Asia-Pacific Roundup: TGA guidance clarifies medicinal cannabis advertising rules

Australia’s Therapeutic Goods Administration (TGA) has rewritten its guidance on advertising medicinal cannabis to clarify how the Therapeutic Goods Act 1989 and related legislation apply to the products.

TGA published the first version of the guidance in 2019. Since then, the agency has accused a series of people and organizations of unlawful advertising of cannabis products, most notably when it fined three companies almost AU$1 million ($670,000) in 2022. Those companies account for three of the 12 fines for unlawful advertising of medicinal cannabis that TGA has disclosed since mid-2021.

The updated guidance is almost a total rewrite of the original text. It features new explanations of the types of information that are likely to be seen as advertising and the limits on how companies can refer to medicinal cannabis. TGA emphasizes that the context in which a material is viewed determines whether it is advertising.

“Advertising can be formed from the combination of separate statements, pictorial representations, or designs that, taken together, promote the use or supply of therapeutic goods,” TGA wrote. “Therefore, a reference to ‘plant-based medicine,’ although not expressly referring to medicinal cannabis, is likely to be considered promotional if, based on the surrounding context, it draws the viewers’ mind to medicinal cannabis.”

TGA also added a section on advertising health services that supply or prescribe medicinal cannabis. As TGA states, “Almost all references to a prescription-only medicine in the context of an advertisement for a health service would risk the advertisement becoming an advertisement in relation to a therapeutic good.” Clinics should, therefore, promote services such as pain management, not the product.

Another new section covers advertising directed exclusively to health professionals. Such promotion is permitted, but companies must ensure materials aimed at health professionals are not accessible to the public.

TGA Notice, Updated Guidance

India gives medtech industry two weeks to switch to new national application portal

The Central Drugs Standard Control Organization (CDSCO) is set to use the National Single Window System (NSWS), which is mandatory for some medical device applications, on 15 January, two weeks after the portal came online.

India has developed the NSWS to provide “a one-stop shop for all the approvals required by the investor and facilitate ease of doing business,” CDSCO wrote. The system is independent of the SUGAM and cdscomdonline portals that companies currently use to access the online services provided by CDSCO. India moved some medical device applications from SUGAM to cdscomdonline in 2018.

Now, CDSCO is transferring certain medical device regulatory activities from cdscomdonline to the NSWS. Companies can use the new NSWS portal or cdscomdonline to apply for a notified body registration certificate and licenses to manufacture or import medical devices for clinical investigations, testing, evaluation, examination, demonstration, or training.

CDSCO plans to stop accepting applications for those certificates and licenses on cdscomdonline on 15 January. Indian officials have created an NSWS user guide to help companies transition to the new portal.

The guide provides a screen-by-screen walkthrough of the steps involved in applying via the NSWS. Users can navigate the website, which supports national and state approvals for various activities beyond medtech, and find the medical device application form. The guide then covers all the steps in the application process, from registering on the portal to paying filing fees.

CDSCO Notice

Philippine FDA seeks feedback on adding generics to reference regulator pathway

The Philippine Food and Drug Administration (FDA) has released draft guidelines on its pathways for drug developers who have received authorizations from reference regulatory agencies. FDA proposes adding generic drugs to the list of medicines eligible for the abridged and verification review pathways.

Companies in the Philippines can already use authorizations from certain regulatory agencies to accelerate the review of new drugs, including vaccines and biologicals. FDA plans to change the guidelines to include generics. Multiple sections of the document are being rewritten to state “new and generic drugs, including vaccines and biologicals.” FDA is also planning to add a definition of “generic drug.”

“Generic Drug shall refer to a drug product created to be the same as the reference drug product in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate interchangeability, which means that a generic drug works in the same way and provides the same clinical benefit as its reference drug product,” FDA wrote.

The agency also updated its list of reference regulatory agencies. Korea’s Ministry of Food and Drug Safety and the Saudi Food and Drug Authority are set to become the 15th and 16th organizations recognized by FDA.

Draft Guidelines

Pakistan’s DRAP raids and closes illegal manufacturing plant, steps up surveillance

The Drug Regulatory Authority of Pakistan (DRAP) has raided and closed an illegal drug manufacturing facility. Analysis of samples seized during the raid showed products made at the plant were spurious.

DRAP sent its regulatory field force to the facility in Karachi last month. Samples of eight products, which listed four different manufacturers on their labels, were found. Testing showed the products lacked the stated active ingredients. DRAP warned healthcare professionals, pharmacists and the public that the products will be ineffective and their safety is unknown.

There is a possibility that the products have entered the legitimate supply chain. DRAP is asking its field force to increase surveillance of hospitals and markets and telling pharmacists to check their stock. Any falsified products will be removed from the supply chain.

All the affected products are antibiotics. DRAP believes the products, which include tablets, injections and suspensions, may be used at hospitals and is asking healthcare professionals to monitor supplies. DRAP framed its actions as a “crackdown on illegal manufacturing.”

DRAP Notice

TGA lifts quarantine of saline batches after further tests, stops use of other products

TGA has lifted the quarantine it imposed on four batches of saline after tests and monitoring dispelled its concerns about a risk of infection with Ralstonia pickettii.

The Australian regulatory quarantined multiple products late last year after a cluster of patients tested positive for the waterborne bacterium. TGA found some batches of Interpharma saline products were likely to have been used in the people who tested positive for R. pickettii and identified other products made at the same facility as a potential threat.

Weeks after imposing the precautionary quarantine, TGA lifted its restrictions on four batches of sodium chloride 0.9% 10mL ampoules supplied by Interpharma and allowed the products to return to the supply chain. TGA lifted the quarantine after further testing found no R. pickettii in the batches, and no cases of infection were linked to their use. Interpharma recalled all batches of its 30mL ampoules last year.

In the notice to disclose the lifting of the restrictions, TGA revealed that it has quarantined one other sodium chloride 0.9% product. The precautionary measure affects multiple batches of an eyewash and wound irrigation products made at the same third-party facility as the recalled 30mL ampoules.

TGA Notice

Asia-Pacific Roundup: TGA guidance clarifies medicinal cannabis advertising rules

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