificate of medical device registration or notification (CMDR/CMDN) will be needed for radiation devices used in medical contexts.
 
The update is set to take effect 15 days after its publication in a newspaper but is subject to a transition period. Starting 1 April 2023, all marketing authorization holders need to apply for a CMDN. FDA will honor the existing clearance for customs release and license to operate while CMDN applications are ongoing.
 
FDA Guidelines
 
TGA extends shelf life of batches of Boehringer drug to mitigate 18-month shortage
 
TGA has extended the shelf life of certain batches of Boehringer Ingelheim’s Metalyse to mitigate the impact of a shortage that is forecast to last for 18 months.
 
Boehringer filed to extend the expiry date of four batches by one year to reduce waste and increase access to the medicine, which is used to dissolve blood clots immediately after a heart attack. TGA accepted the request on the grounds that it will have no effect on the safety or efficacy of the therapy.
 
With the shortage, which stems from increased global demand, expected to continue until around the end of next year, TGA is working with Boehringer and clinical experts to assess the likely impact of interruptions to the supply of Metalyse. TGA has also approved the supply of two equivalent products that are registered overseas to provide alternative supply sources.
 
TGA Notice
 
Other news:
 
China's National Medical Products Administration (NMPA) has approved a locally developed artificial heart. NMPA Notice

 

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