Asia-Pacific Roundup: New Zealand’s Medsafe retains classification of low-dose CBD

RoundupsRoundups | 06 December 2022 |  By 

The Medicines and Medical Devices Safety Authority (Medsafe) has recommended New Zealand keep its current regulatory classification of low dose cannabidiol (CBD), setting the country up to diverge from the position of its neighbor Australia.
 
At its latest meeting, Medsafe’s Medicines Classification Committee looked at the regulatory status of CBD, following the down-scheduling of CBD doses below 150 mg to pharmacy-only status by Australia’s Therapeutic Goods Administration (TGA). TGA agreed to allow 150 mg doses of CBD to be sold over the counter two years ago after finding a lack of serious adverse events at low doses.
 
In its review, Medsafe’s committee considered TGA’s rationale and the evidence behind the decision. The review also looked at regulatory advice from Medsafe and the Medicinal Cannabis Agency and five comments it received after announcing the topic was to be discussed at the meeting. Based on the evidence, the Medsafe committee saw too much uncertainty to recommend allowing over-the-counter sales of low-dose CBD in New Zealand.
 
“The committee noted that CBD medicines did not have an established long-term safety profile, when used as medicines, which would usually be expected to support down-scheduling of a substance. They also noted that there are currently no approved products in New Zealand that have a daily dose of [less than] 150 mg, it was not clear what indications this dose would cover, and therefore there was no clear access issue for these specific medicines,” Medsafe wrote in its summary of the discussion.
 
At the time of TGA’s down-scheduling of low-dose CBD, Australia was also yet to approve a product that met the criteria for sale over the counter.
 
The Medsafe committee also delivered recommendations on the classification of molecules including bilastine, fenbendazole and methenamine hippurate, as well as a string of decisions on the harmonization of the New Zealand and Australia schedules. The harmonization process saw the committee recommend the addition of products including Johnson & Johnson’s Ponvory (ponesimod) and Alexion’s Koselugo (selumetinib) to the New Zealand schedule of prescription drugs.
 
Medsafe Minutes
 
TGA warns advertisers, influencers against promoting Ozempic for weight-loss
 
TGA has warned advertisers and social media influencers that the promotion of Novo Nordisk’s Ozempic (semaglutide) for weight loss is prohibited. Ozempic is a type 2 diabetes medicine that is approved in some countries as a treatment for chronic weight management under the brand name Wegovy.
 
Novo Nordisk won approval for Wegovy in Australia as an adjunct to a reduced-energy diet and increased physical activity for chronic weight management earlier this year. Demand in the US is exceeding supply, with many people learning about the treatment on sites such as Facebook, TikTok and YouTube. The Wall Street Journal reported that the drug went viral on TikTok and YouTube.
 
TGA has alerted advertisers and social media influencers of Australia’s rules on the promotion of prescription medicines and the penalties for breaking them. As a prescription-only medicine, Ozempic cannot be advertised to the public. Australia’s position reflects a belief that the risks of such drugs mean they “should only be determined as an appropriate treatment option in consultation with a professionally trained medical practitioner, rather than on the basis of consumer advertising.”
 
The penalties for breaking the prohibition on advertising include jail time. Criminal financial penalties for individuals and corporations go up to AU$ 888,000 ($598,000) and AU$ 4.4 million, respectively. Civil penalties top out at AU$1.11 million for individuals and AU$ 11.1 million for corporations.
 
TGA Notice
 
Pakistan’s DRAP tells Pfizer to withdraw substandard batch of anti-inflammatory drug
 
The Drug Regulatory Authority of Pakistan (DRAP) has asked Pfizer to recall a batch of its Ponstan Forte (mefenamic acid) 500mg tablets after its Baluchistan drug testing laboratory found the product to be of “substandard quality on the basis of weight variation.” The batch was manufactured by Pfizer Pakistan in 2020.
 
DRAP asked pharmacies to immediately check their stocks of the tablets and stop dispensing the batch. The authority has also asked healthcare professionals to have “increased vigilance” and report any adverse reactions and quality problems to the National Pharmacovigilance Centre.
 
News of the recall emerged shortly after DRAP published a notice about Servier’s Diamicron (gliclazide) 80mg Tablets. DRAP requested the recall of a batch of the anti-diabetic medication after its laboratory found a sample did not comply with a dissolution test.
 
DRAP Notice, More
 
Medsafe misses initial evaluation timeline targets for intermediate and higher-risk filings
 
The average time New Zealand’s Medsafe took to complete the initial evaluation of intermediate and higher-risk applications exceeded its targets in the year up to June 2022.
 
Medsafe aims to complete the initial evaluations of standard intermediate and higher-risk applications in 200 calendar days. The target for abbreviated applications, at both risk levels, is 100 days.
 
The mean and median time to complete initial evaluations of standard higher-risk applications were 232 and 235 days, respectively. The averages represent a wide range, with Medsafe processing one filing in 52 days but taking 365 days to evaluate another. The figures for abbreviated higher-risk applications are similar, with a mean of 200 days, median of 185 days and range of eight days to 396 days.
 
Medsafe’s average evaluation times for intermediate-risk applications mostly exceeded the targets, too. The exception was the median time to complete initial evaluations of standard intermediate-risk filings, which came in a few days under the target.
 
Medsafe Report
 
DRAP warns of falsified copies of medicines from Pfizer, other manufacturers
 
DRAP has issued alerts about suspected falsified products purporting to be manufactured by companies including Pfizer that are on the market in Pakistan.
 
The regulator’s field force found the counterfeit medicines during market surveillance activities in parts of the Punjab province. In Ferozewala, a city close to Lahore, the officials found suspect Xanax (alprazolam) 0.5 mg tablets and sent them for analysis at the provincial drugs testing laboratory. The tests found the product, which was labeled as being made by Pfizer Pakistan, to be spurious.
 
DRAP responded by telling pharmacists to check their stock and stop supplying the spurious batch. The authority wants healthcare professionals to be alert and report any adverse reactions or quality issues.
 
The alert was one of three published by DRAP in quick succession. The other alerts also followed the discovery of suspect products during surveillance in Punjab, with the field force finding falsified Restane (isoflurane) inhalation solution at hospitals in the province and Tablin (pregabalin) capsules in Sheikhupura.
 
Xanax Notice, Tablin Notice, Restane Notice

 

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