Asia-Pacific Roundup: TGA publishes advice on transitioning to device reclassification after consultation


Australia’s Therapeutic Goods Administration (TGA) has published guidance on transitional arrangements for the reclassification of certain medical devices. The guidance follows a consultation that revealed the urgent need for clarification of the classification rule and definitions.

The TGA guidelines apply to medical devices which are substances introduced into the human body through a body opening or applied to the skin. As the TGA explains in the document, this definition covers products such as saline nasal sprays, wound protection gels, and topical creams. All products are substances or combinations of substances which are absorbed or locally dispersed in the human body after being introduced through a body opening or applied to the skin.

Rules on devices are expected to change on November 25, when TGA forces them to meet regulatory requirements for Class IIa, IIb, or III products. The devices fall into the highest risk category if the substance is absorbed systemically, the lowest risk group being reserved for products which act locally on the skin or the nasal or oral cavity.

TGA provides examples in the guide, explaining that throat lozenges, which previously belonged to Class I, will now be Class IIa as they are applied in the oral cavity and act locally. The agency cites vaginal gel that maintains pH balance and weight loss capsules that expand in the stomach as examples of Class IIb devices. Both types of devices currently belong to class IIa.

The examples and the broader guidance document address the regulatory boundary between medical devices and drugs. The TGA has stated that many products which are devices in other markets are drugs in Australia because “their mechanism, including the chemical effect in or on the human body, can be characterized as pharmacological, metabolic or immunological” . If the action of a throat lozenge is to reduce irritation and symptoms, TGA will treat the product as medicine.

Promoters of products which meet the definition covered by the guidelines may benefit from transitional arrangements. If a device is listed in the Australian Therapeutic Products Registry (ARTG) with a start date before November 25, the sponsor has until May 25, 2022 to notify TGA that they have a product that needs to be reclassified. The sponsors then have until November 1, 2024 to submit a request to correct the ranking. TGA wants sponsors who remove devices to cancel ARTG registrations by May 25.

The release of the guidance comes months after TGA held a consultation that revealed “a general misunderstanding” about the types of devices covered by the rule. Most of the responses came from consumers who “misunderstood the intent of the consultation due to social media mistakenly suggesting that the consultation was related to individuals’ microchipping.”

TGA ignored consumer responses, but still found signs of confusion in the 17 responses from the device and drug industries. Eleven of the respondents opposed the proposal to fine-tune the regulations but, in TGA’s view, the opposition stemmed largely from misunderstandings, including over whether the changes would force sponsors to comply with regulations on medication.

“There is an urgent need to clarify and provide a definition of absorption, chemical action and physical barriers, both of which help determine whether a product should be regulated as a drug or a medical device,” TGA wrote. . “The proposed improvements would mainly reduce some of the confusion in the language of the classification rules for devices and prevent such products from being classified at the level of Class III. “

TGA Guide, Comments on consultations

TGA Calls for Comments on Creation of Regulatory Pathway for ‘Export Only’ Organic Products

TGA is organizing a consultation on potential regulatory options for “export only” organic products. The idea is to allow the export of organic products with different indications, release specifications or labels to the product approved by TGA.

Currently, exported organic products must be identical to the ARTG product, even if the differences are approved in the importing country. TGA is considering two changes to the export rules, while retaining the option of sticking to the current arrangements. The agency is seeking feedback on the preferred option, foreign agencies’ confidence in Australian products, and associated fees.

The first option is to automatically allow exported biologics to differ from their ARTG entries in several ways, such as clinical indication, specifications, and shelf life. In this model, the active ingredient, primary manufacturing site, and other key attributes should be the same as the ARTG entry.

TGA wants to know if the approach offers enough flexibility for the sponsors. The alternative is to offer an abbreviated screening for biologics intended for export only, as is already the case for drugs. The TGA views the pre-market review as a way to provide assurance to foreign regulators that Australian organic products meet a minimum level of quality and safety. The third option is to keep the current system.

The comments window is open until December 20. After that, TGA will review the comments to let the Australian government know which regulatory option to support. TGA may hold further consultations to discuss details, including fees and charges.

TGA Notice, Consultation document

Indian expert committee asks J&J and Novartis to include 50% of government sites in clinical trials

India’s Subject Matter Experts Committee (SEC) has asked Johnson & Johnson and Novartis to ensure that at least half of the clinical trial sites in studies of their lung disease drugs are managed by the government.

J&J and Novartis separately presented protocols for Phase 2 clinical trials to the committee last week, discussing their plans to study rilematovir in respiratory syncytial virus and CSJ117 in chronic obstructive pulmonary disease, respectively. Discussions focused on risk and benefit assessment, innovation over existing treatments and unmet medical need in India.

The SEC responded by recommending approval of the studies, with caveats including a request to include at least 50% of government sites. The request is one of a rare set of requests made by expert committees.

Central Pharmaceutical Standards Control Organization in India has published recommendations and minutes of 57 SEC meetings since early August, most of which cover multiple clinical trials. Nine of the documents cover conditions for government sites, typically broad usage demands but sometimes quantified demands to make up 50% or more of all centers.

SEC Recommendations

Chinese NMPA Creates Centralized Unit for High Throughput Sequencing Technology

China’s National Administration of Medicinal Products (NMPA) establishes centralized unit for standardization of high-throughput medical sequencing technology.

In disclosing the plan, NMPA released a document detailing its intention to address standards for reference genomes, reagents, data analysis software, tumor diagnostics, and other areas involved in applications. medical sequencing technology. The NMPA has yet to provide exact details on what the unit will do and by when.

The rest of the document lists the 76 people and organizations involved in the initiative. The list features people working in academia, healthcare, and industry alongside representatives from Chinese regulatory agencies.

NMPA Notice (Chinese)

Other news:

The TGA issued AU $ 53,280 ($ 39,130) in infringement notices relating to the alleged export, supply and advertising of counterfeit erectile dysfunction drugs. The statement accuses Performance Online Services of providing products containing undeclared sildenafil, the active ingredient in Viagra. TGA Notice

© 2021 Society of Regulatory Affairs Professionals.


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