Asia-Pacific Roundup: Malaysian device authority posts code of ethics and conduct
Posted 09 August 2022 By Nick Paul Taylor
Malaysia’s Medical Device Authority (MDA) has released a code of ethics and conduct that describes its approach to subjects such as conflicts of interest, confidentiality and the receipt of gifts.
Asia-Pacific Roundup: TGA focuses on continuous improvement in latest business plan
Posted 02 August 2022 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) has adopted four strategic objectives as part of its business plan for its 2022-23 financial year. The document sets TGA’s product regulation, stakeholder engagement and compliance and i...
Asia-Pacific Roundup: Malaysia’s NPRA details pilot project for track and trace system
Posted 26 July 2022 By Nick Paul Taylor
According to NPRA, the system is designed to ensure the supply chain only contains products registered with the Ministry of Health; ensure the availability of supplies and improve distribution efficiency; terminate existing security labe...
Asia-Pacific Roundup: TGA posts 2022-2023 priorities for import, advertising, supply compliance
Posted 19 July 2022 By Nick Paul Taylor
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...
Asia-Pacific Roundup: TGA updates uniform recall procedure
Posted 05 July 2022 By Nick Paul Taylor
Two key changes highlight the updated version 2.3 of the uniform recall procedure from Australia’s Therapeutic Goods Administration (TGA) – the removal of a section on crisis management guidelines and the addition of details on what the ...
Asia-Pacific Roundup: TGA adds chapters on SaMD, personalized devices to clinical evidence guidelines
Posted 28 June 2022 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) has updated its clinical evidence guidelines for medical devices, adding new chapters on software as a medical device (SaMD) and personalized medical devices (PMDs), prompted by regulato...
Asia-Pacific Roundup: India proposes QR codes on key medicines within the year
Posted 21 June 2022 By Nick Paul Taylor
Proposals to include a barcode on drug packaging date back to 2015 when the Indian government released a draft proposal for consultation. The proposal was never finalized because many “pharmaceutical companies showed their inability to i...
Asia-Pacific Roundup: Philippine FDA consults on accelerated registration of WHO-prequalified products
Posted 07 June 2022 By Nick Paul Taylor
FDA’s draft implementing guidelines apply to all FDA-licensed drug manufacturers, traders and distributors that have WHO-prequalified pharmaceutical products and vaccines and are seeking registration and post-approval changes.
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Sponsored Webcast: A Regulatory and Strategic Framework for Facilitating Pediatric Drug Development
Thursday, 22 September 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | Nonmember: $0
During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development.