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Regulatory News | 06 February 2018 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The Therapeutic Goods Administration (TGA) is surveying sponsors about their pharmacovigilance activities to identify high-priority targets for its new inspection program. Sponsors who fail to fill in the online survey will automatically receive the highest risk score, making them a top target for TGA inspectors.
Australia's TGA is introducing pharmacovigilance inspections to verify sponsors are complying with its regulations and ensure the collection of safety and efficacy data. TGA piloted the program in 2015 and 2016 and is now pushing ahead with a full rollout. The inspection model is based on that used by the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA). Like MHRA, the Australian agency has opted for a risk-based compliance program.
The survey marks the start of TGA's attempts to stratify the industry by risk of noncompliance with pharmacovigilance regulations. TGA's initial questions build a basic picture of sponsor's pharmacovigilance operation, for example by asking how many medicines they market in Australia and whether any are approved for use in children.
Later questions delve deeper into how sponsors organize their adverse event monitoring activities. TGA wants to know whether sponsors outsource any pharmacovigilance activities, if they audit their providers and how long it typically takes them to submit adverse event reports. If the sponsor gives honest answers, the survey will give TGA a picture of how likely a company is to be noncompliant and how serious the implications of the deviations are likely to be.
TGA will use this picture to organize its inspection plans. The agency plans to give sponsors six to eight weeks' notice of its visits, although in some cases it may perform surprise inspections. If TGA gives prior notice, it will do so in writing and may include details such as the objectives, nature and dates of the planned inspection. TGA may reinspect sponsors early if it finds evidence of significant noncompliance on its original visit.
Sponsors have until the end of March to complete the survey.
Pharmacovigilance Survey, TGA Statement
The annual number of new drug registrations in Australia has fallen to its lowest level since 2012. TGA signed off on 34 new chemical and biological entities in last year, down almost 20% on the highs of 2016.
Australia last approved so few new drugs in a calendar year back in 2012, when it registered 25 products. Since then the annual count has read 39, 39, 35, 42. The dip back down below the 35 mark came in a year when the European Medicines Agency (EMA) and United States Food and Drug Administration (FDA) both saw the number of approvals rise. FDA approved close to 50 novel drugs, more than in any year since 1996. EMA signed off on 35 new active substances.
Given the typical time lag between filings for approval in the US and Europe and Australia, the spike of approvals at EMA and FDA in 2017 may translate into an uptick at TGA in 2018. Equally, the number of approvals is less meaningful than whether the products address unmet needs. TGA thinks 2017 was a good year on that front.
"Two new first-in-class treatments were approved for spinal muscular atrophy and liposomal acid lipase deficiency," the agency wrote in its report. "Orphan drugs for the treatment of rare diseases were approved for hemophilia and Fabry disease. Notably, 2017 saw a large proportion of new registrations of immunotherapies and human monoclonal antibodies."
The dip in new drug approvals coincided with a slow year for new generic medicine registrations. TGA registered 101 generics last year, making 2017 the second slowest year since 2012. Excluding 2015, when TGA registered 94 new generics, the number of approvals in 2017 was down 18% against the average from the preceding five years.
The Central Drugs Standard Control Organization (CDSCO) of India is spending this week dealing with the backlog of grievances filed by companies. CDSCO created Grievance Redressal/Pendency Disposal week after stakeholders complained about how long it is taking the agency to process complaints.
To address the backlog, CDSCO has told all senior officers at its headquarters and zonal offices to be in their chambers in the second half of the day all this week. The officers will use this time to "address the grievances and dispose of the pending issues." The grievance redressal period covers the week commencing 5 February.
CDSCO has told officers to compile division and zone-wise reports of their activities during grievance week. The reports should state which grievances have been disposed of and which are outstanding. In the case of outstanding grievances, CDSCO expects the reports to explain why they are yet to be disposed of. The Drug Controller General of India wants to receive the report on 12 February.
The grievance week builds on early efforts by CDSCO to improve its handling of complaints. This time last year, CDSCO adopted new processes for making and handling grievances related to the recommendations of subject expert committees. The new way of working established a seven-day window for responding to complaints to stop the grievance process from dragging on.
The China Food and Drug Administration (CFDA) has outlined its strategy for encouraging innovation. Building on impetus provided by the central government, CFDA plans to promote the construction of a national clinical research center and key laboratories to establish a technological innovation base.
CFDA sees the laboratories and clinical research site as central to its plans. By accelerating work on key laboratories, CFDA hopes to equip itself to perform original research that supports the revision of standards, adoption of new technologies for inspection and testing and other advances that further its operation. CFDA calls out medical device innovation as a specific area that could benefit from its activities.
The agency presents the national clinical research center as another piece of China's innovation base. CFDA envisions the center carrying out clinical research, training personnel and participating in academic exchanges.
Support for the construction of a clinical research center and key laboratories are among the more concrete proposals put forward by CFDA. Other sections are lighter on detail but collectively paint a broad picture of how CFDA plans to create an environment in China that encourages innovation. That focus is in line with the vision sketched out by the central government last year.
CFDA Plan (Chinese)
CFDA has released its medical device standards strategy for 2018 to 2020. The document lays out how CFDA will work to improve the standard of medical equipment sold in China and revise the rules that cover the sector. One area of focus for the coming years is international exchanges. CFDA wants to deepen its ties to international organizations involved in medical device regulatory standards. CFDA Notice (Chinese)
The Drug Regulatory Authority of Pakistan (DRAP) has shared a government notification regarding the planned revision of drug specification rules. The draft amendments include the addition of a section detailing the order in which specifications should be compiled. The plan is to prioritize specifications from the US, British and European pharmacopoeias. If such no specifications are available, DRAP officials will look elsewhere. Draft Amendments