Asia-Pacific Roundup: India releases a trio of IVD guidances for consultation

RoundupsRoundups | 12 July 2022 |  By 

India’s Central Drugs Standard Control Organization (CDSCO) has released three draft guidance documents that will reshape how manufacturers of in vitro diagnostics (IVDs) approach performance evaluation, postmarket surveillance and stability studies.
The draft texts, which are open for comment, build on the Medical Devices Rules (MDR), 2017, which came into force at the start of 2018 and regulate the manufacture, import, sale and distribution of notified medical devices and IVDs. CDSCO now has gone deeper into specific aspects of the regulation in these three draft documents.
Performance Evaluation: The performance evaluation draft describes the mandatory conditions at laboratories that assess IVDs, such as the use of air conditioning to maintain the accuracy and functioning of instruments, and outlines their responsibilities. CDSCO expects the sites to maintain records of tests for evaluation and performance for two years beyond the expiry date of the substance, or for six years if there is no expiry date.
Other sections cover the procedures for the dispatch, receipt, storage and testing of samples. For a site to accept a sample, the manufacturer needs to meet certain requirements, such as the use of adequate packaging and the inclusion of certain documents set out in an annex to the draft guidance.
CDSCO expects laboratories to test samples within 20 working days of receipt and retain them for up to one year after the date of expiry. Laboratories should calculate their fees to “cover the expenses subject to market conditions.” CDSCO is advising the sites “not to operate in a profit-oriented manner.”
Postmarket surveillance: Guidance on postmarket surveillance guidance is intended to strengthen the reporting of adverse events attributable to Class C and D IVDs and point-of-care tests or home-use IVDs. Class B IVDs are excluded because they are intended to “provide preliminary test results which require further confirmation by supplemental or confirmatory tests,” CDSCO said, and as such are not the sole determinants of diagnosis.
The draft states vigilance reporting for IVDs may be more difficult than for other products because harm is likely to be indirect. IVDs are unlikely to cause side effects but misdiagnoses could cause physicians to act or not act in ways that harm patients. CDSCO expects manufacturers, importers and distributors to identify events that have or could result in indirect harm or have led to death or serious deterioration of the health of the patient.
Reactive and proactive surveillance are part of the approach advocated for by CDSCO. For the proactive part of the strategy, CDSCO expects manufacturers to perform lot verification testing, monitor the literature for reports about their products and similar devices, and seek feedback from customers.
Stability studies: This draft aims to help manufacturers prepare scientific information to support the claimed shelf life of their IVDs. The guidance is intended to “support convergence of regulatory systems for medical devices among jurisdictions.” CDSCO is looking to adopt the guidance for premarket license applications and postapproval change applications and is “strongly” encouraging manufacturers to follow the text when submitting filings for Class C and D IVDs.
The document sets out the MDR requirements, as well as instructions for running, for claimed shelf life, in-use stability, shipping stability and other considerations, before outlining basic principles for stability testing using examples such as hepatitis C assays.
CDSCO also has used the guidance to establish its position on stability protocols and reports. The section on stability protocols describes how to prepare the testing plan, deploy statistical methods, read results and set the testing schedule. Once testing is completed, CDSCO expects companies to summarize the findings in a stability testing report that clearly identifies the objectives, conditions and conclusions of the study.
Performance Evaluation, Postmarket Surveillance, Stability Studies
TGA responds to recommendations for reform of cell, gene and tissue regulations
Australia’s Therapeutic Goods Administration (TGA) has responded to the recommendations made in a review of the regulatory framework for gene, cell and tissue therapies. The review looks set to trigger changes to clinical trial pathways and guidance on good manufacturing practices (GMPs).
TGA commissioned MTP Connect to conduct a stakeholder review of the regulatory framework last year. The resulting document identified a need for TGA to communicate more proactively in simpler language, align with comparable overseas regulators, improve the clinical trial approval (CTA) process and give gene, cell and tissue therapies access to orphan drug and priority review pathways.
The agency responded to each of the key topics. Some of the feedback has triggered actions at TGA. The agency is set to review the CTA process “including the need for an education campaign to raise awareness and clarity of the timeframes and process” in light of the feedback. Similarly, TGA plans to look into how to engage companies in early-stage development, although it said the request for capacity building for clinical trial centers is beyond the scope of its role.
Other upcoming changes include increased guidance on GMP requirements at various stages of cell and tissue therapy development. The changes reflect feedback that the current guidance is “unclear and how it was applicable across multiple stages (all phases of clinical trials, commercial, and manufacturing).”
TGA also vowed to continue investigating “options to align GMP requirements with those in the EU PIC/S GMP Guidance.” Finally, on the GMP side, the agency outlined how its digital transformation project will support applicants “in the collaborative evaluation of products and in advising applicants of the stage of different evaluation processes.”
TGA Response
Pfizer secures TGA provisional determinations for omicron-specific COVID vaccines
TGA has granted provisional determination to two omicron-specific COVID-19 vaccines in development at Pfizer. The provisional determinations cover monovalent and bivalent successors to Comirnaty.
Last month, Pfizer released results from a Phase 2/3 clinical trial that tested two booster doses of its omicron-specific vaccines. The monovalent vaccine achieved “super” superiority over the current version of Comirnaty, as per the US Food and Drug Administration’s guidance on COVID-19 vaccines. The bivalent vaccine, which features mRNA encoding for ancestral and omicron proteins, performed worse.
Securing the provisional determinations positions Pfizer to apply for provisional registration of the two vaccine candidates. TGA granted Pfizer provisional determination in light of the company’s plan to file “comprehensive clinical data and the seriousness of the COVID-19 pandemic.” Pfizer has six months to file its application, at which point TGA will review the evidence and reach a decision.
TGA Notice
Other news:
CDSCO has clarified the rules on medical device quality certificates after identifying “a source of confusion.” The problem relates to entities issuing quality certificates “to the manufacturers at their own level.” In light of the resulting confusion, CDSCO has clarified that quality certificates issued by other entities are not a replacement for licenses granted under the Medical Devices Rules, 2017 by the competent licensing authority. CDSCO issued the clarification ahead of all non-notified Class A and B devices entering the licensing regime at the start of October. CDSCO Notice


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