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Regulatory News | 22 November 2016 | 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) of Australia is seeking feedback on a planned priority review pathway for medical devices. TGA is asking the industry to comment on its proposed criteria for awarding priority review status, the timeframes device developers on the pathway will face and its implementation plan.
Publication of the document comes weeks after TGA began similar consultations about priority reviews and provisional approvals of drugs. The proposed pathways stem from an expert panel review the Australian government commissioned. Two of the more than 50 recommendations made by the panel called on TGA to expedite approval of medical devices in certain circumstances and develop transparent criteria for the assessment of applications for priority review. The document published by TGA this week addresses these recommendations.
Officials plan to spend fewer than six weeks assessing whether to accept each request for priority review. If the device is deemed eligible for the pathway, the sponsor then has three months to file for approval. Applicants who fail to meet this deadline risk losing the designation. Rejection by a foreign regulator and failure to continue meeting eligibility criteria can also result in the loss of the status. If a submission avoids these setbacks, it will benefit from “front of queue processing.” TGA wants the industry to tell it if the proposed timeline is realistic.
The regulator is also seeking feedback on its criteria. TGA used the US Food and Drug Administration’s (FDA) criteria as a starting point, but has emerged with a list that differs in several ways from that created by its peer. The Australian criteria add devices designed to prevent diseases and conditions to the list eligible for inclusion. TGA has also tweaked the language used to describe the types of diseases and conditions covered by the pathway. The regulator dropped “irreversibly” in favor of “seriously” to describe the types of “debilitating” diseases eligible for priority review.
Other areas of the Australian criteria also feature tweaked language. While FDA uses “meaningful” to describe the degree of clinical advantage over alternatives a device must offer to join the pathway, TGA opts for “major.” TGA also elaborates on how companies can demonstrate such advantages. The regulator will not accept engineering or preclinical data as the sole source of evidence of an advantage. Device developers must provide clinical evidence. Finally, TGA has included a line about in vitro diagnostics, a class of devices absent from the FDA document.
Having put together the criteria, TGA is asking for feedback on whether the policy is stringent enough to prevent large numbers of devices being accepted onto the priority program. The regulator thinks widespread use of the pathway would undermine its “priority” status.
TGA published the priority review consultation document alongside a text about the designation of conformity assessment bodies for medical devices. The comment period for both consultations closes on 11 January.
TGA Consultation, More
TGA has identified a need to improve its collaboration, consultation and feedback after polling 2,797 people about the effectiveness of its activities. The survey found approximately one-in-five people think TGA is failing to listen to feedback and conduct timely consultations.
In the survey, TGA asked respondents to state their level of agreement with statements. Responses to statements about the reputation and integrity of TGA and most other topics reflected well on the regulator, with the majority of respondents agreeing the agency was succeeding in these areas. However, responses to the seven statements in the collaboration, consultation and feedback section revealed dissatisfaction with the performance of TGA.
Fewer than 50% of respondents said TGA listens to feedback, is collaborative or provides a range of feedback channels. Respondents were equally dismissive of statements about the timeliness of TGA’s consultations and provision of opportunities to give input on decisions affecting their activities. Between 14% and 23% disagreed with the statements. The statement “TGA consultation is timely” was subject to the most dissenting responses.
Respondents from the medical products industry typically gave more positive answers than retailers and other groups, but many were still critical of TGA. Fewer than 50% of industry respondents said TGA listens to feedback, conducts timely consultations or is collaborative. As was true for all types of respondents, medical products professionals were particularly critical of the timeliness of TGA consultations.
The feedback gives TGA an outline for how to better serve the industry. “There is ample opportunity for improvement in the outcomes observed,” the agency wrote. “Specific areas for focus include perceptions around the timeliness of consultation, listening to feedback, providing opportunities for input and collaboration.”
The Drug Controller General of India (DCGI) has provided an update on the status of its risk-based approach to inspections of manufacturing facilities. Inspectors following the recently adopted criteria have now assessed 76 facilities, but the extent to which the visits have raised standards is unclear.
In a notice, DCGI Dr. GN Singh said inspectors have provided manufacturers with feedback on failings at their facilities that need fixing. However, DCGI is yet to hear back from state regulators about what actions manufacturers have taken in response to the feedback. In the absence of these details, DCGI is planning to re-inspect the facilities to assess whether manufacturers have acted on the advice.
Singh expects re-inspections to start in January. The regulator is yet to give individual units details of the re-inspection program, but plans to do so “in due course of time.” Given the uncertainty over the timing of each re-inspection, Singh is encouraging manufacturers to fix the noted deficiencies as soon as possible.
The Central Drugs Standard Control Organization (CDSCO) released details of its risk-based approach to the inspection of manufacturing facilities in May. CDSCO framed the approach as a way to improve the quality of medicines made in India. CDSCO officers are performing the inspections alongside their peers at state drug regulatory agencies.
The Drug Regulatory Authority of Pakistan (DRAP) has called drugmakers to a meeting to discuss the “Say No to Corruption” campaign. DRAP’s involvement in the campaign continues the agency’s recent attempts to clear its reputation for corruption.
Pakistan’s National Accountability Bureau (NAB) began the campaign earlier this year and recently agreed to extend it into 2017. DRAP’s involvement to date has included a seminar on transparency in drug pricing and an initiative to add the “Say No to Corruption” slogan to medicine packages. This week’s meeting builds on these efforts by gathering trade groups and high-level regulatory officials to discuss the campaign.
The list of regulatory officials asked to attend the meeting include some who have previously been investigated by NAB. In 2014, Pakistani newspaper DAWN reported Sheikh Akhtar Hussain and Sheikh Faqeer Mohammad had made the seven-person shortlist for DRAP CEO despite facing separate NAB inquiries. The third official asked to attend the meeting has a lower profile.
When DRAP finally named Dr. Muhammad Aslam as CEO last year, the appointment of someone from the private sector was widely seen as an attempt to eliminate a culture of corruption.
Tags: Asia Regulatory Roundup, accelerate assessments medical devices