Asia-Pacific Roundup: Australia’s TGA proposes temporary GMP exemption to help bacteriophage developers

Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on plans to temporarily exempt bacteriophage therapy products from good manufacturing practice (GMP) requirements.

Bacteriophages are viruses that can infect and destroy bacteria. Scientists have studied the therapeutic use of the viruses for more than 100 years, but development stalled after antibiotics were discovered. In recent years, the rise of drug-resistant bacteria has driven a resurgence of interest in bacteriophages and regulators in countries including the UK have responded with guidance on the modality.

Australian patients have received bacteriophage therapies since at least 2007. Use was initially restricted to patients with life-threatening clinical indications but has begun to expand into lower-risk populations. The shift has changed the unapproved drug regulatory pathway that is used for bacteriophages.

TGA has determined that bacteriophage developers are hindered by a medicines framework that is not fit-for-purpose and a lack of sufficient manufacturing and quality standards. The framework is too rigid to allow the registration of personalized or platform therapies, TGA said, and the lack of standards means there is no minimum benchmark to ensure a level of product safety and quality.

The agency wants to ensure the bacteriophage sector can develop despite those obstacles. That goal led TGA to propose exempting manufacturers of personalized bacteriophage therapies from the need to hold a license for two years. The duration is intended to be long enough to allow the sector to become compliant with GMPs or for TGA to consider an appropriate level of regulatory oversight of phages.

TGA’s exemption will apply to therapies made by medical practitioners and other suitably qualified people for supply to hospitals or institutions in Australia. The agency said it is proposing to restrict the exemption to personalized therapies because the “supply of these products into classical clinical trials has so far been difficult.” Full medicines regulatory requirements will still apply to products made in bulk.

The proposal to allow suitably qualified persons employed by a hospital or institution to benefit from the exemption reflects TGA’s understanding of bacteriophage production. TGA said manufacturing is complex and requires expertise in phage biology, molecular virology, microbial fermentation, and downstream purification. The complexity led TGA to conclude a suitably qualified and trained team is needed.

TGA is seeking feedback to learn whether there is support for a time-limited GMP exemption, as well as to understand whether people agree with the details of its plan. The consultation ends on 13 November.

TGA Notice

Malaysia’s MDA seeks feedback on e-labeling requirements for home-use medical devices

The Medical Device Authority (MDA) has started a consultation into plans to allow the use of e-labels with medical devices sold for home use in Malaysia.

MDA’s current guidance on device labeling requirements, which the agency published in 2022, states that manufacturers of products intended only for use by professionals can provide electronic instructions for use (e-IFU). The draft update extends the eligibility to “certain types of medical devices, including home use medical devices depending on the risk assessment by the manufacturer.”

The agency has proposed changing the requirements for e-labeling to allow home use. MDA’s updated risk analysis plan calls for companies to assess the knowledge and experience of the intended users, the characteristics of the environment where the device will be used, and other factors that could affect the impact of e-IFU.

MDA has also drafted a new subsection on the accessibility of e-labeling. The agency has recommended that e-labels are made available in commonly accessible digital formats, such as PDF and HTML, and that devices carry “direct access” mechanisms such as a QR code or URL. Other requirements include providing a customer support channel to help users who have problems accessing e-IFU.

The agency is running the e-labeling consultation in parallel to two other calls for feedback. MDA’s other consultations cover orphaned, obsolete, and discontinued medical devices. Products are orphaned when the manufacturer or authorized representative has ceased operations. MDA has drafted new guidance on the responsibilities and obligations of facilities when managing orphaned devices.

The draft guidance on obsolete and discontinued medical devices provides similar advice for facilities that are using products that are outdated and no longer being manufactured due to design changes or the evolution of new technologies.

All three draft documents are open for comment until 31 October.

Draft Guidance

Pakistan’s DRAP sets mandatory API sourcing requirements, acts to stop glycol contaminants

The Drug Regulatory Authority of Pakistan (DRAP) has published mandatory requirements for importers of drug substances alongside recommendations on how to prevent contamination of cough syrups.

Children in multiple countries have died in recent years after consuming cough syrups that contained ethylene or diethylene glycol (EG/DEG). The recent deaths of children in India, and resulting investigation into how a substance typically used as an industrial solvent and in antifreeze entered the supply chain, have increased scrutiny of adherence to sourcing standards in Asia.

With the cold and flu season approaching, DRAP has told manufacturers to only procure critical raw materials from qualified vendors. Companies should qualify vendors in accordance with current good manufacturing practice (cGMP) guidelines, DRAP said.

The agency also told drug manufacturers to pre-test all batches of the excipients glycerin, sorbitol, and propylene glycol for EG/DEG impurities before they are used in medicines. Pakistan is providing testing services to companies that lack in-house capabilities. Companies must thoroughly verify and document the results of purity testing, DRAP said.

Officials shared the recommendations on the day they published mandatory sourcing requirements for active pharmaceutical ingredients (APIs). DRAP has told manufacturers to source pharmacopeial-grade APIs from companies that have a valid drug manufacturing license, GMP certificate from a relevant regulatory authority, or a Certificate of Suitability.

DRAP Notice, More

TGA seeks feedback on planned changes to master file rules for blood and plasma products

TGA is running a consultation into plans to update the rules on the master files submitted by Australian importers and manufacturers of plasma and blood products.

Australian regulations require manufacturers of blood and blood components to submit technical master files (TMFs) to show compliance with standards and report production changes. GMP license holders for imported plasma used in fractionation must submit type 2 plasma master files (PMFs). TGA requires the submission of PMFs to stop imports from contaminating Australian plasma products.

Having reviewed the framework, TGA has determined that the legislation lacks a clear requirement for companies to submit initial and annual TMFs and PMFs. The agency has also identified a lack of means to collect fees for the evaluation of the master files.

In response, TGA has proposed changes intended to “regularize existing processes,” make the regulations clearer, and provide a basis to support the collection of fees. The agency said the changes should have a limited impact because the evaluation process and fee structure will remain mostly unchanged.

TGA is running the consultation to understand whether there is support for the changes. The agency has asked for feedback on the potential impact of the revisions. TGA is accepting input until 11 November and plans to use the feedback to finalize its amendments. The agency intends to share implementation timelines and transitional arrangements at a later date.

TGA Consultation

Asia-Pacific Roundup: Australia’s TGA proposes temporary GMP exemption to help bacteriophage developers

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