Asia Regulatory Roundup: Australia, Singapore Expand Generic Drug Work-Sharing Trial (12 December 2017)

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Australia, Singapore Expand Generic Drug Work-Sharing Trial

A regulatory consortium featuring Australia and Singapore has expanded its generic medicine work-sharing program. The initiative allows companies to file for approval with multiple agencies, which then perform a coordinated assessment of the application before reaching individual decisions.

Agencies in Australia, Singapore, Canada and Switzerland — the members of the ACSS Consortium — are behind the initiative. Companies that want to participate in the trial can submit filings to two or more of the regulators simultaneously. The regulators will then work together on the filings, with one agency generating an assessment report on modules 2 to 5 for review by its peers. Each agency will review module 1 independently and reach their own final approval decision.

ACSS sees the program lessening the regulatory burden on companies by enabling them to file a common dossier to multiple agencies. The model could also shave time off the approval process in some territories. ACSS foresees the review process taking 175 to 205 days. That is less than some of its members take on traditional, single-agency applications.

Further down the line, there is a desire to use the work-sharing trial as a launchpad for bigger regulatory collaborations.

“The trial has the potential to provide a model that could be adopted on an even larger scale,” the Therapeutic Goods Administration (TGA) of Australia wrote. “The valuable knowledge and experience obtained through this pilot exercise will inform internal procedures on the effective use of foreign assessment reports as well as collaborative work with international regulatory partners.”

News of the creation of the trial comes one month after TGA discussed the first application to be processed collaboratively by the agencies. In that case, TGA took the lead and received support from its peers in Canada and Switzerland. All three agencies ended up recommending the drug for approval, but it took longer than expected to reach these decisions.

TGA attributed the overrun to the filing being more complicated than originally thought. This led to the applicant taking longer than anticipated to respond to the first round of questions and to an unforeseen second round of questions. The upshot is the overall process took nine months, four months more than the original goal.

That experience led to a revised workflow and timelines that ACSS will use in the new trial, plus a willingness to expand beyond the initial focus on solutions and immediate-release solid doses. All dosage forms are eligible for the current trial.

Not all the proposed changes made it into the trial, though. As of last month, TGA expected to limit future generic drug work sharing submissions to two of the four agencies in the consortium. However, the trial now underway is encouraging companies to apply to “at least two, but preferably more” ACSS members simultaneously.

TGA Notice

Pakistan Seeks Feedback on Draft Pharmaceutical Marketing Code

Pakistan plans to more rigorously limit and oversee interactions between medical companies and healthcare professionals. The draft code is intended to increase public confidence in the industry and ensure all medical decisions are in the best interest of patients by stopping unethical activities.

The draft covers many of the same points as ethical drug and medical device marketing codes used in other parts of the world.

Under the code, manufacturers can engage healthcare professionals as consultants, but only if they comply with certain stipulations. Consultants can only be hired for legitimate needs, in reasonable numbers, selected on merit — not sales volumes — and paid at the fair market value by check or bank transfer. Similar stipulations apply to travel expenses.

The code also applies limits to meals, activities, educational items and gifts. Companies can sponsor or organize meals at educational conferences, business meetings and training sessions, but they must be “modest” in cost and incidental to the main purpose of the event. Entertainment at the meals is prohibited under the code, as are recreational activities in general. The ban on the provision of recreational activities forms part of a broader prohibition of gifts of any value.

Companies can provide educational items, but they must be modest in cost and “benefit patients or serve a genuine educational function.” Pakistan is proposing to allow companies to spend more on certain items, such as textbooks and anatomical models, but the outlay on these “should not be extravagant.”

If the code comes into force, attention will then turn to the extent to which the Drug Regulatory Authority of Pakistan (DRAP) is able to enforce the rules. The code puts some of the onus for the effective implementation of its rules on companies, which must put a senior executive in charge of compliance, adopt guidelines, provide training and get the buy-in of the C-suite and board. 

Individuals who fail to comply with the rules could face imprisonment. The punishment section of the draft code refers to two schedules of the DRAP Act 2012, which allow for the life imprisonment of people who violate certain rules twice. A range of lesser sentences and fines are also available to the legal system.

Draft Code

Australian Watchdog Accuses GSK, Novartis of Misleading Consumers

An Australian watchdog has accused GlaxoSmithKline and Novartis of misleading consumers. The accusation centers on two brands of pain relief products, which the watchdog says are identical formulations marketed to different groups of patients at different prices.

The Australian Competition and Consumer Commission's (ACCC) case centers on Voltaren Osteo Gel and Voltaren Emulgel. Both brands contain 11.6mg per gram of diclofenac diethylammonium, and as such should be equally effective at treating local pain and inflammation wherever they are applied.

As ACCC sees it, GSK and Novartis have marketed Osteo Gel as a more effective treatment for osteoarthritis and charged a premium for the brand. GSK has previously argued the price difference stems from the use of a different cap on the Osteo Gel product that is designed to be easier to open.

ACCC has a different take on the situation.

“We allege that consumers are likely to have been misled into purchasing Osteo Gel thinking that it is different to Emulgel and more effective for treating osteoarthritis conditions, when this is not the case,” ACCC Chairman Rod Sims said. “The alleged conduct is particularly concerning, given the significant penalties handed down by the court against the makers of Nurofen for what we consider to be similar conduct.”

The Nurofen case culminated in an Australian court fining Reckitt Benckiser AU$6 million ($4.5 million) for creating brands that targeted different types of pain despite containing the same active ingredient at the same dose.

In theVoltaren case, ACCC “is seeking declarations, injunctions, pecuniary penalties, a publication order, the imposition of a compliance program and costs.” The watchdog is pursuing the case in the Federal Court of Australia.

ACCC Notice

Other News:

An Asian regulatory harmonization group has called for comments on multiple documents. The group put out seven calls for comment in the second half of last week. The requests covered texts that spanned a wide range of topics, including the 3D printing of medical devices, postmarket clinical follow-up studies and conformity assessments of in vitro diagnostics. The comment periods on the texts have now closed.  AHWP Requests