Asia Regulatory Roundup: TGA Seeks Feedback on Efficacy Claim Labels for Non-Prescription Medicines

Welcome to our Asia Regulatory Roundup, our weekly roundup of the top regulatory news in Asia.

TGA Seeks Feedback on Efficacy Claim Labels for Non-Prescription Medicines

The Therapeutic Goods Administration (TGA) of Australia is pushing ahead with plans to allow makers of certain medicines to claim regulators have assessed the efficacy of their products. TGA is seeking feedback on which medicines should be allowed to make the claims and how they will affect product labels.

Interest in allowing efficacy claims grew out of the assessed listed pathway proposed following the expert review of regulations in Australia. Products that follow the pathway will undergo safety and quality self-certification and pre-market efficacy assessment by TGA prior to being listed in the Australian Register of Therapeutic Goods (ARTG). This process is more rigorous than the listed pathway used by vitamins and herbal medicines but less arduous than applying for registration.

Given the extra work involved, the expert review proposed allowing sponsors to make efficacy claims. The government agreed in principle in the belief efficacy claims would incentivize sponsors and inform consumers. Responses to an earlier consultation on the topic were broadly positive, too.

That has brought TGA to the point it is ready to refine its thinking. The consultation seeks to answer the three main outstanding questions about efficacy labels, starting with which products will be allowed to make the claims.

The efficacy claim idea stemmed from plans to bring complementary medicines to market under the assessed listed pathway. Limiting efficacy claims to these products is one option, but TGA is worried that doing so would provide assessed listed complementary medicines with an unfair advantage over registered complementary medicines and over-the-counter products. To counter that risk, TGA is considering allowing all assessed listed or all pre-market assessed, non-prescription medicines to make claims. TGA’s consultation document presents the last, all-encompassing option as the fairest.

The other two questions consider what the claim should look like and how it will be used on labels. TGA has mocked up proposed visual identifiers, stating the product is either “TGA assessed” or “TGA efficacy assessed.” The agency is considering whether to include a label statement, such as  “Efficacy evidence has been assessed by the TGA,” and if so how it should be worded. The consultation also discusses the color, size and placement of the label.

TGA puts forward what it sees as the pros and cons for the various options in the consultation, but wants to hear from interested parties before finalizing its plans. The agency is accepting feedback on the topic until 21 June. TGA expects to start approving listed complementary medicines in the third quarter.

Consultation Document

CDSCO Threatens Legal Action Against Newspapers That Seek to ‘Tarnish’ its Image

The Central Drugs Standard Control Organization (CDSCO) has threatened legal action against media outlets it believes are trying to tarnish its image. CDSCO thinks legal and criminal actions may enable it to establish the source of the “wrong information” provided to some newspapers and periodicals.

The threat stems from CDSCO’s belief “certain elements” are seeking to tarnish its image by providing false information to news publications. CDSCO is particularly concerned about pieces published in the periodical Union Territory Independent, which it accuses of writing defamatory articles about its officers.

The Drug Controller General of India (DCGI) has tried to address the matter without success.

“[The editor] was requested to meet DCGI and provide some evidence with regard to the article published, so that CDSCO could take appropriate action,” Arun Sharma, director of administration at CDSCO, wrote in an office order. “The editor has failed to meet DCGI in spite of various opportunities given to him which shows that he doesn’t have any evidence in support of allegations levelled in the defamatory articles.”

Sharma followed up by stating CDSCO is contemplating “suitable legal and criminal action” against the editor. The filing of a police complaint is one possibility, as CDSCO seeks to identify “the people behind this.” In the meantime, Sharma has told all stakeholders, including CDSCO officers, to refrain from activities “which are solely aimed at tarnishing the image of CDSCO and its officers.” Sharma also warned against sharing news on social media, pointing to IT legislation to support his statement.

CDSCO Order

Australia Provides Guidance on Child-Resistant Medicine Packaging

Australia’s TGA has released guidance on the requirements for child-resistant drug packaging. The guidance complements legislation that is set to come into force at the start of October.

The new legislation references standards for reclosable packages that emerged after publication of the outgoing text. TGA’s guidance states sponsors can choose to comply with any one of the five standards referenced in the legislation. The agency has no preference about which standard is used. Whatever standard is chosen, sponsors should provide instructions about how to open and close the package, either in graphical form or clearly written English.

Other changes to the legislation include the removal of a list of example substances that must use child-resistant packaging. Lawmakers took that step to eliminate the risk readers would see the list as exhaustive. TGA notes the change in its guidance and writes out a list of criteria sponsors can use to ascertain whether their product needs to use child-resistant packaging.

Manufacturers of such products must adopt child-resistant packaging and generate evidence that it will work in the real world. For example, the child-resistant closure on a bottle containing 100 tablets to be taken once a day must withstand at least 100 openings and closings without deteriorating.

Companies can choose to comply with either the outgoing or incoming legislation until the end of September. After that, Australia will sunset the old legislation, forcing manufacturers to switch to the recently adopted rules.

TGA Guidance

TGA Updates Position on Data Requirements for Inhaled Drugs and Nasal Sprays

TGA has updated its guidance on inhaled drugs and nasal sprays. Version 2.0 of the text changes the scope of the guidance, provides more information about application pathways and clarifies how to establish therapeutic equivalence.

The original 2013 document paid little attention to medicines covered by prescription pathways and processes. That has changed in the new version. While the guidance still links out to the prescription medicine registration process, it now also provides advice on new and revised registrations of OTC medicines that are evaluated as prescription medicines. Metered-dose asthma inhalers and nasal corticosteroids fall into this group.

TGA has also expanded sections on demonstrating therapeutic equivalence. The guidance covers the choice of comparator — strongly recommending the use of an Australian reference product — and provides specific advice for different types of products. Nasal sprays, nebulized medicines and inhaled metered-dose products each get their own section.

Other changes include the removal of sections outside the bounds of the revised scope and general reformatting to make the document easier to read and understand. The guidance is now divided up into sections on application pathways, quality, therapeutic equivalence and changes to the formulation or delivery device.

TGA Guidance

Other News:

CDSCO has clarified when ISO requirements for in vitro systems that measure glucose concentrations in capillary blood samples will come into force. The glucometer test strip standard, ISO 15197:2013, is set to come into force 36 months after the Bureau of Indian Standards issued its final notice on the rules. That makes 18 October 2019 the implementation date. CDSCO Notice