Asia-Pacific Roundup: Philippine FDA seeks feedback on expedited evaluation of medical devices
The Philippine Food and Drug Administration (FDA) is seeking feedback on the expedited review of medical devices that already have been authorized by another national regulatory authority (NRA) in the Association of Southeast Asian Nations (ASEAN).In line with World Health Organization advice about the benefits of relying on other regulatory agencies, FDA has set out draft guidelines on the abridged processing of fillings for registration and notification of certain medical devices. The expedited pathway will apply to products approved by the NRA of an ASEAN member country under the requirements of the ASEAN Medical Device Directive Common Submission Dossier Template (AMDD-CSDT).
“The applicant shall submit complete legal and applicable technical requirements when applying for registration/notification of medical devices. The technical requirements to be submitted shall be the same as those submitted to the reference NRA of the ASEAN member country where the Certificate of Product Registration (CPR) was issued,” the guidelines state.
FDA is proposing that applicants attest that the CSDT technical documentation is identical to that filed with the other ASEAN NRA and acknowledge that the agency may automatically suspend the product if there is an unauthorized change in its details and documentation. Unauthorized changes also may trigger voluntary recalls. FDA is indemnified against third-party claims relating to unauthorized changes under the draft guidenlines.
Submissions for expedited review will undergo a pre-assessment process, during which FDA will check the completeness of the legal and technical requirements. FDA will only issue an order of payment after determining that an application is complete. The agency will verify the submitted CPR from the reference NRA of the ASEAN member country.
CPRs issued based on an abridged approval in countries outside the ASEAN are ineligible, and the pathway is only open to Class B, C and D medical devices. FDA is reserving the right to refuse expedited review if it receives a negative report about the medical device from other countries, ASEAN NRAs have conflicting views about a product or because it otherwise thinks a full evaluation is needed.
FDA is accepting feedback on the proposal until 25 April.
Draft Guidelines
TGA fines COVID vaccine developer for alleged unlawful advertising
Australia’s Therapeutic Goods Administration (TGA) has fined Vaxine AU$13,320 ($9,970) for allegedly unlawful advertising an unapproved COVID-19 vaccine. The allegation centers on content published on Facebook and YouTube.
Vaxine has raised AU$1 million through a crowdfunding campaign to push for approval of its recombinant protein COVID-19 vaccine candidate, Advax-CpG55.2, in its home market of Australia. TGA granted Vaxine provisional determination late last year, clearing it to apply for provisional registration in the Australian Register of Therapeutic Goods.
TGA issued Vaxine with an infringement notice because the company “did not adequately address a range of concerns with the social media advertisement” that the agency raised with the company’s director by phone and in writing.
TGA said that, while factual information about clinical trials is published on Australian New Zealand Clinical Trials Registry and related overseas registries, sponsors cannot advertise unapproved goods such as candidates undergoing clinical trials because they are yet to complete assessment by the agency.
“Publicly available information about any clinical trial must be factual and balanced and must not promote the use or supply of the therapeutic goods that are the subject of the trial. Advertisers of therapeutic goods are reminded that the term 'advertise' in relation to therapeutic goods refers to any statement, pictorial representation or design that is intended to promote the use or supply of the goods in the eyes of a reasonable consumer,” TGA wrote.
TGA Notice
China’s NMPA posts guidance on self-inspection of device quality systems
China’s National Medical Products Administration (NMPA) has updated its guidance on the annual self-inspection of medical device quality management systems as part of a raft of changes that will take effect on 1 May.
The updated guideline is one of three new or updated documents that NMPA will implement in a little over one month. The other documents cover prohibited medical device manufacturing and compiling quality agreements. NMPA framed the documents as a way to strengthen the supervision of medical device production and ensure the safety and effectiveness of products sold in China.
The release of the documents comes one year after China’s State Council released details of a significant revision to the medical device regulatory framework. The revised framework clarified that medical device marketing authorization holders are responsible for the safety of and effectiveness of their products throughout the life cycle.
NMPA Notice (Chinese)
India approves Novavax’s COVID vaccine for use in adolescents
The Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) to Novavax’s COVID-19 vaccine in adolescents aged 12 to 18 years. Novavax said the DCGI decision is the first authorization of its protein-based vaccine in the adolescent population.
Working with the Serum Institute of India, Novavax secured EUA for its NVX-CoV2373 vaccine in India in adults late last year. The extension of the label to cover adolescents is underpinned by a phase 2/3 clinical trial that studied the vaccine in 460 Indian individuals aged 12 to 18 years. According to Novavax, the trial showed NVX-CoV2373 “was well-tolerated with a reassuring safety profile.”
The EUA filing also referenced data from a US clinical trial that delivered topline data earlier this year. That study, which took place before the rapid rise of the Omicron variant, linked the vaccine to 82% clinical efficacy against the Delta variant.
Press Release
China’s NMPA prepares for WHO assessment of vaccine regulatory capacity
China’s NMPA has held a meeting in preparation for a national regulatory authority (NRA) assessment of vaccines by the World Health Organization (WHO). The assessment will cover China’s vaccine regulatory capacity and level.
Vaccine regulation has been a source of headaches for China in recent years, with scandals such as the discovery that Changsheng Biotechnology had fabricated production and inspection records rocking the country. Since then, Chinese authorities have sought to improve oversight, jailing some ex-regulatory officials and taking steps to enhance quality management and traceability.
The upcoming WHO assessment in June represents a test of China’s vaccine regulatory capacity and level. NMPA wants to ensure China passess the test and lays the groundwork for future enhancements to the system.
“In terms of current problems and challenges, it is important to carefully analyze causes and accelerate rectification and improvement. Efforts should be made not only to pass the assessment, but also to lay a solid foundation for the modernization of China's vaccine regulatory system and capacity in the long run,” NMPA wrote.
NMPA Notice
Other news:
The Philippine FDA has issued warnings against the purchase of a clutch of counterfeit products. One of the warnings covers counterfeit versions of Alaxan, a combination of ibuprofen and paracetamol. The other warning presents details of counterfeit versions of Dolfenal, Solmux and Tuseran Forte. The FDA warnings are aimed at healthcare professionals, consumers and retailers of medicines. FDA Notice, More
