Asia Regulatory Roundup: China Adds 30 Drugs to Fast Track for Products Approved Overseas

Regulatory NewsRegulatory News | 10 April 2019 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Reports Jump in Timely Completions of Overseas GMP Inspections
Australia’s Therapeutic Goods Administration (TGA) has improved the on-time rate of its overseas inspection operation. TGA performed 78% of inspections on time over the second half of last year, up from 53% over the corresponding period of 2017.
The agency aims to perform initial good manufacturing practice (GMP) certification inspections of overseas facilities within six months of receiving applications. However, TGA has struggled to achieve that target. Over the second half of 2017, TGA hit the target 53% of the time. TGA fared little better with certification re-inspections, completing 60% of those visits within the allotted time.
Now, TGA has revealed a sharp increase in the proportion of on-time initial inspections. The rate rose 15 percentage points from year to year, although there remains ample scope to improve on the 78% rate of on-time visits achieved in the second half of 2018. One potential explanation for TGA’s improved performance is a reduction in the number of inspections conducted by the agency, which fell from 49 in the second half of 2017 to 39 over the back half of last year.
Other aspects of TGA’s performance went in the opposite direction. The proportion of re-inspections performed within the six-month target window fell from 60% in the back half of 2017 to 52% over the corresponding period of last year.
Smaller swings were seen in the figures for inspections of Australian manufacturers. The on-time rate for initial inspections slipped slightly from 92% to 88%, while the proportion of re-inspections done in the six-month window rose from 68% to 78%.
TGA shared the data as part of its half-yearly performance report. The report covers the processing and approval times for all the activities performed by TGA, from prescription medicine authorization applications to the reporting of drug shortages. That scope means the report covers some areas that are relatively new parts of TGA’s remit.
Recent additions to TGA reporting include advertising complaints. As revealed earlier in the year, TGA generated 1,039 cases for action over the first six months in which it handled advertising complaints.
The half-yearly report features details of how quickly TGA processed these reports. TGA missed its time to action targets for both low and medium-risk cases. TGA hit its 14-day target for low-risk cases 90% of the time, as compared to a target of 95%. The underperformance was even more pronounced in the medium-risk cases. TGA acted on 74% of medium-risk cases in 40 days, well short of its goal of 95%.
TGA’s inability to hit its targets may reflect a disconnect between its forecasts of the workload and how many cases it has received in practice. In the first three months after taking over advertising, TGA received “a very high volume of complaints,” the Therapeutic Goods Advertising Consultative Committee said in October. TGA subsequently began expanding its advertising team.
TGA Report
China Adds 30 Drugs to Fast Track for Products Approved Overseas
China has opened up its fast track for urgent needs to another 30 medicines. The action builds on the decision to provide a streamlined path to market for 48 drugs already approved overseas last year.
Officials created the original list last summer to encourage drug developers to bring certain products that address major unmet needs to market in China. China subsequently approved drugs on the list, such as Alexion Pharmaceuticals’ rare disease blockbuster Soliris, and created guidance to help the targeted companies win approval on the strength of data on racial and ethnic differences.
The second batch of drugs destined to benefit from the fast track features fewer cancer drugs than the original list. While oncology drugs accounted for around 25% of the first list, the cancer section of the second batch features just Bristol-Myers Squibb’s Lysodren and Johnson & Johnson’s Erleada.
Rare disease drugs feature heavily on both lists. Some of the new orphan drug additions, such as Kyowa Kirin’s Crysvita, only won approval anywhere in the world shortly before China created its first list. That does not explain why other drugs were absent from the first list, though. Genzyme won approval for Fabrazyme in 2001, but China only added the drug to the fast track in the second batch.
Other products on the second list include Sanofi’s PCSK9 drug Praluent and atopic dermatitis treatment Dupixent.
CDE Notice (Chinese)
Korean Agency Probes Approved Gene Therapy Following Cell Line Error
The Korean Ministry of Food and Drug Safety (MFDS) has asked Kolon Life Science to stop making and selling its pioneering degenerative arthritis treatment gene therapy. MFDS made the request after learning that Kolon was using a different cell line than the one covered by its approval.
Kolon won approval for Invossa in South Korea in 2017, marking the first time a gene therapy had come to market in the country. Since then, Kolon and its partners have stepped up efforts to bring the product to market in the United States and other territories, but they have now hit a roadblock that is slowing commercialization and development.
The production of Invossa entails using a solution featuring TGF-β1 gene-insertion homologous chondrocytes to support the growth of cartilage cells found in another solution. However, kidney cells have entered the mix owing to separation and purification failings.
Kolon responded to the discovery of the rogue cells by voluntarily suspending sales of Invossa in Korea and halting the US Phase III trial program. All parties are now waiting on the results of a cell analysis that is due next week. Those results will inform how MFDS and other regulatory agencies handle the gene therapy.
Press Release (Korean), Business Korea, Korea Biomedical Review
CDSCO Calls Meeting to Discuss new Veterinary Medicine Rules
The Central Drugs Standard Control Organization (CDSCO) has called a meeting to discuss regulation of veterinary medicines. The meeting will support efforts to establish new rules for veterinary drugs, biologics and diagnostics in India.
CDSCO signaled its intention to pay more attention to veterinary medicine last year when it created a unit focused on the field. That action gave dedicated CDSCO staff oversight of regulatory activities related to veterinary medicine, including marketing authorizations, imports and field trials of drugs and vaccines.
Now, CDSCO is “in the process of framing new rules” for the sector that it hopes will “streamline the process of approval.” The agency is yet to disclose details of how it plans to achieve that goal but has called a range of trade groups and other organizations involved in veterinary care to a meeting later this month to discuss the matter.
CDSCO Notice
Other News:
TGA has released the feedback it received on its fees and charges proposal for 2019 to 2020. The agency received broadly positive feedback, with organizations including AusBiotech agreeing with its plan to increase all fees and charges by the indexation factor. Some groups used the consultation to press TGA to reduce red tape and otherwise eliminate unwanted costs and burdens. TGA Notice
Australia is set to make AU$331 million ($235 million) available for new and amended listings on the Pharmaceutical Benefits Scheme (PBS). The changes to PBS proposed in the 2019-2020 budget are intended to increase access to drugs to treat lung, bladder, kidney and skin cancer. Budget Proposal


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