Asia Regulatory Roundup: CFDA Seeks Feedback on Unique Identifiers for Medical Devices

Regulatory NewsRegulatory News | 06 March 2018 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
NPPA Chairman Departs, Sparking Speculation About Role of Hospital Lobby
Bhupendra Singh has “relinquished” his role as chairman of India’s drug pricing watchdog. Singh’s departure from the National Pharmaceutical Pricing Authority (NPPA) comes shortly after he added private hospitals to the list of organizations targeted by the agency.
NPPA disclosed Singh’s departure in a brief statement on Twitter. Singh left the agency on the same day. NPPA is yet to disclose who will replace Singh as its chairman.
Singh has taken up a new role at the National Authority for Chemical Weapons Convention, but the timing and sudden nature of his departure have raised concerns and speculation. Under Singh, NPPA broadened its mission to cover cardiac stents and knee implants. In recent weeks, the agency has also highlighted the four-figure profit margins hospitals add to medical equipment.
The short lag between the publication of the hospital report and Singh’s departure has led people to link the two events. The former NPPA chief is reportedly among those to make the connection.
“Singh was expecting the transfer due to the pressure mounted from the private hospital lobby,” an anonymous NPPA source told The Hindu.
Whatever the reason, the result is NPPA is leaderless at a time when it is working on multiple fronts to bring down the cost of healthcare. The recent review of cardiac stent prices put that topic to bed for another year, but other issues are still on its agenda. A review of the knee implant cap is coming up, and statements by NPPA in recent months suggest it is weighing actions targeting manufacturers of cardiac guidewire, catheters and balloons and considering how to handle hospital margins.
Responsibility for taking on these tasks will now fall on a new leader, who will arrive in the job against a backdrop of speculation that his predecessor was ousted after upsetting influential groups. The new chairman also faces the task of replacing a leader who was popular with many people.
“Singh has taken many positive steps to ensure affordability of medicines and medical devices that discomforted the industry. There was greater accountability to the public because of increased transparency and responsiveness to grievances of patients and the industry. Enforcement was also significantly strengthened with the recovery of hundreds of crores due to overcharging by the industry,” the All India Drug Action Network told The Times of India.
NPPA Post, The Times of India, The Hindu
CFDA Seeks Feedback on Unique Identifiers for Medical Devices
The China Food and Drug Administration (CFDA) is seeking feedback on its medical device unique identifier rules. CFDA, like its peers, wants to link medical devices to unique alphanumeric codes to enable the identification of products as they are distributed and used.
The rules released this week set out how CFDA intends to achieve this goal. CFDA is proposing to give companies some leeway to decide how to meet its broad objectives. The document allows for the use of one- and two-dimensional barcodes, plus optional radiofrequency tags, to identify the medical device. CFDA is encouraging the use of advanced technology but has left some decisions up to firms. 
CFDA shared guiding principles to help companies decide on how to adopt unique identifiers. These principles state that the identifier must be unique, relate to the medical device’s basic features and be compatible with regulatory requirements. 
The agency is accepting feedback on the draft until the end of April.
CFDA Notice (Chinese)
CDSCO Floats Further Restrictions on Oxytocin to Curb Persistent Misuse
The Central Drugs Standard Control Organization (CDSCO) has proposed further restrictions on the hormone oxytocin. CDSCO wants to adopt a barcoding system as part of its latest drive to curb the misuse of the drug by farmers.
Officials think barcoding oxytocin will support a track-and-trace system that prevents the drug being diverted for use in farming, where it is given to cows to increase milk production.
That is one of four proposals put forward by CDSCO to stop misuse. The other suggestions would ban the importation of oxytocin for both human and animal use, while also stopping organizations other than registered hospitals and clinics from sourcing the drug. The final proposal is to restrict production of the drug to public sector facilities.
CDSCO released the suggestions for a 15-day consultation period shortly after meeting with oxytocin manufacturers. The meeting and proposed restrictions were deemed necessary, as existing efforts to stop misuse have failed to eradicate the practice. CDSCO banned retail pharmacies from selling the drug in 2014 and ordered a regulatory crackdown last year but still receives reports of misuse.  
CDSCO Notice
India Asks Medical Device Testing Labs to Seek Designation
India has asked medical device testing labs to seek designation to support the introduction of rules covering the sector. The request is intended to establish a network of accredited testing laboratories capable of carrying out tasks mandated by the Medical Device Rules, 2017.
Acting Drug Controller General Dr. S Eswara Reddy wants organizations accredited by the National Accreditation Board for Testing and Calibration Laboratories to submit information about the devices they can test and the person who will oversee the work. CDSCO will assess the submissions before deciding which organizations to designate as central medical device testing laboratories.
These laboratories will test medical devices and in-vitro diagnostics and generate reports based on their findings. Regulators will use the reports to evaluate the performance of products destined for the Indian market.
DCGI Notice
TGA Recommends Pre-Submission Meetings for Some Complementary Medicines
The Therapeutic Goods Administration (TGA) has recommended developers of registered and assessed listed complementary medicines meet with it before filing for approval.
TGA has long advocated that developers of prescription medicines, two classes of biologicals and certain types of medical devices seek its input before making submissions. The list of types of products covered by the TGA recommendation reflects a belief that pre-submission meetings are most valuable to developers of complex and first-in-class products.
Now, TGA has added registered and assessed listed complementary medicines to the list of products for which pre-submission meetings are “highly recommended.” The change follows the reform of complementary medicine regulation by the agency. Those changes created a three-tier model of complementary medicine regulation. TGA recommends developers of medicines in the top two tiers request pre-submission meetings.
Aside from the contact for requesting a meeting, the pre-submission process for complementary medicines is the same as for other types of product. The sponsor is expected to prepare a briefing package and gets up to 90 minutes to discuss issues related to the planned submission.
TGA Guidance
Other News:
South Korea has introduced a drug management system. The Ministry of Food and Drug Safety (MFDS) outlined the model in a statement detailing how biopharma companies, wholesalers, pharmacies and other players in the drug supply chain can become members of the management system. Officials will clear organizations to join the program after assessing documents they submit. MFDS Notice (Korean)
CFDA has published documents relating to its plans to supervise the sales of medical devices. The texts cover the actions CFDA wants its regional offices to take and other details. CFDA Notice (Chinese)
TGA has shared the presentation it gave at stakeholder consultation sessions about proposed changes to good manufacturing practice fees. A consultation about the proposed revisions closed this week. TGA Presentation


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