Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
CFDA Posts Guidance on Security of Connected Medical Devices
China Food and Drug Administration (CFDA) has released guidance on the security of connected medical devices. The guidance details the factors companies should consider when seeking to register a device with data storage and exchange capabilities for sale in China.
CFDA is aiming the guidance at Class II and III devices that feature network connectivity to enable electronic data exchange or remote control — be it via Wi-Fi or wired connection — or the means to store data for transfer later. The agency, like other regulators, fears security problems with such devices could compromise patient privacy and lead to users being injured or killed. CFDA wants medical device developers to take steps to mitigate these risks before filing to register a connected product.
These steps start with an assessment of the security of the device in the context in which it will be used. CFDA wants developers to identify assets related to the device that could have value to an individual or organization, potential threats to security and the ways the product is vulnerable to attack. This review should encompass the life cycle of the device, from production through to maintenance. Armed with this knowledge, developers can take risk-control measures commensurate with the threats posed to their devices.
Part of the challenge is to ensure devices remain secure when used in the real world. The guidance acknowledges device developers partly cede control once a product is in use, but requires them to remain involved in security throughout the life cycle. Applicants are responsible for ensuring their devices, interfaces with other equipment and the network security are sufficient for the safe and effective operation of the product.
Having established this grounding of who is responsible for what, the guidance delves into some of the details that go into ensuring the security of connected medical devices. The document covers the technical features developers can use to enhance security, such as encryption and firewalls, and the management of security updates. Other topics include the need to develop a plan for maintaining the device and declare certain information when seeking registration of a product.
The guidance is set to come into force at the start of next year.
CFDA Notice (Chinese)
India Establishes Regulatory Process for Exporting rDNA Products, Vaccines
The Drug Controller General of India (DCGI) has formed a regulatory process for gaining clearance to export recombinant DNA products and vaccines. If applicants submit a covering letter, purchase order and other documents as requested, DCGI plans to issue clearances within 10 days of receipt.
Dr. GN Singh, the DCGI, set out the process for obtaining an export no objection certificate (NOC) for unapproved rDNA products and vaccines in a memo to his fellow regulators and the industry. In the memo, Singh commits to the 10-day turnaround for export NOCs and details the documents companies must provide when filing for clearance.
Singh wants exporters to submit five documents: a covering letter, purchase order, manufacturing license, per forma invoice and registration certificate. The memo features an explanation of what details applicants must include in each document.
Covering letters, documents Singh calls “an important part of the application,” must state the goal of the submission and list all the supporting files included in the request for clearance. Other details to include in the covering letter include the dosage form and pack size of each product, the quantity due to be exported and the signature and stamp of the authorized signatory.
Singh has also included a list of seven points companies should consider when filing for an export NOC. The list is designed to ensure exporters include all the necessary information in their filings and, as such, features lines such as “the applicant shall identify the premises where the drug will be manufactured.”
Pakistani Regulators Raid Office of Multinational Company as Stent Scandal Escalates
The Drug Regulatory Authority of Pakistan (DRAP) has raided and sealed the office of a multinational company as part of its action against a stent scandal. DRAP took the action after the Federal Investigation Agency (FIA) accused hospitals of unnecessarily implanting cardiac stents.
FIA posted a report, originally from The Express Tribune, of DRAP’s action against the multinational company. The raid of the sales office reportedly found 40 unregistered stents and expired infusions. DRAP conducted the raid after FIA found evidence government hospitals were using unregistered stents, despite the regulator having cleared 55 products for use in the country.
Officials at FIA also claimed hospitals were giving stents to some patients who did not need them. Other patients reportedly paid to have a stent installed, only for the doctor to fake the procedure. The report also claims there is evidence of overcharging. The Honorable Chief Justice of Pakistan (HCJP) Mian Saqib Nisar took the claims seriously enough to put out a statement and ask FIA to present a report on the subject.
The list of stents registered by DRAP includes products from major medtech companies, such as Boston Scientific and Medtronic.
FIA Update, HCJP Notice, DRAP List
NPPA Lowers Prices of 33 Drugs by up to 50%
The National Pharmaceutical Pricing Authority of India (NPPA) has lowered the prices of 33 drugs by up to 50%. NPPA’s latest batch of actions moves the number of drugs it has acted against in the past nine months beyond 600.
One-third of the products affected by the latest round of cuts are coming under price control for the first time. The 11 drugs were part of the almost 200 products added to the National List of Essential Medicines the last time India expanded the list. Among the products coming under price control for the first time are the chemotherapy procarbazine, antiretroviral medication zidovudine and the antibiotic cefixime.
While the 11 products are coming under price control for the first time, the costs of different formulations of some of their active ingredients were already capped. Different formulations of the gastroesophageal reflux disease drug omeprazole feature on both the list of 11 new products and the 22 that were already under price control. NPPA has lowered the price of the capsule formulation of omeprazole, which was already capped but at a higher level.
NPPA is threatening to pursue companies that fail to comply with the newly capped prices. “The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with interest thereon,” the price watchdog wrote.
NPPA Order, The Economic Times, More
CFDA has released draft rules on the production of food for medical use. The text covers CFDA’s expectations of companies that manufacture formula foods for people with certain medical conditions. Safety management, personnel and the facility itself are among the topics addressed in the guidance. CFDA is accepting feedback until the end of February. CFDA Notice
The Therapeutic Goods Administration (TGA) of Australia has reported a shortage of 5mg tablets of carbimazole, a treatment for hyperthyroidism. To address the shortage, TGA has cleared a product sold in the United Kingdom for use in Australia. The shortage stems from a delay in the manufacturing schedule. TGA NoticeTGA
has posted a medical device safety update. TGA Update