Asia-Pacific Roundup: TGA mulls mandating medical device adverse event reporting by healthcare facilities

RoundupsRoundups | 26 October 2021 |  By 

Australia's Therapeutic Goods Administration (TGA) is seeking feedback on plans to make it mandatory for healthcare facilities to report adverse events linked to medical devices. Currently, only manufacturers and sponsors need to report adverse events, and TGA is concerned that longer-term device failures, such as those involving urogynaecological mesh, may present in different healthcare settings to the original procedure.
The consultation grew out of an investigation into transvaginal mesh that identified a need to improve access to timely information about the safety and effectiveness of medical devices. A subsequent action plan for improving the Australian regulatory framework for medical devices backed a TGA review of whether it should be mandatory for healthcare facilities to report adverse events and safety problems with medical devices to the agency.
Now, more than two years after the release of the action plan, TGA has begun a public consultation into the question. The discussion paper and questions posed in the consultation are informed by the talks TGA has held with hospitals, peak bodies, state and territory governments, the Australian Commission on Safety and Quality in Health Care and international regulators this year. While some countries require healthcare professionals themselves to report adverse events, the TGA discussion paper focuses on making healthcare facilities report incidents on their behalf.
In 2020, healthcare professionals accounted for 8% of all medical device reports submitted to TGA. The data led TGA to conclude “a very significant number” of medical device adverse events are never reported under the current voluntary system, potentially because healthcare professionals lack the time to do so, are unaware they can report directly to TGA or tell their hospitals, which then fail to pass the information on.
TGA said making reporting mandatory may enable it to more quickly identify safety signals, detect rare events, “understand a broader range of events that have occurred with specific medical devices,” and take earlier actions in response to emerging concerns. The questions are whether the benefits outweigh the downsides and, if so, how TGA should implement mandatory reporting.
The survey asks respondents whether they support mandatory reporting and whether they see any unintended consequences to the proposed change in requirements. The rest of the survey delves deeper into the practicalities, asking respondents whether any healthcare facilities should be excluded from the reporting requirements and whether any existing laws or requirements prevent mandatory reporting.
Elsewhere, TGA asks about the type of incidents or events healthcare facilities should have to report and whether existing harm metrics can be used to identify reportable incidents. The questions feed into a discussion of whether current reporting systems need to be improved to incorporate symptoms that may be caused by medical devices and the level of symptoms that healthcare sites should need to flag.
TGA is accepting feedback until 13 December.
TGA Notice
Philippine FDA seeks feedback on revised GMP clearance guidelines for foreign companies
The Philippine Food and Drug Administration (FDA) is seeking feedback on revised good manufacturing practice (GMP) clearance guidelines for foreign companies.
FDA created guidelines in 2013 to ensure all imported pharmaceutical products comply with GMPs and to establish an associated database and coding system. The agency released implementing guidelines the next year and later temporarily revised its approach in response to restrictions related to COVID-19, but the core approach has remained unchanged.
The draft guidelines feature a new, extended set of definitions and propose the creation of a Drug GMP Unit under the Field Regulatory Operations Office (FROO). Under the draft proposals, applicants will file online with FROO through FDA eServices. All documents will need to be sent in English, with any translated documents being “clear, legible, accurate and in an official manner in line with the manufacturer’s documentation system.”
As in the past, FDA may grant GMP clearance based on a remote assessment but may also perform an on-site inspection. The validity of clearances issued based on desktop assessments “shall follow the validity of the GMP Certificate or equivalent documents submitted.” GMP clearances based on on-site assessments are valid for three years from the date of inspection.
Other sections of the draft guidelines cover the responsibilities of the qualified person of the drug distributor or importer, as well as specific points related to the categorization of applications, the documentation requirements, and the schedule of fees.
FDA is accepting feedback on the draft until 21 November.
Draft Guidelines
Malaysia updates guideline for registration of drug-device combination products
Malaysia’s drug and medical device regulatory agencies have released updated guidance on registering combination products. The guideline covers the submission of registration and variation applications for products that feature a drug and device element.
Regulation of combination products in Malaysia is determined by whether the drug or medical device is classed as the primary mode of action. The Drug Control Authority regulates products classed as drugs, with the Medical Device Authority handling products classed as medical devices. The guideline explains the process for registering both types of combination product.
In updating the guideline, the Malaysian regulatory agencies have added a new section on the management of post-marketing incidents involving combination products. The new section covers the reporting of adverse drug reactions and other incidents. The reporting process differs depending on whether the device, drug or both elements are deemed to have contributed to the incident.
Final Guideline
TGA starts court proceedings over alleged unlawful importation of face masks
TGA has begun court proceedings against Enviro Tech Holdings and its executive officers over the alleged unlawful importation of surgical face masks.
In March 2020, Australia allowed importers to bring surgical face masks into the country without first adding them to the Australian Register of Therapeutic Goods (ARTG), provided the products were supplied to the National Medical Stockpile under a contract with the Department of Health.
According to the case brought by TGA, Enviro Tech imported 500,000 disposable face masks in August 2020 without having a contract to supply the stockpile or adding the products to the ARTG.
TGA hit Enviro Tech with an AU$13,320 ($10,000) infringement notice for the alleged breach late last year. However, according to TGA, Enviro Tech failed to pay the infringement notice, leading the agency to start legal proceedings in the Federal Court.
TGA Notice
Japan’s PMDA posts English translation of guidelines for bioequivalence studies
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has released an English translation of guidelines on bioequivalence studies of generic products. The translations cover revised guidelines and questions and answers on the topic from the National Institute of Health Sciences.
The guidelines explain how to run bioequivalence studies, dissolution tests and other assessments for various dosage forms, such as oral immediate release and oral extended-release products. The guideline also features a shorter section on non-oral dosage forms and dosage forms for which the need to run bioequivalence studies is waived.
In the Q&A document, the Japanese authorities explain how the guideline differs from the corresponding World Health Organization (WHO) text, pointing to differences in the lot size of test products, the minimum number of subjects and the handling of wide confidence intervals. The Q&A explains why Japan decided to diverge from WHO in those areas.
PMDA Notice


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