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Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Australia’s Therapeutic Goods Administration (TGA) has finalized its timelines for reporting adverse events involving biologicals. The timelines are unchanged from draft guidance published last year that was criticized by companies including Pfizer for giving sponsors too little time to act.
Under the guidance, companies have 48 hours to inform TGA of events deemed a serious threat to public health. In the event of serious and near-serious adverse events, companies have 10 and 30 days to report, respectively. The reporting timelines for "recalls, quality defects and contaminated or counterfeit biologicals" are tighter still. TGA wants to hear of such events as soon as possible.
Industry pushback against the timelines centered on the divergence from those applied to other medicines. Manufacturers of small molecules and other more conventional therapeutics have 72 hours to inform TGA of serious threats to public health and 15 days to report serious adverse events.
In establishing timelines for biologicals — products based on human cells or tissues or live animal cells, tissues or organs — TGA has looked to medical devices, not drugs, for inspiration. The timings set in the biological guidance therefore follow those established for devices. TGA thinks this is the right approach given its belief in the similarities between biologicals and medical devices.
While TGA has stood firm on the timelines, it has adapted the guidelines in response to some of the other feedback it received during last year’s consultation. The current version gives a far fuller explanation of what it means when it states the biovigilance contact person must be "permanently and continuously available."
At minimum, the contact person should be available on weekdays during Australian east coast business hours. Companies should have a backup contact person to cover for absences. Other TGA clarifications allay industry concerns about the burden of complying with the recommendations.
"Please note this means the person is contactable when required, e.g. by phone, and not necessarily on-site full-time. Ultimately, sponsors need to be confident that the person responsible for biovigilance can be reached to seek advice in emergency situations," TGA wrote.
Media reports covering the profit margins have focused on the markups added to consumables, most notably the 1,700% the hospital made on a three-way stop cock. Fortis Memorial Research Institute, the hospital at the center of the furor, bought the consumable device for Rs 5.77 ($0.09). The patient was billed Rs 106.00 ($1.70) after the stop cock was used in their care.
The report includes 13 examples of Fortis adding more than 1,000% markups to consumables and 77 cases of it charging more than 100% more than the procurement price.
Fortis has sought to move the discussion away from individual prices and discuss what patients are charged in the context of its broader operation, while also noting that its fees are in line with those charged elsewhere.
The hospital added the smallest markups to products regulated by India’s National Pharmaceutical Pricing Authority (NPPA). The difference between what Fortis paid for and charged for the price-controlled products ranged from 5% up to 343%. At the top end of the range, the markup is considerable, but Fortis told The Economic Times its prices comply with NPPA regulations.
The hospital added bigger markups to products outside the scope of NPPA regulations. Fortis profit margins for non-scheduled medicine formulations were as high as 914%. The hospital made three-figure margins on 20 such products.
What happens now is unclear. NPPA investigated Fortis after receiving an overcharging complaint and published a full breakdown of its findings in the interest of transparency. The watchdog said it will take "necessary follow up action as per existing law and within its jurisdiction." However, if, as the hospital claims, Fortis has complied with NPPA regulations it is questionable whether the price watchdog could or should do anything.
NPPA Report, The Economic Times
India has put deputy drugs controller Ranga Chandrashekhar in charge of coordinating the rollout of the Sugam online regulatory portal. Chandrashekhar’s role will entail liaising with the IT partner the Centre for Development of Advanced Computing (CDAC) to smooth adoption of the platform.
The Central Drugs Standard Control Organization (CDSCO) is particularly keen for Chandrashekhar to smooth the integration of its systems with those run by state agencies. This integration of state and national portals is a key part of the development roadmap for Sugam. Yet, as with any time two systems are integrated, it poses technical challenges that could affect operations.
CDSCO has already run into some difficulties with the rollout of Sugam. Last year, Drug Controller General of India (DCGI) Dr. GN Singh told CDAC it needed to turn Sugam into a "flawless operational platform." That comment followed the observation that the "system is not operative satisfactorily due to non-validation of the regulatory requirement."
The new leadership model should ensure CDSCO has more direct oversight and input into what is happening at CDAC, although Chandrashekhar is taking on the coordination role on top of his current responsibilities.
The China Food and Drug Administration (CFDA) has set out how it plans to change the approval process for clinical trials. CFDA proposed the revisions in response to the state government’s push to make drug regulation in China more amenable to the development of innovative therapies.
In the guidance, CFDA lays out the process sponsors must go through to get approval to run clinical trials, the evidence they will be expected to present and the timelines that apply to both sides.
The proposed workflow seeks to address two of the big issues facing Chinese biopharmaceutical regulation, namely quality and speed. In addressing quality, the guidance sets the expectation that companies will arrive at meetings with CFDA equipped with a complete summary of data gathered to date. CFDA will tell companies that have failed to consider patient safety, prepare a complete protocol or arrive with adequate data to resolve the problems.
In terms of speed, CFDA has set deadlines for each step in the approval process, most of which are measured in days. If the deadlines are followed, they should eradicate the problems with long and indeterminate approval timelines that have traditionally dogged sponsors seeking to run clinical trials in China.
CFDA is giving the industry until 14 January to comment on the draft.
CFDA Notice (Chinese)
TGA is set to introduce a revised version of its risk management plans for medicines and biologicals for consultation early next year. The planned major update to the guidance is intended to bring it in line with the recommendations of the medicines and medical devices regulation review. TGA Guidance
CFDA has given the holders of drug registration seals until the end of the month to send them back. The request follows regulatory revisions. CFDA Notice (Chinese)
Tags: Asia Regulatory Roundup, adverse event, clinical trials China