Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China Reports Sharp Increase in Applications to Drug Review Center
China’s Center for Drug Evaluation (CDE) has reported a sharp increase in the number of applications it receives. In 2018, CDE received 5,574 applications for technical review, an increase of 47% over the previous year.
The increase is one of many double-digit rises detailed in CDE’s 2018 drug evaluation report. The number of Chinese medicines, chemical drugs and biological products submitted for registration rose by 30%, 50% and 42% respectively. CDE also recorded a 43% increase in the number of new drug applications. The number of abbreviated new drug applications increased faster still.
CDE has managed to reduce its backlog despite the increased workload. In September 2015, almost 22,000 registration applications were awaiting review and approval by CDE. By the end of 2018, CDE had brought the number down to 3,440.
The reduction follows a period in which China took actions to reduce its backlog, notably by asking applicants to self-audit their data and withdraw their filings if they discovered any discrepancies or problems.
Industry Group Pushes Back Against TGA GCP Inspection Proposal
Medicines Australia has pushed back against plans to start a good clinical practice (GCP) inspection program. The Therapeutic Goods Administration (TGA) thinks the program will make Australia a more attractive location for clinical research, but the big pharma trade group fears it will have the opposite effect.
Currently, the approving Human Research Ethics Committee assesses and green lights clinical trials. TGA has praised the speed, cost and access benefits of this system but also thinks it has downsides. As TGA has less oversight over GCP compliance than its regulatory peers, the agency is concerned that international recognition of the quality and integrity of clinical trial data generated in Australia could decline over time, resulting in fewer sponsors wanting to conduct studies in the country. TGA wants to mitigate that risk by establishing a domestic regulatory GCP inspections program.
The proposal received a mixed reception from the drug industry when TGA shared it for consultation earlier this year. While industry respondents were broadly supportive of the planned implementation of a GCP pilot program, they raised significant concerns with the rationale and approach detailed by TGA.
Medicines Australia is particularly concerned about TGA’s plans to use results generated in the GCP inspection program to attract more clinical research. To start, Medicines Australia questioned why TGA “seems to imply global perceptions of site quality is currently an issue.” Medicines Australia is unsure what data supports that position. Worse still, Medicines Australia fears the GCP inspection program may generate data that wrongly suggests site quality is a problem in Australia.
“If the TGA program uses a targeting approach based on risk (e.g. more complex studies, more high-risk therapies, higher risk sites or sponsors, especially non-commercial sponsors), the results from the TGA program are likely to be worse than FDA or EMA programs,” Medicines Australia wrote. “The results produced could therefore ... make Australia’s GCP quality look worse than comparable countries.”
That concern is one of several raised by Medicines Australia. The trade group said the idea that the GCP inspection program will encourage compliance is “flawed,” noting that global commercial trial sponsors are already strongly incentivized to run high-quality trials as missteps can result in delays or rejections of new drug filings.
Medicines Australia also questioned whether the initiative will meet its stated goal of giving local sponsors and investigators “greater confidence that their trials are conducted in a manner that meets international requirements.” For that to happen, Medicines Australia thinks the program will need an “extensive strategy” for disseminating findings. Medicines Australia thinks that could be achieved by feeding findings into the National Clinical Trials Governance Framework project.
TGA responded briefly to some of the common points made by the 37 respondents to the proposal. In its response, TGA noted that six respondents questioned the rationale for the program, typically because they felt the focus should be on protecting clinical trial participants and data credibility, not the global competitiveness of Australia. TGA said that safeguarding public health is the primary goal, adding that it will flesh out its rationale for the program in upcoming guidance documents.
, TGA Response
India Delays Deadline for Submitting Data on Disputed FDCs
India’s Central Drugs Standard Control Organization (CDSCO) has given manufacturers of fixed-dose combinations (FDCs) more time to submit information about their products.
In May, a subcommittee of the Drugs Technical Advisory Board gave the manufacturers of around 300 potentially irrational FDCs until the end of June to submit information including one-page summaries of evidence to support claims of rationality.
Since then, affected manufacturers have asked CDSCO to give them more time to prepare and file the requested information. CDSCO granted the request this week, pushing back the date by which FDC manufacturers must submit the information to 16 August.
Philippine FDA Issues Warnings About Counterfeit GSK Products
The Philippine Food and Drug Administration (FDA) has issued warnings about fake versions of two GlaxoSmithKline products. FDA noted that counterfeit copies of GSK’s rabies vaccine Rabipur and antibacterial combination Augmentin are circulating in the country.
GSK and FDA have worked together to verify that the products are counterfeit, leading to a notice disclosing the problem and discussing the differences between the fake and real products. There are two counterfeit versions of Rabipur on the market, both of which differ from the genuine vaccines in ways including the darkness of the ink used.
FDA is advising healthcare professionals and other people who may handle the products to be aware of the presence of counterfeits in the supply chain that could harm consumers. Similarly, FDA told consumers to only source products from licensed establishments.
, Augmentin Warning
China Stops Accepting old Word Files After Formatting Problems Delay Reviews
China’s CDE has stopped accepting applications filed in the older .doc Word file format. CDE took the action in response to formatting problems created by the file type and the wasted review time they cause.
Microsoft introduced a new version of its Word software that uses an open file format, carrying the suffix .docx, in 2007. However, not all applicants prepare documents in modern versions of Microsoft Word, resulting in CDE continuing to receive submissions that use the older file format.
That has created problems for CDE. Formatting issues and the garbling of text are stopping CDE from quickly reviewing applications. CDE also thinks the older document type carries some security risks.
To remedy the situation, CDE has stopped accepting applications in .doc files.
’s Health Sciences Authority
(HSA) has issued a warning about four skin creams after one of the products was linked to the hospitalization of an infant. The infant developed Cushing’s syndrome after being treated for diaper rash. The skin creams were found to contain undeclared ingredients including steroids, antibiotics and antifungals. HSA Notice
is seeking feedback on scored generic tablets. The document is intended to provide technical advice on developing such tablets, which are designed to be split in half, and making postapproval changes to them. CDE is accepting feedback on the draft until 2 August. CDE Notice
’s Therapeutic Goods Advertising Consultative Committee has provided an update on its activities. TGA Notice