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Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The Therapeutic Goods Administration (TGA) is set to adopt a tougher line against companies that fail to submit complete good manufacturing practice (GMP) clearance applications. TGA’s revised policy strips applicants of the opportunity to submit outstanding supporting evidence before their filing advances to the assessment stage.
Australia’s TGA will apply the new approach to all compliance verification applications it receives from 26 September onward. TGA adopted the approach to mitigate the administrative challenges created by the sharp rise in the number of requests for clearance to manufacture drugs overseas. In the 2014-15 financial year, TGA received 4,000 such applications. Last year, the number of filings hit 6,000. That represents a 140% increase since 2010.
TGA estimates 60% of these applications lack some of the supporting evidence needed to show a production plant is acceptable for the supply of therapeutic drugs. In the past, TGA officials have made multiple attempts to contact these applicants and get them to submit the evidence. This extra work contributed to TGA failing to hit its processing timeline targets. Applicants that filed complete applications suffered delays because of the failings of other companies.
The new policy is designed to address this problem. For applications submitted until 26 September, TGA will contact companies once to request unfiled supporting evidence by a certain date. If the firm fails to meet the deadline, the incomplete application will advance to the assessment stage. TGA will take an even tougher line from 26 September onward. Applications submitted on or after that date will advance without TGA giving the company a chance to fix any gaps in the submission.
TGA’s tougher stance continues into the assessment stage. If TGA identifies deficiencies or has questions for the applicant, it will send a note requesting the additional information by a particular date. After this date, TGA will assess the application on the basis of the information it has at that time.
In some cases, TGA will infer the meaning of incorrect applications rather than confirm the details with the manufacturer. This applies to the scope of applications. If, for example, an application covers an “active material manufacture” step but lacks evidence showing the site performs microbiological testing, TGA will change the step to “active material manufacture excluding microbiological tes
Publication of the revised policy comes five months after TGA dropped its 15-day processing target for GMP clearance applications. TGA dropped the target, which had existed for more than a decade, after a period in which processing times ranging from four to 16 weeks persuaded it a 30-day goal was more realistic.
The Indian government is preparing for a final hearing on its long-running attempt to ban the sale of 344 fixed-dose combination (FDC) products. Government officials are set to make their case for outlawing the FDCs at the Supreme Court in an attempt to overturn a ruling by a lower court that sided with drugmakers.
Indian regulators proposed to ban 344 FDCs that they deemed to be irrational 18 months ago, only for immediate pushback from manufacturers to mire the clampdown in a legal tussle. Drugmakers filed hundreds of petitions against the ban. These petitions argued the committee set up to assess FDCs reached its decisions without giving manufacturers show cause notices. The government said it gave companies 90 days to make cases for their products. Yet, in a ruling that called the process followed by the government “haphazard,” the Delhi High Court sided with manufacturers.
The government appealed the December 2016 ruling the following month, but there has been little progress since. The Supreme Court halted proceedings against the ban in all high courts in March. At that time, the Supreme Court was expected to hear the case in July but the date later slipped to 19 September.
With the court date now nearing, the Central Drugs Standard Control Organization (CDSCO) has published a notice about the final hearing. The notice alerts interested parties to the date and lists the hundreds of petitions that will be affected by the ruling. CDSCO is advising interested parties to send submissions to the Supreme Court on the day of the hearing, adding that the case will go ahead with or without their contributions.
The decision the Supreme Court reaches will have implications beyond the 344 FDCs. One of the arguments made by the petitioners — and accepted by the Delhi High Court — is that the government should have consulted with the Drugs Technical Advisory Board (DTAB) and the Drugs Consultative Committee (DCC) before ruling against the FDCs. The government unsuccessfully tried to dismiss this argument by stating nothing in the Drugs and Cosmetics Act, 1940 mandates such consultations.
If the Supreme Court also rules against the government’s interpretation of the law, it would leave the door open for drugmakers to mount legal actions against other decisions CDSCO takes without first consulting with DTAB and DCC.
Medicines Australia has welcomed many of TGA’s proposed changes to its scheduling policy framework (SPF). The trade group agrees with TGA’s plans to split the SPF into policy and guidance texts and form an informal working group to advise on changes to the poisons standard.
TGA has responded to the positive feedback by committing to enacting some its proposals. The division of the SPF into two documents and creation of an informal working group are among the ideas set to move forward. TGA has started to flesh out what this will mean in practice, notably by stating the first three chapters of today’s SPF will form the policy document. The agency will tweak the remaining chapters to create the guidance document.
Officials have also decided to commit more time to assessing the merits of mooted changes to the framework that would result in interim decisions being subject to full public consultations. The mooted changes would also provide scope to double the two-week consultation period, if deemed appropriate.
TGA has backed away from other ideas, though. The agency no longer plans to introduce market incentives that encourage the down-scheduling of applications.
Consultation Submissions, Medicines Australia Response
CDSCO has expanded its consultation on the long-discussed plan to move the industry from gelatin to cellulose capsules. The agency put out a call for comment earlier this year and has now gone to the industry again “in order to have a wider consultation.”
Both the recent calls for comment emanated from an expert committee formed to consider the pros and cons of India forcing manufacturers to switch from gelatin to cellulose-based capsules.
The proposal has faced fierce, sustained criticism — one observer said it would cause “chaos” — but it has been taken seriously in some quarters since the Bureau of Indian Standards released a technical document in 2015.
That document led an advisory panel to recommend enacting the change and to three requests for feedback in nine months. The Drug Controller General of India made the first of those requests late last year, at which point it looked like the matter could be resolved by May.
Tags: Asia Regulatory Roundup