Asia Regulatory Roundup: TGA ties fee increases to inflation, despite medtech opposition

| 30 June 2020 | By Nick Paul Taylor 

Australia’s Therapeutic Goods Administration (TGA) is set to increase its fees by 1.95% in its 2020-2021 fiscal year. TGA decided on the fee increase, which is tied to consumer price and wage inflation, despite a consultation revealing opposition from the medtech industry.
In January, TGA held a consultation to gather industry feedback on three options for changing its fees and charges. TGA stated its preferred option was a 1.95% increase, in line with an indexation factor tied to indices of consumer prices and wages. The agency also discussed maintaining its 2019-2020 fee structure or increasing its rates by 4.3%.
Around half of responses to the consultation supported TGA’s preferred option. One medicine industry body noted it would have supported a 1.95% increase if not for the financial impact of COVID-19 on its members.
Stronger opposition came from the medtech sector, where two industry bodies opposed any fee rises “due to the increasing cost of doing business and inability to pass such costs to their customers to remain competitive in the market.”
The Assistive Technology Suppliers Australia (ATSA) was among the opposition.  “In percentage terms the proposed increases, in part due to the $10 rounding factor, is well above any [consumer price index] growth. Despite the impact of the $10 rounding approach from previous years that is compounding, annual increases have been continually applied. Only a monopoly situation can get away with such increases,” ATSA wrote in its feedback.
Other medtech groups took a different position. Notably, the Medical Technology Association of Australia, which lists Boston Scientific and Medtronic among its members, voiced support for raising fees by 1.95%, while also stating “it is important to also recognise that increases on fees and charges for medical device sponsors come on top of an industry already being punished under fairly dramatic price cuts by the same Government through the cuts in the Prostheses List.”
TGA Notice, ASTA Response
India begins staggered relaxation of restrictions on PPE exports
India’s Directorate General of Foreign Trade (DGFT) has loosened restrictions on exports of personal protective equipment (PPE), shortening the list of medical devices that cannot be shipped overseas.
DGFT prohibited the export of PPE at the end of January. While DGFT went on to lift restrictions on medicines as the pandemic progressed, it maintained the ban on PPE exports. The sole softening of DGFT’s position came in May when it began allowing exports of non-medical masks. The export of all other PPE remained prohibited.
That changed over the past week. First, DGFT narrowed its export ban to medical coveralls, medical goggles, medical masks, nitrile gloves and face shields. The revised policy still banned the export of PPE key to the response to COVID-19 but was more targeted than the previous approach.
DGFT further tweaked its policy on Monday. Under the new policy, DGFT will clear some companies to export up to 5 million medical coveralls a month. Companies need to apply for the right to export coveralls.
DGFT Notice, More
Malaysia’s NPRA creates GMP guidance for traditional medicine manufacturers
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has released guidance on producing traditional medicines and health supplements in compliance with good manufacturing practices (GMPs).
NPRA designed the guidance to help local manufacturers prepare for inspections that assess whether they are ready to start commercial production. That goal led NPRA to divide the main body of the guidance into four parts covering different steps in the process of preparing for and undergoing GMP inspections.
The first step is to ensure the layout of the production plant follows GMPs. NPRA wants companies to submit their proposed layouts for evaluation. Once NPRA has approved the layout, the company can start setting up a quality management system (QMS) and the facility itself.
NPRA is advising companies to assess their own QMS and facilities before NPRA inspectors visit. The self-assessment should ensure the equipment works, check sampling plans are in place, confirm staff are trained and otherwise validate that the facility is ready for inspection. At that stage, companies can submit an application to undergo an inspection by NPRA.
If the inspection identifies significant compliance problems, NPRA will ask the manufacturer to carry out corrective actions before resubmitting to request a second evaluation. NPRA inspectors may also ask a company to withdraw its application if they find the facility is not ready for assessment.
The guidance features a checklist to help manufacturers prepare for inspections.
NPRA Notice, GMP Guidance
TGA reviewing noncompliant cannabis adverts following complaints
TGA has started a review of potentially noncompliant advertising of medicinal cannabis products to the public in response to complaints about certain adverts.
Upon receiving the complaints TGA wrote to the advertisers to ask them to stop unlawful activities. The letters led most of the advertisers to take the actions required to comply with the regulations. However, some advertisers failed to make the required changes. TGA is “considering appropriate action” against the noncompliant advertisers.
TGA plans to focus its resources on complaints about companies that are selling medicinal cannabis products that have not been through the required regulatory checks. The agency thinks such cases of noncompliance pose the greatest risk to consumers.
Other cases of noncompliance relate to the promotion of medicinal cannabis products to the public and the publication of references to serious diseases and conditions without prior approval from TGA.
TGA Notice
Japan’s PMDA moves seminars online through to February 2021
Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has moved all its planned seminars for the next eight months online in response to the COVID-19 pandemic.
PMDA planned to hold eight seminars on topics including pharmacovigilance and GMPs from July 2020 to February 2021, most scheduled to take place in their Tokyo offices.
Under a revised schedule released this week, PMDA has cancelled one GMP seminar and moved seven other events online. The agency noted it will not hold an in-person seminar until February 2021, at the earliest. However, PMDA is yet to rule out holding in-person events before then, stating that “seminars will be mainly delivered online this year.”
PMDA Schedule
Other News:
TGA has published an analysis of drug use after it made low-dose codeine products prescription only in light of doubts about their efficacy. The action triggered a rise in use of high-strength codeine early in 2018. However, the spike was temporary. By 2019, use of high-strength codeine had fallen back to the level it was at prior to the up-scheduling decision. TGA Notice 
China’s Center for Drug Evaluation (CDE) is seeking feedback on draft guiding principles about clinical trials of GnRH agonists, liver cancer treatments and other agents. CDE is accepting feedback on the three drafts for one month. GnRH Agonists, Liver Cancer, More (all Chinese)


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