Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China Seeks Feedback on Plans for Drug Traceability and Unique Device Identifiers
The China National Drug Administration (CNDA) has posted draft guidance on the construction of IT systems capable of tracking drugs as they move through the supply chain. CNDA posted the guidance on the same day as it released a draft document setting out its position on unique device identifiers.
Both documents are intended to improve electronic tracking capabilities, albeit in different ways. The drug traceability guidance sets out how companies can implement systems expected to stop fake and substandard drugs from entering the legal supply chain, while also making it easier to recall products and investigate quality failings when something does go wrong.
Lots of details about the system still need to be worked out. The guidance provides a map for these next steps. CNDA has laid the groundwork with the publication of guidelines on the construction of the traceability system and its coding requirements.
However, issues including data security and the actual construction of the system need to be worked through by the time the traceability platform is due to be fully functioning in 2022. In light of the scale of the task, CNDA is proposing a phased transition to the system, with particularly important drugs being tracked and traced ahead of total coverage occuring in 2022.
CNDA expects industry associations to play a big role in the construction of the drug traceability system. The national regulator, provincial offices, manufacturers, retailers and other groups will also play roles in the design, construction, implementation and use of the system.
A separate draft guidance document on a unique device identification system is intended to move China toward a system that enables stronger, more efficient supervision of the development, manufacturing and use of medical technologies. CNDA released an earlier version of the draft for consultation in February.
CNDA is accepting feedback on the drug traceability draft until 20 September. The device identifier draft is open for comment until 21 September.
, Device Draft
TGA Revises Approach to GMP Clearance Extensions to Cope With Growing Workload
The Therapeutic Goods Administration (TGA) of Australia has started processing good manufacturing practice (GMP) clearance applications according to expiry dates. TGA changed its process in response to “the large volume of extension applications received.”
GMP clearance applications are a long-standing problem for TGA. The number of applications sent to TGA has increased by more than 100% since 2010. To compound matters, more than half of the GMP clearance filings TGA received historically were incomplete, forcing it to chase applicants for missing information. TGA responded by posting revised, more detailed guidance and taking a tougher line on incomplete submissions.
The agency made those changes in September. Seven months later, TGA followed up with a notice that highlighted some of the common submission errors companies were continuing to make.
Now, TGA has revealed the number of GMP clearance extension applications is continuing to cause it problems. The number of applications awaiting processing has persuaded TGA to change the order in which it handles applications. For now, TGA will arrange its backlog by expiry date and try to get to filings two to three weeks before the associated GMP clearance expires.
Taking this approach should ensure TGA processes extension applications before the GMP clearance expires. Ordering the applications by submission date would create a risk that TGA may fail to reach a filing before the clearance expires. TGA still wants companies to seek extensions as early as possible.
TGA’s admission that the volume of extension applications has forced changes to its workflow comes months after industry called for the agency to improve its services. The comments followed TGA’s proposed increases to GMP fees, including the payment for handling clearance applications. Industry group Medicines Australia argued the fee hike should be tied to commitments to improve services.
China Investigating Suspected Serious Violations by Former Drug Registration Director
China is probing suspected serious legal violations by the former director of drug registration and management. News of the investigation comes shortly after Chinese authorities dismissed several regulatory officials for their roles in the vaccine scandal.
Wang Lifeng, the drug registration director, was absent from the list of officials dismissed last week but left the agency at some point. CNDA revealed that in a brief statement that described Wang as the “former” director and outlined the investigation into his actions.
CNDA is yet to publicly discuss the focus of the probe, stating only that Wang is suspected of serious violations of the law and as such is the subject of a disciplinary review and surveillance investigation.
The investigation into Wang is contributing to a period of upheaval in the Chinese regulatory sector. Authorities dismissed five top regulatory officials and issued a warning to another last week. This week, the probe into Wang became public and China’s official news agency Xinhua
reported the Jilin provincial government had fired its food and drug safety chief and two deputy heads.
TGA Stops Pre-evaluation of Herbal Component Names to Cut Red Tape
TGA has stopped pre-evaluating herbal component names (HCNs). The Australian regulator used to make sponsors apply to have HCNs evaluated and approved, but the process created problems for it and the industry.
HCNs are “standardized components comprising either a single chemical constituent or a particular group of chemical constituents found in herbal ingredients.” The terms can be used on product labels in some situations, such as when names are needed to identify marker components of standardized herbal ingredients or claims are made about the strength of herbal ingredient components.
New HCNs were pre-evaluated, but the merits of the practice have been questioned. The requirement is out of step with the approach to listed medicines in general, which come to market without going through pre-evaluation. Equally, there are concerns the practice is a bad use of TGA resources and industry has complained about the length of the process,
In response, the agency proposed ending the requirement in October. The proposal outlined the case against the pre-evaluation process and asked people whether they wanted to keep the status quo or have TGA work with the industry to discontinue the practice.
Four of the seven respondents to the consultation called for TGA to end the pre-evaluation process. Two respondents voted for the continuation of the status quo, and one expressed no opinion on the question.
With the majority of respondents backing discontinuation, TGA has ended the need for companies to seek pre-evaluation with immediate effect. On 1 October, TGA will also stop allowing sponsors to choose HCNs from a list of approved names for use in new listings. Instead, TGA will permit sponsors to make claims about herbal components on their labels provided “they are true and comply with regulatory requirements.” Sponsors are expected to have evidence to support claims.
TGA may ask to see this evidence, but as part of a post-market compliance review, not a pre-market evaluation. The shift brings TGA’s approach to HCNs in line with its stance on listed medicines. TGA said the change “will remove unnecessary regulatory red tape for sponsors” and free it from a task that “is resource intensive and is not cost recovered.”
, Consultation Responses