Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China Fires Top Regulatory Officials Over Vaccine Oversight Failures
The Chinese authorities have ousted senior regulatory officials for their roles in the vaccine scandal engulfing the country. Ding Jianhua, who led two departments at the agency, was dismissed along with five other senior officials.
In explaining the dismissals, authorities accused the Chinese National Drug Administration (CNDA) and its predecessor, the CFDA, of failing to provide sufficient supervision or perform strict enough inspections. The authorities view the shortcomings as a dereliction of duty that left loopholes open for companies to exploit. The loopholes came to light when Changsheng Biotechnology was accused of falsifying data and producing ineffective vaccines.
Ding topped the list of fired officials released by CNDA. The regulator served as director of both the Center for Food and Drug Inspection and the drug registration unit at CFDA, giving them oversight of the units that should have identified wrongdoing at Changsheng and taken action. Months passed between regulators finding evidence of possible misconduct and products being recalled.
CNDA revealed the dismissal of Ding alongside the firings of five other regulatory officials. Some of the other dismissed officials were directors or deputy directors at regulatory units involved in the supervision of the drug industry. Another was an investigator at a supervision unit, while the sixth was a vice president at the National Institutes for Food and Drug Control (NIFDC).
A seventh official, NIFDC Director Li Bo, was ordered to “make profound self-examinations” but looks to have avoid being dismissed.
The dismissals are part of a broader attempt to hold officials accountable for the vaccine scandal. A former national drug regulator is the subject of a criminal investigation and regional leaders including a deputy governor and mayor have lost their jobs.
CNDA released details of the dismissals days after sketching out the lessons it had learned from the scandal and how it plans to block the newly identified regulatory loopholes. The plan is light on details of concrete regulatory changes, but they are coming. Revisions to laws and regulations are in the pipeline.
TGA Posts Guidance on Use of Overseas Authorizations in Device Filings
The Therapeutic Goods Administration (TGA) has posted guidance on the use of overseas approvals in the authorization of medical devices in Australia. TGA released the guidance to coincide with its acceptance of documents from more overseas regulators and assessment bodies in Australian filings.
Australia has a history of accepting certificates from European Union notified bodies as evidence that devices comply with conformity assessment procedures. Following the expert review of regulations, the Australian government tasked TGA with making more use of the work of comparable overseas regulators. That led to plans to use authorizations from the United States, Canada, Japan and the International Medical Device Regulators Forum’s Medical Device Single Audit Program.
With TGA set to start accepting paperwork from the expanded list of agencies in filings this month, it has released guidance and an accompanying question and answer document on the topic. The texts set out what overseas evidence TGA will consider in filings and what effect it will have on the process in Australia.
TGA will accept scientific evidence and documentation from the above-mentioned countries and organizations, provided it covers a device with the same design and intended purpose as the one being put forward for authorization in Australia. If the evidence meets these criteria, TGA will use it to truncate its own assessment of the device.
The accompanying Q&A clears up questions not specifically addressed in the guidance, such as what happens if certain types of paperwork are used in submissions for Class I, IIb or III medical devices.
Following Recalls, China Seeks Feedback on Revisions to Valsartan Standard
The Chinese Pharmacopoeia Commission is planning to revise its standard for valsartan to eliminate the risk of N-nitrosodimethylamine forming during production. Regulators around the world have recalled valsartan over the past month after learning that companies shipped products contaminated with the carcinogen.
Initially, Zhejiang Huahai Pharmaceutical was the only company known to have made contaminated products. However, in recent weeks evidence that other companies shipped contaminated valsartan ingredients has accrued, suggesting a systemic problem with how the blood pressure drug is made and tested.
The Chinese Pharmacopoeia Commission has responded to the escalating safety scare by revising its valsartan standard. The revised standard states manufacturers of valsartan need to check their drugs are free from N-nitrosodimethylamine using gas chromatography and mass spectrometry. The draft standard walks through the testing process and sets a limit for the presence of the contaminant.
Chinese officials are accepting feedback on the draft for one month.
India Maintains Knee Implant Price Caps for Another Year
India’s National Pharmaceutical Pricing Authority (NPPA) has left orthopedic knee implant price caps unchanged for the next year. NPPA had the opportunity to lower or increase the price ceilings but opted to keep them at the current level.
Officials at NPPA set the original price caps in 2017. Since then, the price watchdog and the industry have seen the real-world effects of the ceilings. This experience informed NPPA’s annual review of the price cap but failed to persuade the agency it had erred in setting the prices originally. All of the prices will stay the same for another 12 months, barring a surprise change between now and then.
The maintenance of the ceilings is further evidence of NPPA’s willingness to resist the arguments of multinational device manufacturers affected by its caps, which reduced the prices of knee implants by more than 50%. NPPA previously made only minor changes to its cardiac stent price caps.
CDSCO Relieves Deputy Controller of Additional Duties in Senior Shakeup
The Central Drugs Standard Control Organization (CDSCO) has relieved a deputy drugs controller (DDC) of additional duties in a shakeup of the roles of its senior staff.
CDSCO appointed Aseem Sahu as head of its medical device division in 2014. Sahu was also in charge of activities related to blood banks at CDSCO’s headquarters. CDSCO has now stripped Sahu of these responsibilities.
“[Sahu] ... is relieved of his above mentioned additional charges immediately. He may handover the possession of the room allotted to him in FDA Bhavan to the undersigned,” Vum Mang, the deputy director of administration at CDSCO, wrote in a note.
CDSCO disclosed details of the change in Sahu’s role on the same day as it issued statements about changes elsewhere in its organization. DDC Ravi Kant Sharma will take charge of the medical device unit, where he will receive support from an assistant drugs controller. CDSCO assigned new roles to three other DDCs, one of whom just joined the agency’s headquarters from a regional office.
, Joining Order
, Work Order
is set to move oxytocin
from Schedule H to Schedule H1. The reclassification strengthens the conditions imposed on the dispensing of the hormone. Schedule H1 was created in 2014 to curb the misuse of antibiotics. Indian officials now hope the restrictions will have a similar effect on the use of oxytocin, which farmers have given to cows to boost milk production. Gazette Notification
has published its assessment report on Sanofi
’s high-dose trivalent influenza vaccine, Fluzone. TGA Report