Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
CFDA Clinical Data Probe Triggers Investigations Into 11 Trial Sites, CROs
China’s Food and Drug Administration (CFDA) has opened investigations into 11 clinical trial sites and contract research organizations (CROs) as part of a data verification drive initiated last year. The regulator suspects the sites and CROs generated fraudulent clinical trial data to support 27 new drug applications.
CFDA released details of the investigations as part of a breakdown of the numbers associated with the self-audit of drug applications by organizations seeking approval in China. Of the 1,622 applicants asked to carry out the self-examination in July 2015, 1,193 organizations withdrew their submissions voluntarily after receiving the regulator’s request. CFDA allowed applicants to withdraw their filings without facing punishment. As 193 of the applicants were exempt from clinical trials, the withdrawals amount to 83% of all the submissions that went through the self-audit.
The regulator is seeking to dispel reports all of the applications were withdrawn because their data were fraudulent. While CFDA acknowledges some of the applications included false data, deliberately or by mistake, others were withdrawn because of more prosaic failings. Some of the withdrawals were triggered by recognition of failures to comply with good clinical practices (GCPs). Others were a result of the clinical trial data falling short of what is needed to demonstrate the safety and efficacy of a medicine.
That organizations thought such flawed filings were sufficient to win approval reflects poorly on CFDA and its practices in the run up to the self-audit, while also raising questions about the quality of drugs approved prior to the raising of regulatory standards. The numbers also suggest fraudulent data are a significant problem. While the proportion of companies that withdraw filings because they knew the data were suspect is unknown, CFDA has shared details of its reviews of applications that survived the self-audit process.
CFDA had verified 117 applications as of the end of September. The regulator rejected 30 of these on the grounds of authenticity defects. CFDA notes this equates to approximately 2% of all the applications that underwent self-examination. However, it is also 25% of all the applications the regulator had verified at the time the numbers were compiled.
CFDA Report (Chinese), Xinhua
Indian Medical Device Rules Take Another Step Toward Adoption
The Indian government has published the latest version of its draft medical device rules in its journal of official notices. Publication of the draft in the Gazette of India moves the government a step closer to separating the laws covering drugs and medical devices.
Officials signaled their intent to establish separate laws for medical devices in June. Days later, the Central Drugs Standard Control Organization (CDSCO) published a first draft of the regulations. That document defined and categorized medical devices, detailed the responsibilities of firms involved in the sale and production of different types of products and outlined the regulatory infrastructure that will oversee the industry. Since then, the draft has been changed in light of feedback from industry, resulting in the version that was published in the Gazette this week.
Large sections of the text are unchanged, or only lightly edited. CDSCO has revised its definition of medical devices to clarify the status of accessories. In the regulations, an accessory is defined as “an article that is intended specifically by the manufacturer to enable a medical device to be used in accordance with its intended use.” The original draft stated accessories “are classified in their own right separately from the device with which they are used,” but did not give such products equal billing with instruments and implants in its definition.
CDSCO has also removed some lines from the original draft. The text published earlier this year said bodies tasked by the government with auditing device manufacturing sites must do so “subject to the supervision by the State Licensing Authority.” CDSCO has removed the reference to supervision from the current draft. The latest test also frees bodies registered to perform audits from the need to renew their licenses. In keeping with CDSCO changes to other types of licenses, the registrations will now last indefinitely. The earlier draft stated the registrations would expire after three years.
The Ministry of Health is currently accepting objections and suggestions regarding the latest draft.
CFDA Starts Consultation on Quality Control for Certain Biologics
CFDA has begun a consultation on good manufacturing practices (GMPs) for certain biologic drugs. The document details the characteristics of quality control management systems manufacturers must implement to ensure the safety and efficacy of medicines derived from raw materials such as organs and body fluids.
Manufacturers of such products face some specific quality control challenges that are addressed by CFDA in its draft GMP guidance. CFDA wants manufacturers to pay particular attention to the origin and quality of raw materials. Manufacturers need to establish effective traceability systems and get their suppliers to sign quality assurance agreements. Suppliers must adhere to the guidelines set out in the GMP document and be willing to accept regulatory inspections. Raw materials must come from healthy animals raised in areas free from pests.
The guidance also places responsibilities on manufacturers. CFDA wants drugmakers to adopt virus removal and inactivation methods that are appropriate for their raw materials. These measures must ensure the finished drug is free from potentially harmful viruses without otherwise affecting quality. If a manufacturer wants to change its production process, it must reassess and, potentially, re-verify the effectiveness of the measures used to remove and inactivate viruses. CFDA uses the guidance to state that these precautions are intended to complement, not replace, oversight of raw materials.
Multiple other elements of effective quality control systems are discussed in the draft. CFDA wants manufacturers to ensure all staff engaged in production, quality assurance and control and sourcing are trained in the hygiene and safety aspects of their roles. The regulator also dictates the experience certain members of the team need to fulfill their duties. Individuals in charge of quality control and production management must have professional experience in a field such as microbiology. Similarly, members of the supplier audit team need to know about the feeding and slaughter of animals.
CFDA is accepting feedback on the draft until 12 November.
CFDA Notice (Chinese)
TGA Alerts Biologics Manufacturers to Billing Issue
The Therapeutic Goods Administration (TGA) of Australia has told manufacturers of biologics about an issue with its online billing system.
In response to the discovery of the fault, TGA is asking applicants for biologics-only manufacturing licenses to file as usual using the online system but stop before providing payment. Rather than use the online payment system, TGA wants companies to email their details. Once TGA has the details, it will provide a new invoice that lists the correct fee. After TGA receives the requested amount, it will process the application.
The revised process only applies to applications for biologics manufacturing licenses. Fees for licenses covering the manufacture of medicines, blood and blood components, as well as those relating to inspections, should be paid using the online platform.
has published an alert regarding the JMS infusion set
. The product has an approved shelf life of three years. However, the manufacturer has imported batches with a stated shelf life of 61 months. Device Alert