Asia Regulatory Roundup: TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
 
TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires
 
Australia’s Therapeutic Goods Administration (TGA) has cleared pharmacies to advertise puffers and other salbutamol inhalers during the bushfires affecting the country. The temporary relaxation of the advertising restrictions is intended to help spread information about the availability of inhalers.
 
As TGA clarified days after relaxing the advertising rules, there is no shortage of salbutamol inhalers in Australia. GlaxoSmithKline and other manufacturers have the stock to meet demand. However, the bushfires have cut some pharmacies off from normal supply routes. Coupled with increased demand as a result of the air pollution, the localized supply disruption has affected stock levels in some areas.
 
Those factors informed TGA’s decision to temporarily relax rules on advertising salbutamol inhalers. By allowing pharmacies to tell people with asthma and chronic obstructive pulmonary disease that they have inhalers in stock, TGA thinks it can make it easier for people to access drugs they need.
 
Pharmacies need to ensure they have adequate stock before running promotional campaigns. If a pharmacy advertises salbutamol inhalers despite not having stock, TGA will consider the promotion to be misleading and in breach of the advertising code. TGA wants pharmacies to amend or remove online advertising if their supplies of salbutamol inhalers run low.
 
The temporary relaxation of the advertising restrictions is due to last until the end of April. Advertisements for salbutamol inhalers that run after that date could lead to sanctions and penalties for pharmacies.
 
TGA’s own operations are still being affected by the bushfires. Last week, TGA warned the closure of an office due to poor air quality would limit communication by telephone. Staff returned to the office on Friday, but TGA warned “some ongoing issues” remained.
 
TGA Notice, Shortage Statement, More
 
J&J and Sandoz Affected as TGA Suspends Remaining Ranitidine Medicines
 
TGA has suspended more ranitidine medicines, completing this phase of its action against the class of products. The latest batch of suspensions affects 74 heartburn products, including some sold by Johnson & Johnson and Novartis’ Sandoz.
 
In November, TGA suspended 23 ranitidine medicines from the Australian Register of Therapeutic Goods (ARTG). The suspensions came one month after TGA tests of 34 ranitidine medicines sold by 10 companies found most products on the market in Australia may contain levels of the carcinogenic contaminant N-nitrosodimethylamine (NDMA) that exceed the official limit.
 
Now, TGA has hit ranitidine medicines not affected by its original action with suspensions from the ARTG. The latest action affects 74 ranitidine medicines, including J&J’s Mylanta Ranitidine and Sandoz’s Ranital Forte.
 
The suspensions are due to start on 28 January and last for six months. However, in practice, the temporary suspension of the products from the ARTG could be made permanent. As it did when it unveiled the first set of suspensions, TGA said there are grounds for canceling the medicines from the ARTG “on the basis that the quality of the goods is unacceptable.”
 
J&J, Sandoz and the other companies affected by the TGA suspension now have a window in which to make the changes needed to keep their products on the market. TGA will want to be reassured the products have adequate safety and quality before it lifts the suspensions.
 
The approach taken by TGA contrasts with that of the United States Food and Drug Administration (FDA), which has opted against taking a blanket action against ranitidine medicines so far. Companies have voluntarily pulled ranitidine medicines from the US market but some groups think FDA should do more to protect patients from products that may contain unsafe levels of NDMA.
 
ARTG Suspensions
 
Malaysian MDA Posts Guidance on Supplying Devices for Education
 
The Malaysian Medical Device Authority (MDA) has released guidance on supplying unregistered products for use in educational and marketing demonstrations. MDA used the guidance to outline when a company can benefit from the exemption and the process for obtaining it.
 
Under Malaysian law, only registered medical devices can be imported, exported or placed on the market in the country. However, a later law, finalized in 2016, established exemptions to that rule. One of the exemptions permits companies to manufacture or import unregistered medical devices for use in demonstrations for educational or marketing purposes.
 
The guidance defines when a device is eligible to benefit from the exemption. MDA will extend the exemption to devices presented at trade fairs, scientific conferences and other events, provided they are not used on a human. Marketing materials detailing a device’s features are allowed at the events. A slightly more flexible set of criteria applies to in-vitro diagnostics, which can also be manufactured for “reliability or quality testing” to enhance trust and confidence in the device.
 
Alternatively, MDA will also extend the registration exemption to devices made for educational use. MDA defines educational use as “an activity that is purely for teaching, training or educating people without having any kind of intention related to promoting or marketing and not to be used on human or for the purpose of diagnosis/treatment.”
 
Companies that want to benefit from the exemption need to complete an application form and pay an administrative charge 14 days before they plan to import or supply an unregistered device. If MDA accepts the request, the applicant will be authorized to use the device for educational or marketing purposes for up to 90 days, which can be extended by a subsequent request.
 
Once the exemption period ends, the company must properly dispose of or export the device and file a “post handling” notice with MDA. The regulator expects companies to keep records to prove they exported or disposed of the exempted device.
 
MDA Notice, Device Guidance
 
TGA Tests Show All Measles Vaccines Sold in Australia Meet Quality Standards
 
TGA Laboratories has found no problems with the quality of measles vaccines sold in Australia. The testing wing of the Australian regulator analyzed 11 products sold by GlaxoSmithKline and Merck, all of which met its quality standards.
 
Cases of measles in Australia more than doubled in 2019, rising from 103 to 261, prompting health agencies to encourage people to check if they are vaccinated, particularly before traveling overseas.
 
Against that backdrop, TGA Laboratories ran tests of GlaxoSmithKline’s Priorix, Merck’s M-M-R II and related vaccines designed to protect against the measles virus and other infections. The tests assessed if the 11 vaccines against measles sold in Australia met product specifications and complied with the European Pharmacopoeia standard.
 
TGA Laboratories passed the 11 vaccines, finding all the products met the quality standards. The tested samples represented 738,000 doses shipped in Australia. Separately, TGA has assessed manufacturing records for more than 1 million doses as part of the batch release program it started last year.
 
TGA Notice
 
Other News:
 
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has reported details of another case of neonatal harm caused by tramadol use by a breastfeeding mother. Medsafe received the report, which described weight decrease, feeding disorder and somnolence in the baby during the extended monitoring period that ran for most of last year. Medsafe Notice
 
The Central Drugs Standard Control Organization (CDSCO) has issued another notice about the need for importers, exporters and other groups to register on India’s e-commerce customs portal. CDSCO issued four notices on the topic last year. CDSCO Notice