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Regulatory News | 25 April 2017 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Australia’s Therapeutic Goods Administration (TGA) has scrapped its 15-day target timeframe for processing good manufacturing practice (GMP) clearance filings. The target is a long-standing part of TGA’s guidelines for overseas manufacturers, but has become progressively harder to achieve as the volume of applications has increased in recent years.
TGA is now aiming to process GMP clearance applications from overseas manufacturers operating in countries that have mutual recognition agreements (MRA) with Australia within 30 working days. The regulator decided on the new timeframe after assessing its performance over the past seven months.
Over that period, TGA has typically turned MRA GMP clearance applications around in four weeks, give or take a few days. However, it has never come close to 15 days and the trend in recent months gives no reason to believe TGA is on its way to hitting such a target. This is evidently recognized within TGA.
The new target is one TGA has shown it can hit. Having dipped below four weeks in December for the first time since it began analyzing its response times in June 2015, TGA repeated the feat in February. Average processing times have been below five weeks every month since August. TGA has said it will continue to try to turn around applications as fast as possible but thinks this is best achieved by setting a timeframe it can realistically commit to.
TGA’s abandonment of the 15-day target, the use of which dates to at least 2003, follows a period in which it became overwhelmed by a sharp increase in the number of GMP clearance applications. In the 2010-11 period, TGA received 2,500 applications. By 2015-16, this number had ballooned to 5,600. That led to the lengthening of processing times. When TGA began looking at response times in June 2015, the average time taken to complete an MRA GMP clearance application was 16 weeks. This figure fell sharply in the second half of 2015, dropping to six weeks before congestion at Christmas caused it to jump back up to nine weeks. The number rose back up to nine weeks last year when TGA focused on applications submitted before the introduction of its new work management system but the regulator has since regained control.
That has given TGA the confidence 30 working days is a realistic target but it has added caveats to the timeframe. TGA will take longer than 30 days to process applications if it has liaised with other regulators to get the GMP certificate or ask the applicant for additional information or clarification.
Indian government ministers have backed the creation of a National Authority for Containment of AMR (NACA). The proposed agency will coordinate and monitor India’s actions to stem the rise of antimicrobial resistance (AMR).
Ministers from multiple government departments signed the Delhi Declaration on Antimicrobial Resistance to establish an inter-ministerial consensus on how to approach the problem. One of the points made in the declaration is the recommendation that NACA is created. The authority is seen as providing oversight and monitoring to ensure India takes sustained, effective action on AMR.
The government is yet to flesh out exactly what NACA will do and what powers it will have to ensure India makes progress in addressing AMR. NACA will likely derive part of its brief from the National Action Plan on Antimicrobial Resistance India released for consultation in February and finalized this week. As part of the Delhi Declaration, government ministers have committed to the plan’s six strategic priorities, which include a promise to strengthen regulations to optimize use of antibiotics.
Shri Nadda, India’s minister of health and family welfare, highlighted the role regulations have played in the country’s AMR efforts to date. Nadda singled out the creation of the Schedule H1 class of prescription drugs in 2014 as an example of how Indian regulators have sought to ensure the rational use of antibiotics. The move placed tighter controls on the sale of antibiotics and other drugs in an attempt to curb over-the-counter transactions and subsequent misuse of the products.
India remains concerned about the misuse of antibiotics, though. Those concerns were given global coverage earlier this year when the United States Centers for Disease Control and Prevention reported the death of a woman from an infection resistant to 26 antibiotics. The woman died in Reno, Nevada but had suffered infections and hospitalizations in India in the months before her death.
Delhi Declaration, Press Release
TGA Is advising healthcare professionals to stop using Gilead Sciences’ Zydelig in combination with rituximab in certain situations. The implementation of restrictions follows investigations by Gilead and TGA into the causes and consequences of deaths in clinical trials of the cancer drug.
Other regulators, such as the European Medicines Agency (EMA), have already placed restrictions on the use of Zydelig, but TGA’s approach is slightly different. TGA is advising against using Gilead’s product in combination with rituximab — cancer drug sold by Roche as Mabthera and Rituxan — as a first-line treatment in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have 17p deletion or TP53 mutation.
EMA targeted the same genetic mutations when it placed restrictions on Zydelig 13 months ago but its advice made no mention of rituximab. The European regulator simply advised against using Zydelig in that subpopulation. In practice, this restricted use of Zydelig in combination with either rituximab or ofatumumab, another chronic lymphocytic leukemia drug.
TGA’s position allows the use of Zydelig in combination with rituximab or ofatumumab in patients who have relapsed and are unsuited for treatment with chemo-immunotherapy. The regulator is also open to the use of Zydelig as a third-line monotherapy treatment.
EMA and TGA made the changes in response to evidence of the risk of patients suffering from Pneumocystis jirovecii and cytomegalovirus infection. Both regulators have adopted prophylactic and monitoring programs to further mitigate the risk of infection.
The Gujarat Food and Drug Control Administration (FDCA) has reportedly secured refunds for patients who were overcharged for stents in the days after the price of the devices was capped. Patients are set to receive a refund of Rs. 5,156,138 ($80,000).
Officials at the National Pharmaceutical Pricing Authority (NPPA), which implemented the cap, released news of Gujarat FDCA’s action. The move will return money to patients who paid more for stents than the capped price from 13 to 17 February, the week in which NPPA implemented the ceiling.
Before the price cap came into place, reports put the upper price of a drug-eluting stent at Rs 150,000. The figures released by NPPA suggest the patients due a refund were on average charged far less. NPPA said 79 patients are due to receive refunds. The size of the refund suggests they were charged Rs 65,268 on average.
That is more than twice the Rs 30,000 price cap on drug-eluting stents NPPA brought into force in February but is well short of some of the figures quoted in media reports of overcharging.
NPPA Post, Complaint List
Tags: Asia regulatory roundup, GMP applications, stents, antimicrobial resistance