Asia Regulatory Roundup: Australia Runs out of EpiPen Jr Ahead of Release of Contaminated Batch

RoundupsRoundups | 10 December 2019 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Australia Runs out of EpiPen Jr Ahead of Release of Contaminated Batch
TGA has warned that Australia has run out of Mylan’s epinephrine injection EpiPen Jr. A shipment from the US is due to arrive around 17 December, meaning EpiPen Jr will be unavailable in Australia for close to two weeks.
Mylan alerted the Australian public to a shortage of EpiPen Jr last month, pinning the blame for the supply constraints on manufacturing delays at Pfizer’s Meridian Medical Technologies. Last week, Mylan followed up with a notice stating that the product is out of stock in Australia.
In between the two notices from Mylan, TGA revealed it has agreed to allow Mylan to supply a batch of EpiPen Jr that failed quality specifications. The batch is one of several found to be contaminated with pralidoxime, a drug used to treat people poisoned by pest-control chemicals. 
While the presence of pralidoxime caused the batch to fail some required quality specifications, TGA thinks the risks posed by the EpiPen Jr shortage are greater than the contaminant’s potential harm. That position reflects the low levels of pralidoxime in the epinephrine injectors. The batch is due to arrive in Australia on or “soon after” 17 December.
TGA Notice, More
New Zealand’s MCC Recommends Banning OTC Sales of Codeine Products
New Zealand’s Medicines Classification Committee (MCC) has recommended classifying all products that contain codeine as prescription medicines. The recommendation follows more than two years of debate about how to regulate the painkiller.
MCC discussed the classification of codeine more than two years ago. At that time, the committee recommended classifying products that feature codeine in combination with other active ingredients as prescription products. MCC proposed reclassifying products that only contain codeine as restricted medicines, meaning that use would be limited by age, dose and duration of treatment. However, the Minister’s Delegate requested more information and the changes were never implemented.
Now, MCC has returned to the topic. At a recent meeting, MCC recommended recategorizing all products that contain codeine as prescription medicines. The proposal would harmonize practices in New Zealand with those of Australia, which triggered the initial review of the classification of codeine by prohibiting over-the-counter (OTC) sales in response to safety concerns.
The time lag between Australia taking action and New Zealand following suit meant MCC was able to review the experiences of the neighboring country before making a recommendation. In making its recommendation, MCC reviewed a study that found poisoning calls fell significantly after codeine was reclassified in Australia. The study found limited evidence of harm arising from the change.
MCC is now accepting objections to its recommendations for two weeks. If the objections show MCC failed to properly consider all the benefits and safety concerns, or breached protocol, the committee will review its position. Otherwise, attention will turn to the question of how long the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) will give affected groups to adapt.
“Medsafe reassured the Committee that an implementation plan on the proposed recommendation will be developed in consultation with stakeholders and that it will be communicated to the sector to ensure a smooth transition. Medsafe advised that implementation will be carefully planned to ensure that patients and health care professionals will be informed and educated, and industry will be engaged to ensure a smooth transition,” MCC wrote in the minutes of its meeting.
Medsafe Notice, Meeting Minutes
TGA Seeks Feedback on Changes to Paperwork for Exporting Products
Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on plans to end the need for exporters of medical products to submit hard copies of certain paperwork.
TGA’s current approach dates back more than 15 years. As such, the agency requires companies to send it hard copies of all export documents. TGA is now considering permitting the submission of electronic documents.
Before making the change, TGA wants feedback from affected groups. Specifically, TGA has asked whether any benefits would arise from allowing the submission of electronic schedules. TGA also wants to know whether there are benefits to it providing traceable post for hard copy certificates.
TGA posed the questions as part of the release of draft documents on the export of medicines and export certification for medical devices. The documents describe the regulations covering the export of medicines and medical devices, as well as the process for applying to ship products out of Australia. 
The consultation follows a period in which TGA has become better at processing requests related to exports within its target times. In its 2018 to 2019 financial year, TGA processed 87% of applications for export-only medicines on time, up from 70% the previous year. TGA tracked an even bigger improvement in the processing of export certification applications. The proportion of medical device applications processed on time increased, too.
TGA is accepting feedback until 3 February.
TGA Notice
TGA Creates List of Comparable Overseas Bodies for Complementary Medicines
TGA has identified the comparable overseas bodies (COBs) developers of complementary medicines can rely on to bring products to market in Australia. COBs in the European Union and US are among the organizations to have met the criteria established by TGA.
In response to the Medicines and Medical Devices Review, TGA moved to help companies use COB assessments in their filings to sell complementary and listed OTC medicines in Australia. That effort by TGA has now manifested in criteria for determining whether an overseas body is comparable and an initial list of organizations that make the grade.
TGA will allow companies to use certain evaluations from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) to inform its assessments of the safety, quality and efficacy of their products. The TGA criteria permit the use of reports from other agencies in one or two of those areas, but only evaluations from EMA and FDA can inform safety, quality and efficacy.
The list of what reports can be used in which contexts may be updated in the future. TGA will add a new body to the list if its evaluation reports consistently meet the COB criteria, which look at factors such as the transparency of decision-making and use of international guidelines.
TGA Notice
NMPA Approves China’s First Biosimilar Copy of Roche’s Avastin
The National Medical Products Administration (NMPA) has approved Qilu Pharmaceutical’s biosimilar version of Roche’s Avastin. NMPA said the approval marked the first time it has cleared a biosimilar copy of the cancer drug for use in China.
Multiple companies including Beijing Mabworks Biotech, Henlius and Innovent Biologics are working on biosimilar copies of Avastin, also known as bevacizumab. NMPA informed the race to develop an Avastin biosimilar by publishing a document detailing factors to consider when designing and running clinical trials of copies of the blockbuster biologic.
Qilu won the race, picking up NMPA approval of its asset this week. How much being first to market matters remains to be seen. With multiple other companies likely to bring Avastin copies to market, pricing pressures may make ability to control the cost of goods sold the key competitive advantage.
NMPA Notice (Chinese)
Other News:
The Philippine Food and Drug Administration published its 2019 Citizen’s Charter. The document provides information on many regulatory processes. Citizen’s Charter


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