Asia-Pacific Roundup: TGA seeks feedback on automated decision making for changes to listed medicines
Australia’s Therapeutic Goods Administration (TGA) has started a consultation into proposed changes to support automated decision making (ADM) for listed medicine variation applications.
Under Australian legislation, listed medicines are included in the Australian Register of Therapeutic Goods (ARTG) without pre-market assessment by TGA. Applicants or their authorized representatives self-list the medicines using the TGA Business Services (TBS) system. After listing a product, sponsors can use an ADM process in the TBS system to make most types of variations to their ARTG entries.
TGA’s consultation identifies three issues with the current process. The current guidance supporting the framework for listed medicine change requests is incorrect and unclear, TGA said. Currently, the agency believes its guidance fails to clearly explain when a planned change qualifies as an administrative update, a variation, or a new listing. TGA sees a disconnect between the TBS system terminology used in the guidance and the legislative provisions that define regulatory pathways for proposed changes.
The agency has proposed fixing the issue by revising the guidance to explain the regulatory framework, aligning practical TBS terminology with the legislation, and helping sponsors identify the correct pathway for proposed changes. TGA is seeking feedback on the clarity of its revised guidance.
The second issue is that the legislative basis for variations subject to ADM is not clear or transparent. While the Therapeutic Goods Regulations, 1990, cover variations for registered medicines, sponsors of listed medicines rely on guidance for advice about changing information in the ARTG.
Seeking to address the issue, TGA plans to update legislation. The legislation will identify types of listed medicine variations that must be varied automatically, such as certain changes to product codes, manufacturers, routes of administration, container details, warning statements, ingredient information, and some nonrestricted ingredient quantities. The changes will align listed medicines with the approach used for registered medicines and improve sponsor confidence in TBS outcomes, the agency said.
TGA’s third issue centers on the ambiguity of the terms “restricted ingredient” and “component” in relation to permitted ingredients for listed medicines. The ambiguity concerns “the meaning of ‘restricted ingredient’ where a substance is present as a component of an ingredient, rather than as a permitted ingredient in its own right,” TGA said. That uncertainty is particularly relevant when quantity or concentration limits apply.
The agency is considering resolving the ambiguity either by making its guidance clearer or by updating its regulations. Legislative clarification should provide greater certainty for sponsors and stronger support for accurate and clear ADM outcomes, TGA said. However, changes to the guidance would be faster to implement and ensure the clarification is alongside other relevant information when sponsors navigate change applications.
TGA is accepting feedback on its proposals until 15 September.
Feedback Request, Consultation Paper
Philippine FDA starts consultation into the regulation of combination health products
The Philippine Food and Drug Administration (FDA) is seeking feedback on its definitions of foods, drugs, cosmetics, and devices, as well as on goods that combine multiple types of health products.
Philippine law defines the various classes of health products. However, FDA has found that some stakeholders have struggled to determine which of its units they should contact when seeking authorizations. The situation led the agency to identify a need for guidelines that further clarify how to tell which classification applies to a health good and the rules on combination products.
The draft guidelines list the legislation covering the classification of health products and the attributes, such as the intended use and mechanism of action, that define the categories. Philippine legislation is supported by international documents, including materials from the Association of Southeast Asian Nations, CODEX Alimentarius, and the World Health Organization.
A combination product is regulated by the Center for Drugs Regulation and Research when its primary intended purpose is to administer a pharmacologically active substance to the patient. The Center for Device Regulation, Radiation Health and Research handles the registration of products that primarily act as medical devices, even if they include the secondary use of a drug component.
FDA plans to provide a self-assessment classification tool to help companies determine which center will regulate their products. The results of the tool are non-binding and shall not be interpreted or construed as a regulatory decision of FDA on the classification of the health product, the agency said. FDA has provided examples of products and their classifications.
The agency has proposed a transition period for companies with products that need reclassifying based on the guidelines. Companies with registrations or notifications that expire within five years can submit initial applications under the new classification once their current authorization ends. Applicants with pending submissions can continue working with the center currently handling their filings.
FDA is seeking feedback on the draft guidelines until 17 September.
Indian Pharmacopoeia Commission shares draft monograph revisions for consultation
The Indian Pharmacopoeia Commission (IPC) is seeking feedback on plans to change five monographs in a 2028 addendum to its reference book.
IPC wants to add bacterial endotoxin limits to three of the monographs. The proposals would create caps on the number of endotoxin units per milligram of artesunate, diclofenac sodium, and pantoprazole. The endotoxin limits are the only planned changes to the diclofenac sodium and pantoprazole monographs.
The change to the artesunate monograph includes a clarification of the planned endotoxin rules. The limit applies to artesunate intended for use in the production of parenteral preparations “without a further appropriate procedure for the removal of bacterial endotoxins.”
IPC also wants to add a sterility test requirement for artesunate products that do not undergo a further sterilization procedure. The commission has proposed updating its amifostine monograph with the same sterility test requirement.
Heavy kaolin is the other monograph covered by the consultation. IPC is seeking feedback on plans to add a section on microbial contamination that adds a limit on the total aerobic viable count and total combined yeast and molds.
The draft monographs are open for comment until 1 October.
Saudi FDA authorizes dual glucose-ketone monitor under innovative device pathway
The Saudi Food and Drug Authority (SFDA) has authorized a medical device that continuously monitors blood glucose and ketone levels.
Sales of continuous glucose monitors (CGMs) have grown quickly in recent years as people with diabetes have switched from finger-prick tests to the devices. In May, Abbott received a CE mark for a CGM that also measures ketone, an acid that rises in people experiencing diabetic ketoacidosis (DKA). People can die from DKA, leading Abbott to identify a need to improve early detection of changes in ketone levels.
SFDA reported the approval of a dual glucose-ketone monitor without disclosing the name of the device or the applicant. The agency said it is among the first regulatory authorities globally to grant marketing authorization to the product. SFDA authorized the product under its innovative medical devices pathway, which is designed to accelerate the availability of innovative health technologies in Saudi Arabia.
Other News:
TGA has seized more than AU$120,000 ($86,000) of illicit peptide and anabolic steroid products. The agency took the products from two residential premises allegedly linked to a social media influencer. The influencer allegedly imported and relabeled the products before promoting and selling them online. Retatrutide, a peptide in development at Eli Lilly, was among the seized peptides. TGA Notice
