Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China Tightens Genetic Material Rules, Places Extra Restrictions on Foreigners
China is set to tighten restrictions on the use of human materials including DNA, organs, blood and tissues. The rules require foreign organizations to team up with local partners to use human genetic materials and otherwise place extra limits on their access to samples taken in China.
Politicians in China signaled their intention to rethink the regulation of human genetic material last year in light of its growing importance as a strategic resource. By Chinese standards, some people have misused that resource in recent years, leading the Chinese Ministry of Science and Technology to fine organizations including AstraZeneca and Beijing Genomics Institute last year.
A new set of tighter standards will apply from 1 July onward. The government communicated the new rules in a State Council Order at the start of the week.
The rules prohibit foreign organizations, individuals and institutions from collecting human genetic resources in China, and from distributing existing resources overseas. To access China’s potentially vast pool of genetic material, foreign organizations will need to work with local partners.
Foreign organizations and their Chinese partners will face punishment if they fail to comply with the restrictions. If a foreign organization violates the rules, Chinese authorities may issue a fine of up to RMB 10 million ($1.4 million). Higher fines are possible if the foreign organization is deemed to have made a certain amount of illegal income.
Chinese companies risk being fined if they improperly provide foreign organizations with access to human genetic materials. Local organizations can also be fined for breaching other stipulations on the use of genetic materials and for using false information in licensing applications.
To monitor the sector, the Chinese government plans to carry out surveys of human genetic materials and create a registration system for important resources in specific regions.
The tightening of access to genetic material comes shortly after a report
prepared for the U.S.-China Economic and Security Review Commission raised concerns about Chinese access to data on people in the United States. The report notes that Chinese biotechs are “amassing large collections of clinical and genetic data on US residents,” adding that in theory “access to private information on security sensitive US persons creates a risk of blackmail.”
TGA Set to Upschedule Paracetamol in Face of Opposition From GSK
Australia’s Therapeutic Goods Administration (TGA) is set to reclassify modified-release paracetamol as a Schedule 3 drug despite opposition from organizations including GlaxoSmithKline.
The Australian Department of Health proposed moving modified-release paracetamol from Schedule 2 to Schedule 3 last year after concluding that the current regulatory status of the painkiller “poses an unacceptable to risk” to the public. That conclusion was based on analyses that found the dosage form offers “little benefit” over standard-release paracetamol and has a “complex and unpredictable pharmacokinetic profile” that makes it hard for physicians to treat patients who overdose.
An interim decision by the Advisory Committee on Medicines Scheduling (ACMS) concurs with the position of the health department. As it stands, TGA is set to reclassify modified-release tablets or capsules that contain 665 mg or less of paracetamol as Schedule 3 products, meaning patients would need to talk to pharmacists to buy the drugs. Higher-dose products are only available by prescription.
“Up-scheduling is likely to reduce the risk of either inadvertent overdose and the more common deliberate overdose due to greater oversight of sales. Pharmacists would be able to exert some control over purchase for suspected problematic or inappropriate use,” ACMS wrote in its interim ruling.
ACMS reached that interim decision at a meeting despite some of the public submissions referred to the committee expressing a different view. GSK, for example, opposed rescheduling modified-release paracetamol, setting out its reasoning in a 73-page submission that defended the safety and benefits of the formulation.
GSK argued that modified-release paracetamol “offers considerable benefit” over conventional forms of the drug in the management of osteoarthritis. To support its case, GSK cited studies showing that modified-release paracetamol is associated with reduced need for opioids and improved adherence. GSK also pointed to Royal Australian College of General Practitioners (RACGP) guidelines on the use of modified-release paracetamol.
RACGP submitted feedback, too. The professional general practice organization was more equivocal about the merits of rescheduling but ultimately concluded that the change may do more harm than good.
“The RACGP believes there is a lack of evidence to suggest that oversight by pharmacists will lead to improved patient outcomes, especially improved drug safety,” the organization wrote in feedback on the proposal. “Such a step may have unintended consequences on patients, including reduced access and cost implications because of the supply environment.”
There is still time for that argument to win out. The interim decision is open for comment until 4 July.
, GSK Feedback
, RACGP Feedback
China Calls out NuVasive and Local Companies Over Device Quality Issues
China’s National Medical Products Administration (NMPA) has found fault with medical devices made by companies including San Diego-based NuVasive. NMPA’s roundup of its medical device oversight activities listed one batch of spinal products from NuVasive among the nonconforming technologies.
NuVasive was called out by NMPA over the size of its device. Separately, NMPA found fault with the surface roughness of one batch of spinal devices manufactured by a Chinese company.
NMPA communicated the reports of spinal device quality issues alongside details of assessments of the conformity of other types of product. The list features alanine aminotransferase assay kits, pneumatic compression products and other devices, the vast majority of which are made by Chinese companies.
The regulator published details of its quality enforcement activities the day before it released a list of the medical device standards that will be revised or introduced in the coming months. NMPA’s list features 27 standards that it plans to address between now and December 2020.
, Standards Timeline
Clinical Trial of First Tetravalent Norovirus Vaccine Cleared to Start in China
China has approved the start of a clinical trial of a tetravalent norovirus vaccine. Institut Pasteur of Shanghai (IPS) is developing the vaccine with Anhui Zhifei Longcom Biopharmaceutical.
Norovirus, commonly known as "winter vomiting bug," affects around 20 million people a year in the United States, resulting in hospitalizations and significant economic impacts. There are no approved vaccines against the virus, despite the efforts of companies including Takeda and Vaxart. Takeda ran trials of a bivalent vaccine seven years ago. Vaxart started a Phase Ib bivalent vaccine trial this year.
IPS thinks the tetravalent vaccine set to begin testing in China could prevent up to 90% of norovirus infections. However, preclinical research on the merits of other tetravalent vaccines is inconclusive, with one study
finding they are less effective at stimulating broad antibody responses.
’s Center for Drug Evaluation
(CDE) has held a symposium to discuss reforms to the regulation of traditional Chinese medicines. The symposium follows a two-year period in which the average annual approval rate for clinical applications increased from 47% to 86%. CDE Notice
officials have met with their counterparts at the Dutch Medicines Evaluation Board
. The meeting served to familiarize each side with the other’s regulatory system ahead of more in-depth talks. CDE Notice