Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Creates Guidance on Device Standards for Quality Management Systems
The Therapeutic Goods Administration (TGA) has created guidance to help companies comply with a medical device law passed in Australia earlier this year. The law covers medical device standards for quality management systems (QMS) and medical devices intended to be supplied in a sterile state.
Conformity assessment procedures require medical device manufacturers to implement a QMS for the design, production, packaging, labeling and final inspection of a device, and apply inspection and quality assurance techniques during the production of a device. Legislation passed in Australia earlier this year details the conformity assessment standards for medical device QMS in general and for systems that support products supplied in sterile states.
TGA explained the significance of the legislative order in its guidance.
“The Order ensures that if a manufacturer's QMS, or inspection and quality assurance techniques, comply with the relevant standards specified in the Order, the TGA will treat the QMS, or the inspection and quality assurance techniques, as if they comply with the parts of the conformity assessment procedures specified in the Order,” TGA wrote.
As TGA explains in its guide, the standards with which medical device manufacturers should comply include ISO texts about QMS and the sterilization and aseptic processing of healthcare products. The guidance clarifies that manufacturers can comply with either the original ISO standards or identical requirements adopted by individual countries.
For example, a company can show its QMS meets the required standard by achieving compliance against either ISO13485:2016 or the equivalent texts in Australia, Europe and the United States.
, Australian Legislation
China Seeks Feedback on Choosing Endpoints in Lung Cancer Clinical Trials
China’s Center for Drug Evaluation (CDE) has published draft guidance on the selection of endpoints in trials of non-small cell lung cancer (NSCLC) drugs. The document discusses overall survival and the scope to use other endpoints that shorten the time to market for breakthrough NSCLC medicines.
Lung cancer, most cases of which take the non-small cell form, has been the leading cause of cancer deaths in China for years, despite the high prevalence of epidermal growth factor receptor mutations in the country making it an early proving ground for targeted EGFR tyrosine kinase inhibitors. Many patients, even in China, lack EGFR mutations, and there is scope to improve outcomes in people who harbor the genetic feature.
To support efforts to develop new NSCLC drugs, CDE has created a guideline that documents the types of endpoints that may be used in clinical trials and other design considerations. The guideline reflects acceptance that, while randomized controlled trials with overall survival endpoints generate the most robust evidence, the need to get drugs to market quickly means alternative methods are needed.
In the text, CDE sets out the strengths and weaknesses of overall survival, progression-free survival and objective response rate as endpoints in NSCLC trials. The explanation covers how to design trials around the endpoints and the potential to use data they generate in filings for full and conditional regulatory approvals.
Other sections of the guidance address the selection of patient populations with certain biomarkers, the choice of comparator and the use of data from single-arm trials in filings for approval. The guide encourages sponsors to discuss the exploration of novel trial designs and endpoints with regulators.
CDE is accepting feedback on the draft for one month. The feedback will inform the finalization of this version of the document, but CDE expects to change the text as the treatment of NSCLC evolves.
China Posts Guide to Collecting Clinical Safety Data From Research Literature
China’s National Medical Products Administration (NMPA) has published a guide to using research literature as a source of clinical safety data. NMPA thinks the guidance will help companies fulfill their drug safety responsibilities for approved products.
The guidance refers to the systematic and comprehensive collection of data from relevant research literature as one of the main ways products are assessed after they win approval. To help companies source the information needed to maximize the effectiveness of the practice, the guidance provides step-by-step instructions detailing how to evaluate the literature.
NMPA advises companies to start by determining the purpose of the evaluation and developing a research plan. These actions will inform the search for data and screening of the literature. NMPA is encouraging companies to extend their searches beyond the peer-reviewed literature to take in texts such as conference papers, unpublished dissertations, industry reports and consulting publications, as excluding these sources may introduce bias into the dataset.
When companies analyze and discuss the findings of their literature searches, NMPA wants them to detail how they controlled for bias and the limitations of their efforts. The discussion should also cover the significance of the key findings of the literature search and how they compare to results from similar studies.
has alerted companies to an International Medical Device Regulators Forum
(IMDRF) consultation on regulatory pathways for personalized medical devices. IMDRF is trying to establish a harmonized approach to the application of existing regulatory pathways to personalized medical devices and is accepting feedback on proposed guidance until 24 July. TGA Notice
Drug regulatory authorities from China
have met to discuss strengthening cooperation. The talks took place against a backdrop of concern in India about its reliance on Chinese ingredients and the difficulties its manufacturers face when trying to gain clearance to sell products in China. NMPA Notice
has published information for consumers on the use of “natural” and related terms in materials about medicines and medical devices. The publication comes shortly after TGA established guidance for industry on the use of the terms. TGA’s consumer-focused release explains what makes a product natural and states that treatments promoted as being natural are not necessarily safe. TGA Notice