Asia-Pacific Roundup: TGA adds remote and hybrid GMP inspections to guidance on licenses and certification

TGA has added information about remote and hybrid inspections to its guidance on Australian manufacturing licenses and overseas good manufacturing practice (GMP) certification.
 
The update affects a section on determining the inspection typeand scheduling the inspection. In older versions of the guidance, the section only covered scheduling the inspection as there was only one type of inspection: in person. Now, with COVID-19 necessitating remote and hybrid inspections, TGA has updated the guidance to advise manufacturers on how it will choose how to assess them.
 
“We have developed a process to enable inspectors to undertake remote and/or hybrid GMP inspections where appropriate. This process is a risk-based model where we evaluate various options available for inspections on a case-by-case basis, in consultation with relevant staff at each specific manufacturing site,” the guidance states.
 
TGA has also changed a subsection on setting up inspections, replacing a line about how it will arrange all travel related to the on-site inspection with a sentence about how it will “undertake inspection related administrative arrangements, where applicable, including inspection costs, flights and travel allowance,” again reflecting the move away from a fully on-site model.
 
TGA Guidance
 
TGA readies industry for January switch to new therapeutic good advertising code
 
Australia’s Therapeutic Goods Administration (TGA) has published details of the transition to the new advertising code. TGA will bring the Therapeutic Goods Advertising Code 2021, which features changes such as simplified mandatory statement requirements, into effect on 1 January but will give the industry until 30 June to transition to the new rules.
 
The 2021 Code is designed to be easier to read and apply, while still meeting the requirements for a legal instrument prepared under the Therapeutic Goods Act 1989. TGA held a consultation on the planned changes earlier this year, culminating in the text that will take effect next month.
 
In a notice to describe the incoming changes, TGA highlighted six key revisions in the 2021 Code. The list of changes is topped by the simplified mandatory statement requirements, which TGA adopted after conducting consumer research into the topic. The research led TGA to reduce the number of mandatory statements and to differentiate between warnings for online and in-person sales. TGA plans to run a consumer education campaign next year to support the simplified requirements.
 
The other changes include the clarification of the rules around testimonials and endorsements in advertising. TGA has decided to retain the 2018 Code rules allowing genuine unpaid testimonials in advertising while clarifying that paid or incentivized testimonials are prohibited. The ban includes testimonials from influencers, people engaged in the production, marketing or supply of the goods and current or former healthcare professionals.
 
TGA has expanded the list of product samples that can be offered in, or as, advertising of therapeutic goods to cover face masks and gloves, certain sanitary products, hand sanitizers, certain nicotine replacement therapies and COVID-19 rapid antigen tests. The products must be entered in the Australian Register of Therapeutic Goods. TGA is planning guidance on how requests for additions to the list will be assessed.
 
TGA briefly highlighted three other changes in the 2021 Code. The agency is consolidating the prohibited representation rules, revising definitions to improve clarity and expanding the rules on “safe and proper use” to “prohibit an advertisement from causing undue alarm, fear or distress.”
 
TGA Notice
 
India’s NPPA accepts industry request to move to quarterly medical device reporting
 
India’s National Pharmaceutical Pricing Authority (NPPA) has acquiesced to industry pressure to allow manufacturers of certain medical devices to submit stock reports quarterly rather than monthly.
 
NPPA began requiring manufacturers and importers of oxygen concentrators to file monthly stock reports in June, expanding the program beyond the bare metal stents, drug-eluting stents and knee implants that it subjected to price controls in 2017. The requirement to share details of all oxygen concentrators manufactured, imported, sold and exported came amid surging demand.
 
Industry associations have pushed back against the monthly reporting requirement, leading NPPA to agree to a new quarterly model. The revised requirement starts from the quarter ending December 2021.
 
NPPA Notice, More
 
Australian court imposes $2M fine for unlawful advertising of medical devices
 
The Federal Court of Australia has ordered Oxymed Australia and its director Malcolm Hooper to pay a total of AU$3 million ($2.1 million) for unlawful advertising of hyperbaric oxygen therapy devices.
 
Oxymed needs to pay AU$2 million for breaching the Therapeutic Goods Act 1989 by advertising medical devices intended to administer hyperbaric oxygen therapy. The court imposed the fine of AU$1 million on Hooper “for aiding, abetting, counselling or procuring the contraventions of the Act by Oxymed.”
 
The court found Oxymed's advertising was “intended to engender in the unscientifically trained and vulnerable reader a perception of credibility as to the claims of [hyperbaric oxygen therapy] as a treatment” for conditions including Alzheimer's disease, COVID-19, stroke, HIV/AIDS and cancer.
 
In imposing the fines, the court raised concerns that, while hyperbaric oxygen therapy poses limited risk of direct harm to patients, the ads could cause significant damage by leading patients with conditions such as HIV/AIDS and cancer to defer or avoid “orthodox evidence-based treatment.” The court also identified a risk of substantial financial harm to patients.
 
TGA Notice
 
Provisional approval of Pfizer vaccine in kids leads flurry of TGA nods for COVID-19 products
 
TGA has granted provisional approval to a batch of COVID-19 products. The batch includes approval to use the Pfizer-BioNTech COVID-19 vaccine Comirnaty in people aged five years and over.
 
Like many of its regulatory peers, TGA has provisionally approved a lower dose of Comirnaty for use in children aged five to 11 years on the strength of clinical data showing it generates a comparable immune response to that seen in older age groups. The safety profile is similar in younger children, too, with mild injection site pain, fatigue and headache among the most common adverse events.
 
TGA disclosed the provisional Comirnaty approval in between notices about two COVID-19 therapies. First, TGA granted provisional approval for Roche’s Actemra in the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Australia has procured Actemra, which is in short supply, to treat COVID-19.
 
Later, TGA disclosed the provisional approval of Celltrion Healthcare’s anti-SARS-CoV-2 antibody Regkirona. The approval covers Regkirona in the treatment of mild-to-moderate COVID-19 in adult patients.
 
Pfizer Notice, Roche Notice, Celltrion Notice
 
Other News:
 
The Drug Regulatory Authority of Pakistan (DRAP) has published an advisory on importing drugs with short shelf lives. DRAP is advising manufacturers and importers of products with short shelf lives to apply for pre-import permission. However, DRAP will consider post-import cases in “very exceptional circumstances of Force Majeure” DRAP will charge a fee for each batch. DRAP Notice
 
TGA has begun trialing a new tool to search the Australian Register of Therapeutic Goods (ARTG). The beta version of the new tool is currently available alongside the older ARTG search function. TGA, which has warned that users of the new tool may encounter minor issues, is seeking feedback from people who trial the beta search function to inform further development. TGA Notice