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Asia Regulatory Roundup: China Targets Data Integrity In Checklist for Inspectors of Medical Device Trials

Posted 04 December 2018 | By Nick Paul Taylor 

Asia Regulatory Roundup: China Targets Data Integrity In Checklist for Inspectors of Medical Device Trials

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
 
TGA Creates Guidance to Help Surgical Mesh Manufacturers Reclassify Devices
 
Australia’s Therapeutic Goods Administration (TGA) has created guidance to help sponsors of surgical mesh devices manage a change in their regulatory status. TGA published the guidance days before reclassifying the devices as high-risk Class III products.
 
Surgical mesh devices have historically been categorized as medium-risk Class IIb devices in Australia. However, with the European Union voting to reclassify surgical mesh implants as high-risk products when it passed the new medical device regulations last year, Australia revealed a new approach 13 months ago. In keeping with its policy of aligning with the EU, Australia proposed reclassifying mesh devices as high-risk products but also chose to accelerate the move to the new regulatory status.
 
The upshot of Australia’s view of the urgency of the situation is that it reclassified mesh devices as Class III products on 1 December, around 18 months before the new EU rules come into force. TGA has published guidance to help sponsors of surgical mesh medical devices cope with the change.
 
From now on, all new applications for inclusion of surgical mesh implants in the Australian Register of Therapeutic Goods (ARTG) will treat the devices as Class III products. Sponsors with implants already in the ARTG have until 1 May to notify TGA about all their existing Class IIb mesh devices. Sponsors that fail to provide information about devices already in the ARTG will be forced to stop supplying their mesh products immediately.
 
Complying with TGA’s request will give sponsors time to ready Class III submissions. Sponsors of urogynecological devices and all other types of surgical mesh then have until December 2020 and 2021, respectively, to file Class III applications.
 
Other sections of the guidance cover conformity assessment documents, the requirements for Class III applications and what happens after TGA accepts or rejects a submission.
 
TGA Guidance
 
China Targets Data Integrity In Checklist for Inspectors of Medical Device Trials
 
China has released a checklist to guide on-site inspections of medical device clinical trials. The text tasks inspectors with ensuring the results generated in studies are consistent and traceable.
 
The National Medical Products Administration (NMPA) has broken the document up into two parts. The first section runs through all the points inspectors must assess when reviewing a trial, from the clearances the sponsor should have received through to how medical devices and the data gathered on them are handled. For each point, NMPA tells inspectors what documents and processes to check.
 
In the second part of the document, NMPA lists principles inspectors should consider when judging the results of their assessments. These principles advise inspectors to consider the authenticity of the materials they assess.
 
One principle addresses the traceability of clinical trial data. Others cover the consistency of data in the original clinical trial report and registration applications and the use of medical devices other than the stated experimental product.
 
Inspectors can deem a clinical trial to have a compliance problem because of authenticity problems, and because of failures to follow the processes covered by the checklist.
 
NMPA Checklist (Chinese)
 
India Proposes Tighter Rules on Blood Collection and Processing Operations
 
India is planning to strengthen the rules on blood collection and processing. The draft legislation would change the qualifications needed to run and work at blood centers.
 
In the draft, the Indian government proposes requiring blood centers to employ a full-time medical officer who has a degree in medicine and experience with working in the sector. The draft also changes the qualifications required by technicians and technical supervisors, and mandates the employment of a counselor or medical social worker who has a master’s degree in a field such as psychology.
 
The Indian government is using the revision to tweak its position on the processing of blood and its components, too. The revisions include a new section on the preparation of pooled platelet concentrate and revisions to the legislation on the use of cell separators to remove a particular component of blood. 
 
Other sections of the legislation cover the equipment blood centers should possess and the criteria they should use to judge the eligibility of someone to give blood. The criteria are a mix of objective measures, such as age and blood pressure, and more subjective assessments of wellbeing.
 
The government released the document for a 45-day consultation on 29 November. 
 
Gazette Notification
 
Pakistan Calls for Members of Islamic Bloc to Harmonize Regulatory Standards
 
The head of Pakistan’s regulator has called on members of the Organization of Islamic Cooperation (OIC) to harmonize their medicine and vaccine standards. Sheikh Akhter Hussain sees harmonization contributing to a broader effort to increase cooperation and drug self-reliance among OIC nations.
 
Hussain, the CEO of the Drug Regulatory Authority of Pakistan (DRAP), made the comments at the first meeting of the heads of national medicine authorities of OIC member states. OIC is a group of 57 countries that work cooperatively to ensure the progress and wellbeing of Muslims. That remit now covers cooperation on the regulation of medicines and vaccines.
 
OIC began increasing its focus on regulation this time last year when a report prioritized achieving self-reliance in the production and supply of medicines and vaccines. The goal is to ensure essential health products are available in all OIC countries, including those that currently lack the resources to meet the needs of their populations.
 
DRAP’s efforts in the area focus on improving its standing on the World Health Organization’s Global Benchmarking Tool through investments in the establishment of good practices and alignment with international standards. Hussain wants to see other OIC countries harmonize their standards.
 
DRAP Statement
 
TGA Clarifies Acceptable use of ISO 13485 Certificates in IVD Assessments
 
TGA has revised its guidance on the use of marketing authorization evidence from comparable overseas regulators. The latest version prohibits the use of certain ISO 13485 certificates in filings for approval of in-vitro diagnostics (IVD).
 
When version 1.0 of the guidance came into force in August, TGA listed ISO 13485 certificates among the evidence developers of Class II and III IVDs could use to demonstrate the acceptability of their quality management systems (QMS). In version 1.1, TGA has added a caveat to the use of the ISO QMS certificates.
 
The revised guidance states the ISO certificates are acceptable provided they are “issued by a certification body that is also a Notified Body designated under the IVDD 98/79/EC.” TGA will not accept certificates issued by a body “that is accredited by a signatory member of the International Accreditation Forum Multilateral Recognition Arrangement.”
 
TGA Guidance
 
Other News:
 
India’s Central Drugs Standard Control Organization (CDSCO) has introduced a Sugam module for uploading data on licensed drug formulations and their manufacturing facilities. CDSCO wants all drug manufacturers to prioritize the uploading of data to the online portal. To support the work, CDSCO has created a user manual that provides a step-by-step guide to the process. CDSCO Notice
 
TGA has published guidance on boxed warnings. The guidance outlines why a boxed warning may be added to product and consumer medication information documents, and shows sponsors how and when to use the safety feature. The publication of the guidance comes months after Gilead Sciences spoke out against TGA’s planned revisions to its position on boxed warnings. TGA Guidance

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