Asia-Pacific Roundup: TGA queries on regulation of devices with animal, microbial or recombinant materials

Australia’s Therapeutic Goods Administration (TGA) is running a consultation into the risk classification of medical devices that contain certain materials of animal, microbial or recombinant origin. TGA began reassessing its approach in response to requests to review the risk classification.

Today, TGA treats devices that contain tissues, cells or substances of animal, microbial or recombinant origin as high-risk, Class III products. The agency’s position reflects the risks associated with using the materials when the regulations were established in 2002, partially due to the risk of transmissible spongiform encephalopathies (TSE).

More than 20 years later, TGA is considering whether the risks of the materials have changed sufficiently to reclassify the devices. Last year, the regulator found the risk of transmission of TSEs via blood transfusion is very low and lifted the ban on blood and plasma donors from the UK. The changes came eight years after TGA responded to implementing control measures and subsequent reduction in the incidence of TSEs by allowing manufacturers to self-assess low-risk materials.

Now, TGA is seeking feedback on the risk of certain materials of animal, microbial or recombinant origin; microbial and recombinant materials in general; and using evidence from a broader range of comparable overseas regulators for medical devices that contain the materials.

The administration is considering closer alignment with the European Union. While the Australian rules refer to medical devices that contain microbial or recombinant tissues, cells or other substances, the EU only specifically references products of animal origin.

TGA is seeking feedback on the risks associated with microbial and recombinant materials and asking whether stakeholders have concerns about their removal from the classification rule. If TGA removes the materials from the rule, it will classify devices that contain microbial or recombinant substances based on other classification rules and their intended use. Devices could move to lower-risk classes.

The consultation also covers questions about xanthan gum, gellan gum, cellulose, fish oil, chitosan and alginate. TGA’s analysis shows that the materials are generally considered to be low risk, leading it to propose excluding them from the classification rule. TGA is asking stakeholders for their views on the risk of the materials and the consequences of excluding them from the rules.

Other questions posed in the consultation address the acceptance of evidence from comparable overseas regulators. Only conformity assessment evidence from TGA or the EU is accepted in requests to add specified medical devices to the Australian Register of Therapeutic Goods. TGA accepts evidence from a longer list of agencies for products that are not specified medical devices and is seeking feedback on whether to expand the list for substances of animal, microbial or recombinant origin.

TGA is accepting feedback until 28 July.

TGA Notice, Consultation Document

Philippine FDA starts consultation into draft guidelines on the regulation of stem cell facilities

The Philippine Food and Drug Administration (FDA) seeks feedback on guidelines regulating human cells, tissues, and cellular and tissue-based products and stem cell facilities.

FDA and the Department of Health created the draft guidelines based on their experience enforcing the existing rules, recent advances in cell therapy and international best practices. The insights led to identifying gaps in the Philippine regulations and concerns about delayed authorizations and the coordination of the different bodies involved in the oversight of the technology.

The draft guidelines have three objectives: to provide a regulatory framework for issuing authorizations; to “rationalize and streamline” the existing regulatory processes; and to delineate the jurisdictions of the bodies that regulate human cells, tissues, and cell and tissue-based products. The new rules apply to sites involved in the materials' production, trade, use and promotion.

In the draft, Philippine officials define various terms, describe the general guidelines that apply to each set of stakeholders and outline specific procedural guidelines, including the process for applying for FDA authorization. The section on FDA authorizations details the use of the application portal and each of the subsequent steps in the submission, review and approval process.

The rest of the document describes the roles and responsibilities of FDA and other bodies, such as the Bioethics Advisory Board, outlines the sanction and appeal process and describes the transition period. Existing health facilities licensed by the Department of Health have until 2027 to comply with the new licensing standards.

FDA is accepting feedback until 30 June.

FDA Notice, Consultation Documents

Pakistan’s DRAP updates application process for contract manufacturing; some drug products

The Drug Regulatory Authority of Pakistan (DRAP) has updated the process for applying to produce drugs as a contract manufacturer and clarified the data requirements for products with multiple strengths or fill volumes.

DRAP issued the notifications in response to the recommendations of its registration board. At a meeting earlier this year, the board discussed using Form 5F for contract manufacturing submissions and communicating data on products with multiple strengths or fill volumes.

The discussions have led DRAP to tell contract manufacturers to complete the first module of Form 5F and reference a previous approval with the product development and stability data to satisfy the rules on modules two through five. DRAP applied conditions to the process, requiring manufacturers to use the same source of drug substance, formulation, specifications and container closure.

Separately, DRAP issued a notification to clarify that manufacturers of products with multiple strengths or fill volumes only need to complete Form 5F for one version of each drug. Completing the drug substance section of the common technical document for the other strengths and fill volumes is optional.

Manufacturers that only complete Form 5F for one product version must use the same source of drug substance for all strengths and fill volumes and submit a certificate of analysis when different lots or batch numbers of drug substance have been used to make “various strengths/fill volumes.”

DRAP Notice, More

WHO recognizes Singapore HSA as stringent regulatory authority for high-risk diagnostics

The World Health Organization (WHO) has classified Singapore’s Health Sciences Authority (HSA) as a stringent regulatory authority (SRA) for high-risk in vitro diagnostic (IVD) medical devices.

A national regulatory authority must have stringent quality, safety, and efficacy standards in its marketing authorization review process for health products to be classified as an SRA. HSA’s qualification as an SRA for Class C and D IVDs means diagnostics registered with the agency will qualify for abridged prequalification assessment by WHO.

HSA framed the WHO ruling as potentially beneficial for medical device companies. Major international buyers of medical devices, such as the United Nations agencies, rely on the WHO prequalification program and, as such, the SRA decision means manufacturers can use registration in Singapore as a launchpad for global sales.

HSA Notice

Other News:

Pakistan’s DRAP has scheduled a public hearing to discuss its updated guidelines on applying for a license to operate. DRAP set the deadline for comments on the draft as 30 June and has now called a meeting to discuss the text for 4 July. DRAP Notice

Asia-Pacific Roundup: TGA queries on regulation of devices with animal, microbial or recombinant materials

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