Asia-Pacific Roundup: Quality concerns drive TGA face mask review

RoundupsRoundups | 17 November 2020 |  By 

Australia’s Therapeutic Goods Administration (TGA) has begun a postmarket review of face masks amid concerns some do not perform as intended or meet the requirements for inclusion in the Australian Register of Therapeutic Goods (ARTG).
The review will assess if face masks in the ARTG, including devices in the National Medical Stockpile, meet the regulatory requirements and perform as intended. TGA is assessing compliance with the standards for Exhalation Resistance, Inhalation Resistance and Particulate Filtration Efficiency using third-party laboratories.
TGA is asking suppliers to ensure they meet the requirements and to confirm they have materials the agency will need to perform its review, including conformity assessment certificates, details of manufacturing standards and a copy of the labeling.
TGA has already taken action against one company. The agency’s discovery of “systemic failures in quality control measures, an absence of batch numbers and inconsistent testing results” led supplier M House to issue a Product Defect Alert. Many of the masks passed the test but variability of fluid resistance performance and inability to trace batch numbers led TGA to act.
TGA does not plan to recall masks identified as noncompliant due to the “current COVID-19 situation around Australia.” Rather, TGA plans to advise users of masks of the issues and clarify the settings in which the devices are suitable for use. In the case of M House, that meant asking users to only wear the masks in high-risk settings if there are no alternatives. TGA wants healthcare professionals to wear a face shield in addition to the mask in those settings.
M House last imported masks into Australia in July and has no plans to supply more products. TGA is awaiting more information from M House before deciding if additional actions are needed. 
TGA Notice, More
China details plans to strengthen stent oversight after securing price cuts
China’s National Medical Products Administration (NMPA) has called for provincial drug regulatory authorities to strengthen oversight of the coronary stent supply chain following news of centralized purchasing agreements for the medical devices.
Earlier this month, Chinese authorities estimated the application of their centralized procurement program to coronary stents will lower stent prices by 90%,  based on agreements on 10 stents with Boston Scientific, Medtronic and six Chinese companies. China is set to buy more than 1 million stents a year through the procurement program, starting in January.
With the deal positioning the eight companies to treat more patients, NMPA wants to ensure their devices comply with regulations. NMPA is asking regional regulatory authorities to perform on-site inspections of any of the eight companies with plants in their jurisdictions by the end of 2020.
NMPA also wants regulators to inspect the companies at least once a year. NMPA picked out staff training, raw material procurement, adherence to sterilization practices and the implementation of finished product inspection to focus on.
The agency also wants regulators to assess the quality of sampled coronary stents, using the results to inform their inspection priorities, and ensure the transportation and storage of the devices is compliant with the requirements. Adverse event monitoring is another part of the plan.
NMPA is asking stent manufacturers to improve quality management systems and other aspects of their operations. The agency highlighted strict control of raw materials and management of suppliers and improved management of production processes as areas it wants to see companies act.
NMPA Notice (Chinese)
Singapore seeks feedback on cell and gene therapy regulation
Singapore’s Health Sciences Authority (HSA) has begun a consultation about cell, tissue and gene therapy products (CTGTP), with the aim of revising legislation to define CTGTP while supporting R&D and patient access.
The consultation floats a risk-based classification of CTGTP. HSA plans to treat CTGTP as lower risk if a product is minimally manipulated, intended for homologous use and not used in combination with therapeutic products or medical devices. CTGTP that do not satisfy all those criteria fall into Class 2, the higher risk group.
HSA plans to exempt manufacturers of Class 1 products from the need to obtain dealers’ licenses. The manufacturers will only need to notify HSA of their activities and comply with good tissue practices. A similar approach applies to wholesalers and importers of Class 1 CTGTP.
Manufacturers of Class 2 products will need to undergo a HSA pre-approval audit that will assess their compliance with the CTGTP Good Manufacturing Practice Standard to get a license. Importers and wholesalers need to comply with good distribution practices. The risk groups will also shape HSA’s approach to clinical trials and product registration.
The consultation is open until 27 November.
HSA Notice
TGA to start transition to eCTD-only submissions
TGA has set out the schedule for the transition to exclusive use of the electronic Common Technical Document (eCTD) for all prescription medicines. The staggered transition is set to start in November 2021.
Starting on 1 November 2021, submissions for new chemical, biological, biosimilar and combination medicines will need to use the eCTD format. The format will then become mandatory for extensions of indications, major variations and new generic products on 1 June 2022. The staggered transition is due to end on 1 November 2022.
Most applications covered by the first two deadlines are already submitted using the eCTD format, according to TGA. The transition timeline established by TGA is intended to ensure the progress of new drugs is unaffected by the eCTD requirement. TGA will assess requests for exemption from the requirement from sponsors that cannot use the eCTD format on a case-by-case basis.
In preparation for the change, TGA plans to provide guidance, training and education. In doing so, TGA is aiming to ease the transition to a format it expects to enhance lifecycle management and provide benefits to sponsors and regulators alike.
Once a sponsor starts using eCTD it must stick with the format for all future submissions.
TGA Notice
NMPA seeks feedback on measures for managing online medicine sales
NMPA has released draft guidance on the supervision of online medicine sales for consultation. The guidance prohibits the sale of certain products including vaccines online while providing a framework for how prescription drugs can be traded via the internet.
In the draft, NMPA makes online retailers responsible for ensuring the electronic prescriptions shared by customers are authentic. Online retailers are also responsible for establishing safety management and distribution management systems. Other sections of the guidance cover reporting requirements, record keeping and responsibility for recalling medicines subject to safety or quality concerns.  
The draft is open for comment until the end of the month.
NMPA Notice (Chinese)
Other News:
The Drug Regulatory Authority of Pakistan (DRAP) has imposed measures to curb the spread of the coronavirus. Acting in response to direction from the Pakistani government, DRAP has barred people from pharmaceutical companies from visiting its offices. DRAP is asking staff to wear masks and only hold meetings in its offices if absolutely necessary. DRAP Circular, More


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