Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Releases Advertising Breach ‘Stop Clock’ Policies as Legal Case Advances
Australia’s Therapeutic Goods Administration (TGA) has discussed when it will stop the clock in its handling of complaints about advertising. TGA updated its policy on the same day as it shared new details of its legal case against Peptide Clinics Australia.
The original TGA guide to the handling of advertising complaints published last year lacked details of when the agency would stop the clock on cases. TGA closed that gap in the document last week with the addition of a new section to the guide, which details the agency actions that will necessitate the application of a stop clock.
TGA will stop the clock when it requests further information from third parties, including advertisers, complainants, external experts and government bodies. The agency may request such information when it needs to verify a complaint, obtain a copy of an advert or access data to substantiate claims made in promotional materials.
Officials also plan to stop the clock when pursuing legal proceedings such as court injunctions.
“It will also be applied where a matter is the subject of court proceedings. The clock restarts when the TGA receives the requested information, or when the court proceedings are finalized,” TGA wrote in an update to its guide to the handling of advertising complaints.
TGA shared details of the effect of legal cases on its timekeeping on the same day as it provided an update on its action against Peptide Clinics Australia. According to TGA, the clinic breached Australian rules by publishing “inappropriate online advertisements for 'peptides' and other prescription-only products.”
Peptide Clinics Australia told the Federal Court it would remove the content from its website late last year. However, the Australian Department of Health found the company continued to advertise peptides, leading to the filing of amended legal documents in March. Peptide Clinics Australia went into liquidation shortly after the filing of the amended documents. A Federal Court hearing of the amended case against Peptide Clinics Australia is due to take place in June.
, Legal Update
India Assigns Risk Categories to Imaging Scanners, Other Recategorized Devices
The Central Drugs Standard Control Organization (CDSCO) has assigned risk categories to newly notified medical devices. DCGI’s action comes months after the Indian government outlined plans to bring many of the devices under the more stringent drug regulatory system.
As of April 2020, India will treat all CT, MRI, PET and X-ray imaging equipment and other devices as drugs, thereby empowering CDSCO to oversee approvals to import, manufacture and market the products. Ahead of that change, CDSCO has assigned risk categories to the products subject to the regulatory reclassification as part of its implementation of the Medical Devices Rules, 2017.
CDSCO has put most of the devices scheduled for reclassification in Class C, reflecting a belief that they pose a moderate to high risk. All of the reclassified imaging equipment, plus defibrillators and dialysis machines, are in Class C.
India put bone marrow cell separators in Class B, a lower risk category. Separators are used to isolate target cells from bone marrow and blood. CDSCO put another two types of device in Class B — blood pressure monitors and digital thermometers — but neither was on the list of products India plans to treat as drugs.
CDSCO assigned risk categories to other types of medical device last year.
China Seeks Feedback on Vaccine Traceability System
China’s National Medical Products Administration (NMPA) has published draft details of its vaccine traceability system. The documents set out the data and technical requirements for a system Chinese officials proposed in the wake of recent vaccine quality scandals.
Confidence in vaccines among Chinese consumers was dented in 2016 and again in 2018 by scandals involving the improper storage of products and substandard manufacturing practices. Officials responded to both situations by proposing to increase oversight of the supply chain and by taking actions including the implementation of a traceability system.
NMPA fleshed out those plans this week by releasing several documents for consultation. The texts set out the data that will be collected by the traceability system and the technical requirements that will support the exchange of data and tracking of products across the supply chain.
NMPA is accepting feedback on the proposals until 15 June.
Philippine FDA Eyes PIC/S Membership After ASEAN Inspection Service Success
The Philippine Food and Drug Administration (FDA) is planning to apply to join the Pharmaceutical Inspection Co-operation Scheme (PIC/S). FDA outlined the plans after qualifying as a listed inspection service of the Association of Southeast Asian Nations (ASEAN).
Securing the ASEAN good manufacturing practice (GMP) qualification suggests FDA is well placed to become a member of PIC/S. To become a listed inspection service for the purposes of ASEAN’s mutual recognition agreement, regulatory agencies must run an operation equivalent to the PIC/S GMP inspection and licensing system.
Specifically, a panel of ASEAN experts must rule that the regulatory agency has adopted or adhered to the PIC/S GMP medicinal product guide and quality system requirements for pharmaceutical inspectorates. The panel also assesses the competency of the agency’s inspectors and determines whether it possesses an adequate legal framework for the inspection and licensing of drugmakers.
The ASEAN panel ruled FDA met these requirements, leading the regional body to make the agency its fifth licensed inspection service after Singapore, Malaysia, Indonesia and Thailand. GMP reports from listed services are accepted by other ASEAN members without the need for further inspections.
Having secured the regional qualification, FDA is now working to gain PIC/S membership. FDA director general Nela Charade Puno recently told the PIC/S leadership of the agency’s intent to apply for membership. The Philippine agency is now preparing a formal submission.
TGA Stops Sending Reminders About Device Annual Reporting Requirements
TGA has stopped sending medical device companies reminders about their reporting requirements. The agency used to contact companies “as a matter of courtesy” but now expects them to comply with the rules without receiving a nudge from its staff.
The change affects manufacturers of Class IIb and Class III devices, as well as active implantable medical devices and Class 4 in vitro
diagnostics. These higher-risk products are subject to annual reporting requirements for the first three years after they join the Australian Register of Therapeutic Goods. TGA expects to receive annual reports by 1 October.
From now on, manufacturers will no longer receive a letter reminding them of the need to submit the report but will still face regulatory action for failing to comply with the requirements.
TGA first told industry representatives of its plans to stop sending reminders at the RegTech Forum on 28 February. No objections were raised at the meeting, according to the agency.
The New Zealand Medicines and Medical Devices Safety Authority
(Medsafe) has highlighted a possible risk of infections associated with the use of Amgen
’s Prolia. Medsafe is asking patients and prescribers to submit reports of adverse events as it gathers data to assess whether additional actions are needed. Medsafe Notice
is hiring people to work on the regulation and inspection of the biopharma industry. NMPA Notice