Asia Regulatory Roundup: China Opens Food and Drug Center of Excellence

RoundupsRoundups | 27 November 2019 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Suspends Ranitidine Medicines Ahead of Possible License Cancellations
The Therapeutic Goods Administration (TGA) has suspended 23 ranitidine medicines from the Australian Register of Therapeutic Goods (ARTG). TGA suspended the products for six months but thinks there are grounds to ultimately cancel the medicines from the ARTG altogether.
Last month, TGA presented results from tests on 34 ranitidine medicines sold by 10 companies. The tests, which covered 135 batches, suggested most ranitidine medicines available in Australia contained more than 0.3 parts per million (PPM) of N-nitrosodimethylamine (NDMA), meaning they breached the internationally agreed limit for the carcinogen. Back then, TGA said it was considering “suspending the registration for products which cannot demonstrate adequate safety and quality.”
Now, TGA has revealed its response to the high levels of NDMA. The Australian regulator has put 23 ranitidine medicines on a six-month suspension that will run from 16 December to 16 June. Apotex, Arrow Pharma and Sandoz are among the companies with products affected by the suspension.
Ranitidine products absent from the list of suspended medicines include two ARTG entries sold by Arrow Pharma under the Chemists’ Own brand. The products were two of five ARTG entries with batches TGA found to contain levels of NDMA below 0.3ppm. Batches taken from two other Arrow Pharma ARTG entries and one Sandoz entry also passed the TGA test but were still suspended.
TGA uses suspensions to protect patients while giving manufacturers the chance to address issues with their products. In the case of the ranitidine medicines, if the affected companies fail to make changes to reassure TGA of the safety of their products, they face the prospect of losing their place on the ARTG permanently.
In the section on the grounds for suspension for each of the 23 products, TGA wrote that, “It is likely there are grounds for cancelling this medicine from the ARTG ... on the basis that the quality of the goods is unacceptable.” The affected manufacturers now have a little more than six months to stop that happening, although in some cases TGA extends suspensions to give companies more time to fix problems with their products.
TGA Notice
New Zealand’s Medsafe to Ban Sale of Migraine Drug Next Year
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is set to ban the sale of the Cafergot migraine drug. Medsafe decided to stop the distribution of the AFT Pharmaceuticals’ product after concluding the benefits no longer outweigh the risks.
Cafergot, which contains ergotamine tartrate and caffeine, is used in the treatment of acute attacks of migraine with or without aura in adults. The drug was approved in New Zealand in the late 1960s. Other countries also used ergots such as ergotamine tartrate in the past but authorities including the United Kingdom’s National Institute for Health and Care Excellence and the German Society of Neurology now recommend against their use.
The recommendations against the use of ergots are underpinned by the lack of well-documented efficacy evidence from prospective studies and concerns that they have worse safety and tolerability profiles than other migraine drugs, such as triptans.
Adverse events linked to Cafergot in migraine are relatively rare, with the Centre for Adverse Reactions Monitoring (CARM) identifying five reports as of the end of June. One of the reports covered a case of potential pancreatitis that led the Medicines Adverse Reactions Committee (MARC) to look into the drug.
A report presented to MARC said there were “fewer reports than predicted,” although the authors think that may be because use is relatively low and, as an old drug, people may have stopped reporting side effects. The report identified close to 1,800 patients who used Cafergot in New Zealand last year.
Healthcare professionals who provided feedback for the report said Cafergot is rarely prescribed today, although one person noted they know of a “small handful” of patients who use it safely. Knowledge of those people led that healthcare professional to say, “It would be a shame to lose [Cafergot] altogether.” Some of the other healthcare professionals expressed similar sentiments.
Despite that, MARC recommended the withdrawal of Cafergot at a meeting earlier this year. That led to a Medsafe notice last week that set 1 May as the date of the withdrawal of Cafergot from the New Zealand market. The timeline reflects MARC’s recommendation of a six-month transition to enable patients to safely move to new medicines.
Medsafe Notice
Malaysia’s MDA Seeks Feedback on Orphaned Medical Device Guidance
Malaysia’s Medical Device Authority (MDA) has published draft guidance on medical devices that are in use but no longer registered. Products can end up in this situation when their manufacturer or authorized representative stops operating.
Such products, which MDA calls “orphaned medical devices,” pose challenges as they are in use but no longer have a representative that is responsible for them. To ensure the ongoing safe use of these devices, MDA wants healthcare facilities that use orphaned medical devices to send it a notification covering details of the product.
The notification must identify a person who is responsible for the medical device. This person must live in Malaysia and hold a top managerial position at the organization that uses the device.
MDA’s focus on the seniority of the responsible person reflects the obligations the orphaned medical device status places on healthcare facilities. In the absence of a manufacturer or typical authorized representative, the healthcare facility is responsible for the risk of using the orphaned medical device and the monitoring of its safety and performance.
The draft guidance is open for feedback until 30 November.
Draft Guidance, MDA Notice
China Opens Food and Drug Center of Excellence in Beijing
China has opened a food and drug center of excellence in Beijing. The United Nations Industrial Development Organization (UNIDO) is supporting the initiative to help China establish a harmonized, competency-based food and drug safety training system.
Representatives of UNIDO, the China International Center for Economic and Technical Exchanges and China Food and Drug Administration's Institute of Executive Development (CFDAIED) signed off on the creation of the center of excellence earlier this year. The initiative has a total budget of $500,000, a little more than one-third of which is due to be spent this year. UNIDO reports $32,000 has been spent so far.
The investment is intended to equip China to create a country-wide food and drug safety training system that is in line with, and recognized by, international standards and organizations. Specific tasks include international training through profiling, benchmarking and capacity building.
UNIDO will help out with the overall capacity development framework and provide support with the food safety side of the project. CFDAIED will leverage the food sector work to design drug-related content, possibly with the support of UNIDO. The project is due to run until October 2021. 
NMPA Notice (Chinese), UNIDO Project
Other News:
TGA has extended the deadline for submissions of feedback on its review of the regulation of some self-testing in vitro diagnostics. The consultation began in late September and was initially due to end on 22 November. However, TGA extended the deadline this week, pushing the date on which it will stop accepting feedback back until 6 December. TGA Notice


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