Asia Regulatory Roundup: TGA Extends Drug Shortage Reporting Deadlines Following Industry Feedback

Regulatory NewsRegulatory News | 26 June 2018 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Extends Drug Shortage Reporting Deadlines Following Industry Feedback
The Therapeutic Goods Administration (TGA) of Australia has revised its planned policy on managing drug shortages in response to feedback from the industry. Manufacturers pushed back against the reporting timelines and other measures proposed by TGA, leading the agency to revise its position ahead of the framework coming into force.
When TGA began the consultation in April, it planned to give manufacturers two days to respond to its queries about possible shortages. TGA proposed the deadline to remedy a problem it faces today, whereby it often learns of shortages from patients and healthcare professionals and then struggles to confirm the issue with the manufacturer. The agency sees the deadline for responding to its queries preventing the significant delays that arise today, but manufacturers took issue with the proposal.
“This reporting timeframe does not allow enough time for comprehensive verification of an out-of-stock report especially when it has occurred further down in the supply chain,” trade group Medicines Australia wrote in its response to the consultation. Medicines Australia also found fault with how far in advance TGA expects manufacturers to alert it to discontinuations. 
TGA has tweaked the reporting timelines in response to the comments of Medicines Australia and other organizations. Manufacturers still have two days to provide key information about a shortage, but TGA is allowing them another three days to submit the remaining information. However, while TGA showed flexibility on that point, it stood firm on the discontinuation timeline. TGA still wants to hear about discontinuations likely to have a critical impact 12 months before they happen.
The agency made concessions to the feedback in other areas. TGA has tightened up the definition of a medicine shortage to clarify that it only applies when demand is likely to outstrip supply for all of the patients in Australia at anytime over the next six months. The revision heads off concerns that the breadth of the earlier definition and penalties for noncompliance would lead to over-reporting by manufacturers. That could have created problems for TGA.
“It is unclear whether the TGA intends to manage every shortage report submitted by sponsors, and thus the ability of the TGA to effectively triage and manage shortage reports is questioned,” Medicines Australia wrote.
TGA also received pushback from manufacturers regarding its proposed penalties, although that was offset by the feedback of healthcare professionals who advocated for strong, criminal punishments for noncompliance. In response, TGA is proposing to change the legislation to create a civil penalty provision for people who break the reporting requirements. TGA will initiate civil penalty proceedings in the most serious cases. For lesser infringements, TGA may publish the sponsor's name or issue an infringement notice.
TGA Update
New Zealand Seeks Feedback on Major Revisions to Clinical Trial Guidelines
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has released revised clinical trial guidelines for consultation. Medsafe is revising the document in light of the emergence of online applications and problems with site self-certification since it was last reviewed in 2015.
Some of the biggest changes relate to the requirements of clinical trial sites. In the 2015 guideline, Medsafe tasked “the person responsible for clinical trials at the site” with completing a self-certification form. This wording led to multiple people from the same site submitting forms. To avoid that situation, Medsafe is proposing to clarify that responsibility for self-certification rests on “the person who manages the site.”
Medsafe has also clarified which clinical trial sites need to self-certify. The 2015 document refers to participants being “in residence” and procedures to deal with “emergencies” without defining these terms. Medsafe has tried to make the wording clearer in the revised version.
“If study participants are staying overnight or longer for monitoring purposes as a result of receiving a study medication, information about the facilities and procedures in place to deal with possible emergencies (Critical Incidents) arising from the study medication must be provided,” Medsafe wrote. “A Critical Incident is described as a life-threatening or disabling event arising from the study medication.”
The changes to the site notification section have implications for clinical trial sponsors. Seeking to simplify sponsor responsibilities, Medsafe is proposing to drop the requirement for applicants to specify whether their trial sites have complete, current certifications. Instead, Medsafe wants sponsors to check their trial sites against a list of notified sites whenever they start a study that requires subjects to stay overnight.
Elsewhere, Medsafe is proposing to delete a lengthy section on how to make a paper-based application as it has stopped accepting such submissions. The earlier version featured a small section on making an online application that Medsafe plans to modify slightly in the current review. Medsafe will add some basic instructions regarding online applications, but is pointing readers to its website for a detailed explanation.
Most of the other sections are set to be revised, too. These changes will enable good manufacturing practice audits of facilities that make drugs for clinical trials, clarify reporting timelines for non-fatal adverse events and add details about when sponsors need to seek approval to run a study.
The draft is open for comment until 3 August.
Medsafe Notice
India Moves to Bring Implants and Imaging Equipment Under Drug Legislation
India is planning to categorize implantable devices and other “high-end equipment” as drugs. The move would make the medical equipment subject to the regulatory requirements placed on drugs in India.
In a request for comment, the Drug Controller General of India (DCGI) Dr. Eswara Reddy listed eight types of medical device that could be reclassified as drugs next year. The categories of device are:
  • All implantable medical devices
  • CT scan equipment
  • MRI equipment
  • Defibrillators
  • Dialysis machines
  • PET equipment
  • X-ray machines
  • Bone marrow cell separator
Reddy’s proposal comes one month after the Drugs Technical Advisory Board (DTAB) voted in favor of reclassifying certain devices as drugs. Bone marrow cell separator was absent from the list of devices discussed by DTAB. Otherwise, the list discussed by DTAB and proposed for reclassification by DCGI are identical.
Reddy is accepting feedback on the planned changes for 21 days. The plan is to bring the changes into force 12 months after they are published in the Gazette of India.
DCGI Notice
TGA Revises Approach to Annual Survey to Target Consumers
TGA is targeting consumers with an annual survey for the first time. The agency has published a survey featuring questions aimed at consumers, rather than have them fill in the same form as sponsors, healthcare professionals and other stakeholders.
In the past, TGA has run one survey for everyone. However, the different interests and priorities of consumers have prompted TGA to single them out. This year, TGA is promoting one survey to consumers and another to all other stakeholders.
The shorter, consumer-focused survey asks questions about the respondent’s life, whether they had previously heard of TGA, what they think the agency regulates and how they rate its performance. TGA wants to gauge consumer perceptions of its fairness and trustworthiness. Other questions ask about the experiences of consumers who have interacted with TGA in the past.
TGA is accepting survey submissions until 20 July.
TGA Notice
Other News:
The Central Drugs Standard Control Organization (CDSCO) has approached the Press Council of India about taking action against newspapers that published articles it views as defamatory. CDSCO Notice


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