Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
CNDA Sends Team to Oversee Regional Regulatory Investigation Into Fosun Unit
The China National Drug Administration (CNDA) has sent a team to oversee an investigation into a subsidiary of Shanghai Fosun Pharmaceutical. CNDA took the action after Chongqing Food and Drug Administration (FDA) performed a surprise inspection of Fosun’s Chongqing Pharmaceutical Research Institute (CPRI) unit.
CPRI has been in the crosshairs of regulatory agencies since inspectors from the United States FDA (US FDA) visited it in 2016. A subsequent warning letter accused the unit of deleting entire chromatographic sequences and repeating analyses until they generated acceptable results. The failings led FDA to advise CPRI to bring in outside support to help it look into the extent of the problems and devise a global corrective action and preventive action plan.
Since then, the Fosun subsidiary has worked to improve its operation, but there are signs the process is ongoing. US FDA issued a Form 483 after visiting the facility last year to perform a pre-approval examination of its quality control system.
Now, Chongqing FDA has published a letter purportedly written by a CPRI whistleblower. The letter, which covers similar topics to those raised in the US FDA warning letter, triggered a drop in the share price of Fosun. Chongqing FDA performed a surprise inspection of CPRI to investigate the claims made by the whistleblower shortly before publishing the letter late last month.
Chongqing FDA is yet to reach a conclusive opinion on the compliance of CPRI. The initial assessment did not identify any illegal violations. Chongqing FDA was unable to contact the whistleblower as they provided incorrect contact information.
CNDA is involved in the investigation. The national drug agency has tasked Chongqing FDA with investigating the allegations made by the whistleblower and sent some of its own inspectors to keep tabs on the probe.
, CNDA Notice
(both Chinese), Fosun Statement
Responding to EMA Ruling, TGA Proposes Limiting Access to Modified-Release Paracetamol
Australia’s Therapeutic Goods Administration (TGA) is considering limiting access to modified-release formulations of paracetamol. TGA is planning to require patients to talk to pharmacists to buy the medicines to increase the likelihood of them being taken safely.
The safety of modified-release paracetamol was called into question in Europe last year. After looking into the topic, the Pharmacovigilance Risk Assessment Committee (PRAC) recommended pulling the drugs from the market. The recommendation of the European Medicines Agency (EMA) committee reflected concerns about the difficulty of treating people who overdose on modified-release forms of paracetamol.
TGA responded to the work of PRAC and EMA by performing its own review and seeking the input of the Advisory Committee on Medicines. This led TGA to propose a less dramatic change to the status of the formulations than that advocated by PRAC.
The agency is proposing to change the status of modified-release paracetamol to “pharmacist only.” Currently, the medicines are classed as “pharmacy only,” meaning people can buy them without first discussing the risks they pose with a pharmacist. The proposed change would “give pharmacists the opportunity to check that patients are using the medicine correctly and counsel them on the importance of not exceeding the recommended dose,” TGA wrote.
TGA has started the upschedulung process. The agency is accepting feedback on the proposed change until the end of October. The feedback will inform a March 2019 meeting of the Advisory Committee on Medicines Scheduling that will discuss whether to change the schedule of the formulations. For now, consumers can still buy modified-release paracetamol without first talking to a pharmacist.
China Shares Details of Incoming Changes to Medical Device Adverse Event Reporting
CNDA has detailed the changes to medical device adverse event reporting that will come into force at the start of next year. The incoming regulations place new adverse event monitoring and reporting requirements on companies that sell medical devices in China.
Once the rules come into force, manufacturers will need to have adverse event monitoring systems. When the system detects a potential adverse event, the manufacturer must immediately look into the matter, take any required emergency control measures and inform regulators of the situation within seven days.
The rules give CNDA new powers to punish organizations that fail to comply with these requirements and are unwilling to cooperate to improve their systems. The agency can force companies to suspend production and stop sales of their devices. If that happens, the company will need to apply to get its operation going again.
CNDA and its predecessor have spent the past few years reassessing their approach to the reporting of adverse events related to medical devices. These efforts led to the publication of proposals late in 2015, which in turn form the basis of the rules that will come into force on 1 January. The new rules will replace adverse event monitoring and reporting requirements from 2008. Since then, China has taken an array of actions to strengthen and modernize its regulation of medical devices.
Legal Dispute Delays Indian Restrictions on Oxytocin Manufacturing
The Delhi High Court has delayed the implementation of restrictions on oxytocin while a legal case is resolved. Indian regulators had planned to enforce the rules at the start of the month, but the plan is now on hold until October at the earliest.
Government officials proposed prohibiting the production of oxytocin by private companies earlier this year. At that time, the rules were expected to come into force in July. The government later delayed the start date until September. Now, the Delhi High Court has forced the government to push back the date again.
The high court took the action after Neon Laboratories, All India Drug Action Network and Mylan subsidiary BGP Products filed a case against the government. The justices who will rule on the case questioned the likely efficacy of the government’s actions and therefore hit pause on changes.
“Considering all circumstances, we are prima facie of the opinion that complete prohibition … on manufacture, sale and distribution for domestic use of oxytocin should be suspended for one month,” the justices overseeing the case said, according to The Indian Express
The delay will give parties involved in the dispute time to file written submissions arguing their cases. The high court is accepting submissions until the next scheduled hearing on 12 September.
, The Indian Express
has set up a Facebook
page. The agency held a soft launch of the page last month and invited a small group of people to follow it. Since then, TGA content has been viewed 50,000 times on Facebook. Having tested out the platform with the small group, TGA is now opening the page up to everyone. TGA will use the page to share information about its activities with the public and healthcare professionals. TGA Notice
has published details of its hiring plans. The agency is looking to recruit four people to managerial positions and two people to professional and technical roles. CNDA is accepting applications for the jobs until 12 October, after which it will put the most promising candidates through a written test, interview and physical examination. CNDA Notice
has published details of a change to the law covering package inserts. Gazette Notification