Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Industry Argues for Nuanced Approach to Opioid Regulation in Australia
Drugmakers and trade groups have called for the Therapeutic Goods Administration (TGA) to take a nuanced approach to the regulation of strong opioids. The organizations made the comments after TGA outlined ideas for how regulatory changes could curb misuse of high-risk opioids in Australia.
TGA thinks its powers may help to prevent rising prescription opioid use in Australia from spiralling into the sort of crisis seen in the United States. These powers include reducing pack sizes, restricting access to high-dose opioids to specialized prescribers and adding warnings to product labels. The proposals received the broad support of organizations representing healthcare professionals, but the drug industry raised some concerns.
Medicines Australia and Indivior argued against a blanket, one-size-fits-all approach to the regulation of strong, Schedule 8 opioids, but for different reasons. For trade group Medicines Australia, the fear is that TGA will impose restrictions on all Schedule 8 opioid painkillers, rather than consider the risks and benefits of each product.
“Changes made as a result of this consultation process must be based on the individual risk profile of S8 analgesics, and not applied to the entire class in a non-specific fashion, given developing bodies of research and the needs of Australians living with pain,” the trade group wrote.
Indivior’s concerns center on the bundling of Schedule 8 products used to treat pain and those used to treat opioid use disorder, its area of specialization. The drugmaker wants to see TGA differentiate between the two use cases when placing additional restrictions on strong opioids, noting that some Schedule 8 products are used to treat dependence on illicit and prescription opioids. Rules designed to curb opioid misuse could therefore limit access to products that help to manage dependency.
Medicines Australia’s submission lacked specific responses to the eight options put forward by TGA, but Indivior and Mundipharma engaged directly with at least some of the proposals. Both companies expressed doubts about the likely impact of strengthening risk management plans. Mundipharma, a European company with a portfolio of pain products, argued against applying new risk management plans to approved opioid analgesics.
Mundipharma also opposed the addition of label warnings “that are inconsistent with the approved indications,” limits on who can prescribe Schedule 8 painkillers and class-wide changes to the indications in which high-dose opioids can be used.
TGA typically engages with feedback when it publishes the submissions but is yet to provide its take on the responses. Instead, the agency will further discuss how to proceed at a stakeholder workshop this week. TGA will consider the feedback from the workshop alongside the submissions before deciding on which of the proposed regulatory changes to initiate.
, Indivior Feedback
, All Comments
New Zealand Agrees to Staggered Payments to Mitigate Impact of Fee Increases
New Zealand is giving companies the option to stagger the payment of new medicine application (NMA) fees to offset an incoming rate hike. The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) will increase its fees at the start of July but allow firms to only pay the old rate upfront for the rest of the year.
Companies that take up this option will pay the existing NMA fee when they make a submission and receive an invoice for the remainder from Medsafe in January. This would allow a developer of a higher-risk medicine featuring a new active ingredient to pay NZ$ 88,875 ($61,600), not the new rate of NZ$ 102,210, when they file. The company would then pay the remaining NZ$ 13,335 after getting the Medsafe invoice next year.
Medsafe proposed the staggered payment option after drugmakers pushed back against its plans to raise the fees part way through a financial year. Australia’s TGA received similar responses when it tried to raise fees related to good manufacturing practices (GMPs). Companies told Medsafe its fee increases would force them to delay NMA submissions until the first quarter of next year, creating a spike in its workload and making patients wait longer than necessary for new drugs.
The compromise means Medsafe will adopt the new fee structure at the start of July, one month later than initially proposed. That will mark the first time Medsafe has increased its fees since 2006.
Medsafe has reviewed its fees every three years since then, but the presence of a surplus put it off raising its rates in line with inflation. The new fees incorporate all increases in the consumer price index since the last adjustment, meaning they are notably higher than what companies are used to paying. Some companies criticized the jump and favor the small, annual adjustments seen in Europe and elsewhere. Other companies called for Medsafe to give more warning about incoming changes.
DCGI Orders Indian Regulators to Perform ‘Special Operations’ to Enforce Oxytocin Rules
The Drug Controller General of India (DCGI) has told regulatory officials to carry out “special operations” to ensure compliance with new rules on the production and sale of oxytocin.
India has struggled to stop dairy farmers from misusing oxytocin for years. Having seen its earlier efforts fall short, the country is banning private companies from making the hormone for local use and mandating the addition of barcodes to packaging. The changes are set to come into force in July.
In anticipation, DCGI has told his colleagues to perform special operations to prevent and detect the illegal production, distribution and sale of oxytocin. The notice encourages regulatory officials to cooperate with police to achieve these goals whenever required.
TGA Seeks Feedback on Revised Labels for Antihistamines and Antifungals
TGA is planning to revise the labels for sedating antihistamines and certain antifungals. The agency wants to strengthen the advisory labels to ensure the products are not taken by particular subgroups of patients.
The antihistamine proposals apply to all first-generation sedating products. TGA wants to rewrite the advisory label statements to clarify the drugs are unsuitable for children under two years of age. The proposed label also cautions against the use of the products in children under 12, unless recommended to do so by a healthcare professional.
TGA’s other proposals affect the antifungals miconazole and fluconazole. The regulator wants to add a section to the labels of the products telling patients to talk to their doctor or pharmacist if they are taking warfarin. Bleeding or bruising can occur when the medicines are taken together. TGA’s other changes state the antifungals are unsuitable for use in women who are likely to become pregnant.
The agency is accepting feedback on both sets of proposals until 21 June.
, Antifungal Consultation
has provided sponsors with information on its incoming black triangle scheme. The notice states the criteria for inclusion in the scheme, its duration and the responsibilities it places on sponsors. TGA has provided sponsors with wording to add to product and consumer medicine information, plus mockups of black triangle notices, to support compliance with the requirements. TGA Notice
is holding a webinar on the regulation of autologous human cell and tissue products. The one-hour event will discuss incoming changes to the regulation of such products, including restrictions on how they are advertised. TGA Notice