Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on the repurposing of medicines for the second time in 12 months. The latest initiative builds on the first consultation by seeking views on topics including intellectual property and how to incentivize organizations to repurpose medicines.
TGA draws a distinction between the label extensions that sponsors apply for when a medicine still has patent protection and identifying novel clinical uses of approved products. The consultation focuses on novel clinical uses, particularly for off-patent medicines, because that is where the agency believes there are barriers to the market.
“An extension of indication typically involves a high administrative burden and significant costs for the sponsor. After patent and / or data protection ceases, sponsors are less likely to seek the extension as price reductions reduce the incentive for an initiating sponsor. The return-on-investment is expected to be low or even absent for medicines that are out of basic patent and regulatory protection, ”TGA wrote.
Last year’s consultation focused on reducing regulatory burdens via fee reductions, simplified submissions, exclusivity and more. TGA still sees several challenges, namely: overcoming commercial constraints and addressing intellectual property issues, identifying and prioritizing candidates, and encouraging sponsors to apply for regulation and reimbursement by removing obstacles and / or providing incentives.
To address these challenges, TGA is considering giving priority reviews, waiving or reducing application fees if there is limited commercial incentive, providing a limited period of exclusivity for repurposed on-patent medicines, offering early scientific advice, coordinating with the Pharmaceutical Benefits Advisory Committee ( PBAC) and using foreign data.
TGA also wants to know what forms of coordination support from the TGA and PBAC would be most effective for sponsors; whether giving an exclusivity period to a repurposed indication incentivize sponsors to pursue a repurposing opportunity; how repurposed drugs should they be funded; and whether other options should be considered.
Even those options may be insufficient to realize TGA’s goals. The agency has learned “it can be difficult to encourage a company to make a regulatory submission for a new indication where the medicine’s patent has expired because in such cases, if one company gets TGA approval for an extension of an indication other companies may similarly benefit for a significantly reduced application complexity and fee. ”
To address that barrier, TGA is considering allowing sponsors to apply collectively and share the costs. If exclusivity is offered, it would apply to any sponsor who responds in time. TGA wants to know if sponsors are interested in collective submissions and if there are other ways to overcome the deterrents to being the first company to seek approval for an off-patent medicine in a new indication.
TGA is accepting feedback until April 1; however, the agency expects “further consultation will be required to determine the final approach.”
India seeks feedback on draft medical devices policy
India’s Department of Pharmaceuticals (DoP) has released a draft national medical devices policy for consultation. The policy is part of a push to “help the sector realize its full potential by creating a robust regulatory framework with feedback mechanisms.”
DoP’s consultation comes amid change in the Indian medtech market, with the country aiming to transition from partial regulation of selected medical services to the complete regulation and licensing of all medical devices by October 2023. Regulatory changes will necessitate “more clear articulation in terms of quality assurance and certification, ”according to the draft.
“Quality standards and safety of the devices” sits alongside “regulatory streamlining” on the list of areas of focus identified in the draft. The draft addresses the focus on quality standards, the goal of which is to “provide safe devices to the consumers, in harmony with the global standards,” in a section on DoP’s plans for regulatory streamlining.
To streamline regulatory processes, DoP proposes to create an “online single window portal” for filing medical device applications and the expansion of Indian standard setting bodies “to enhance the level of standardization, certification and quality.” DoP also plans to establish a “coherent pricing regulation,” strengthen the National Pharmaceutical Pricing Authority with “adequate manpower of suitable expertise” and create a code of practice to ensure the ethical marketing of medical devices.
DoP is accepting feedback until 25 March.
Malaysia’s MDA posts PPE guidance for comment
Malaysia’s Medical Device Authority (MDA) is seeking feedback on the minimum performance and labeling requirements for personal protective equipment (PPE).
The draft guidance covers medical PPE, the only type regulated by MDA. The core of the document is taken up by a list of different types of medical PPE and the requirements that apply to them. For example, the guidance states that non-surgical gowns need to comply with 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 within other sterile procedure areas need to comply with Level 3 or Level 4 of the standard, plus an additional standard if they are sterile. The guidance also covers coveralls, which need to comply with Level 5 or Level 6, aprons, head and shoe covers, gloves, face shields and goggles.
The guidance features a brief section on registration requirements that states class A PPE registration does not require an assessment from the Conformity Assessment Body but, for the purpose of registration, “an establishment shall submit the complete test report to the Authority during the registration process. ”
MDA is accepting feedback until 25 March.
Philippine FDA proposes delay to the transition to harmonized requirements
The Philippine Food and Drug Administration (FDA) has released a draft text about the transition to the Association of Southeast Asian Nations (ASEAN) harmonized technical requirements for medical devices.
In an earlier notice, FDA granted the medtech industry until March 31 to apply for a Certificate of Medical Device Notification (CMDN). Under that notice, from 1 April organizations would have needed to have at least applied for a CMDN to manufacture, import, export or sell medical devices in the Philippines.
Now, the FDA has proposed a delay to the timeline. FDA now plans to allow Class B, C and D medical devices that are already on the market to continue being manufactured, imported, exported and sold without a CMDN until 31 March 2023. The delay means companies now need to have at least applied for a CMDN by 1 April 2023 to continue operating.
TGA has cleared Biocelect to file for approval of the COVID-19 vaccine Nuvaxovid in children and adolescents. Biocelect, operating on behalf of Novavax, plans to apply for provisional registration in individuals aged 12 years and up next month. A filing for use in children aged five to 11 years is planned for later in the year. TGA Notice
© 2022 Regulatory Affairs Professionals Society.