Asia-Pacific roundup: TGA advises on drug reuse – again

The Australian Therapeutic Goods Administration (TGA) is asking for feedback on drug reuse for the second time in 12 months. The latest initiative builds on the first consultation by seeking views on issues such as intellectual property and incentives for organizations to recycle medicines.

The TGA distinguishes between label extensions, which sponsors apply for when a drug is still patent protected, and the identification of new clinical applications of approved products. The consultation focuses on novel clinical applications, particularly for off-patent medicines, where the agency believes market barriers exist.

“An extension of the indication is typically associated with a high level of administration and considerable costs for the sponsor. After patent and/or data protection has expired, sponsors are less likely to request renewal because discounts reduce the incentive for an initiating sponsor. Return-on-investment for drugs that no longer have basic patent and regulatory protection is expected to be poor or even absent,” TGA wrote.

Last year’s consultation focused on reducing regulatory burdens through fee reductions, simplified filings, exclusivity, and more. TGA still sees several challenges, namely: overcoming commercial limitations and addressing intellectual property issues, identifying and prioritizing candidates, and encouraging sponsors to seek regulation and reimbursement by removing barriers and/or providing incentives.

To address these challenges, the TGA is considering prioritizing reviews, waiving or reducing application fees when there are limited commercial incentives, providing a limited period of exclusivity for repurposed patent medicines, offering early scientific advice, and engaging with the Pharmaceutical Benefits Advisory Committee (PBAC) and using third-party data.

TGA would also like to know what forms of TGA and PBAC coordination support would be most effective for sponsors; whether granting a period of exclusivity for a repurposed indication encourages sponsors to pursue a repurpose opportunity; how misappropriated drugs should be funded; and whether other options should be considered.

Even these options may not be enough to achieve TGA’s goals. The agency has learned “that it can be difficult to get a company to submit an application for a new indication when the drug is off-patent, because in such cases, when a company gets TGA approval for a new indication , other companies can similarly benefit for significantly reduced application complexity and fee.”

To remove this obstacle, TGA is considering allowing sponsors to apply jointly and share the costs. If exclusivity is offered, it would apply to any sponsor who responds in a timely manner. TGA wants to know if sponsors are interested in joint submissions and if there are other ways to overcome the deterrent of being the first company to apply for approval of an off-patent drug in a new indication.

TGA accepts feedback until April 1st; However, the agency expects that “further consultation will be needed to determine the final approach”.

TGA notice

India seeks feedback on draft medical device directive

The Indian Department of Medicines (DoP) has published a draft National Medical Devices Policy for consultation. The directive is part of a push to “help the sector reach its full potential by creating a robust regulatory framework with feedback mechanisms”.

The DoP consultation comes amid changes in the Indian medtech market, with the country aiming to transition from partially regulating selected medical services to fully regulating and approving all medical devices by October 2023. Regulatory changes require “clearer articulation regarding quality assurance and certification,” the draft says.

“Quality standards and safety of the devices” are on the list of priority areas identified in the draft, along with “regulatory tightening”. The draft addresses the focus on quality standards aimed at “providing consumers with safe devices in line with global standards” in a section on the DoP’s plans to streamline regulation.

To streamline regulatory processes, DoP proposes creating a “single-window online portal” for medical device application submission and expanding India’s standardization bodies “to improve the level of standardization, certification and quality”. DoP also plans to introduce “coherent pricing regulation,” strengthen the National Pharmaceutical Pricing Authority with “adequate staff and expertise,” and create a code of conduct to ensure ethical marketing of medical devices.

DoP accepts feedback until March 25th.

Draft Policy

Malaysian MDA publishes PPE guidance for comment

The Malaysian Medical Devices Agency (MDA) is seeking feedback on the minimum performance and labeling requirements for Personal Protective Equipment (PPE).

The draft guidance addresses medical PPE, the only type regulated by the MDA. The core of the document is a list of different types of medical PPE and their requirements. For example, the directive states that non-surgical gowns must meet Level 1 or Level 2 of a liquid barrier performance standard. Level 1 and Level 2 cover lower risk applications.

In contrast, surgical gowns intended for use in the operating room or other sterile surgical area must conform to Level 3 or Level 4 of the standard, plus one additional standard if sterile. The guidance also applies to coveralls that must meet Level 5 or Level 6, aprons, head and footwear covers, gloves, face shields and goggles.

The guidance includes a brief section on registration requirements, stating that registration of Class A PPE does not require assessment by the conformity assessment body, but for the purpose of registration “a facility must submit the full test report to the authority during the registration process. ”

MDA accepts feedback until March 25th.

Draft instructions

The Philippine FDA proposes a postponement of the transition to harmonized requirements

The Philippine Food and Drug Administration (FDA) has published a draft text on the transition to the Association of Southeast Asian Nations (ASEAN) harmonized technical requirements for medical devices.

In a previous notice, the FDA gave the medtech industry until March 31 to apply for a Certificate of Medical Device Notification (CMDN). According to this notice, organizations should have applied for at least one CMDN to manufacture, import, export or sell medical devices in the Philippines starting April 1st.

Now the FDA has proposed a delay in the schedule. The FDA now plans to continue to manufacture, import, export, and sell Class B, C, and D medical devices that are already on the market without a CMDN until March 31, 2023. Due to the delay, organizations must now apply for at least one CMDN by April 1, 2023 to continue operations.

Draft Policy

Other news:

TGA has approved Biocelect to seek approval of the COVID-19 vaccine Nuvaxovid in children and adolescents. Biocelect, which works on behalf of Novavax, plans to apply for provisional registration for those aged 12 and over next month. A regulatory filing for use in children ages five to eleven years is planned for later this year. TGA notice

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