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Regulatory Focus™ > News Articles > 2020 > 9 > Asia-Pacific Roundup: TGA advises on Consumer Medicine Information summaries

Asia-Pacific Roundup: TGA advises on Consumer Medicine Information summaries

Posted 01 September 2020 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA advises on Consumer Medicine Information summaries

Templates for preparing summary pages for Consumer Medicine Information (CMI) documents cover six questions intended to help consumers understand how and why they are taking a medicine, according to new guidance from Australia’s Therapeutic Goods Administration (TGA).
 
The guidance anticipates new TGA requirements for CMI documents for newly registered prescription and some non-prescription medicines that go into effect in January 2021. Sponsors of medicines that come to market before the end of this year have until late 2025 to adopt the new CMI format.
 
The six questions are
  • Why am I using [the medicine]?
  • What should I know before I use [the medicine]?
  • What if I am taking other medicines?
  • How do I use [the medicine]?
  • What should I know while using [the medicine]?
  • Are there any side effects?
 
The guidance provides advice on how companies should respond to the questions, for example by recommending against the use of medical or technical terms when summarizing a drug’s approved indications. Elsewhere, TGA gives sponsors the option to provide just a portion of the relevant information if a full response would use too much space. Sponsors that take up that option can use phrases such as “there are many important things to consider while you are taking this medicine.”
  
TGA has created an example summary page for atorvastatin (Lipitor), to help companies complete templates for their own medicines.
 
TGA Guidance
 
India to resume limited export of N95 face masks
 
India’s Directorate General of Foreign Trade (DGFT) has partly lifted a ban on the export of N95 face masks.
 
Following the blueprint it established for items including medical goggles, DGFT is relaxing the total ban on the export of N95 masks imposed early in the COVID-19 pandemic by allowing companies to apply for a share of a monthly quota. DGFT plans to allow companies to ship 5 million masks a month in August and September. The application window does not open until 7 September.
 
Successful applicants will receive an export license that is valid for three months. The licenses will set the companies up to help meet global demand for N95 masks, respirators that conform to standards designed to ensure the efficient filtration of airborne particles.
 
In late July, 3M said it is set to more than triple production this year, bringing total output up to 2 billion, but despite that “demand continues to far outpace what the entire industry can supply.” Other US mask suppliers such as Honeywell have also increased their production capacity at sites around the world.
 
Honeywell’s expansion covered its operation in India. The DGFT change could facilitate the export of N95 masks from India, although the current quota is likely too small to make a huge difference to global supplies.
 
DGFT Notice, More
 
Philippine FDA establishes policy for local inspections during the pandemic
 
The Philippine Food and Drug Administration (FDA) has set out when and how it will perform local risk-based inspections while quarantine measures are in place to slow the spread of COVID-19.
 
In a circular published in March, FDA authorized inspectors to assess establishments that are close to their municipality or city. The circular published last week provides additional information about how the inspection program will work in practice.
 
FDA is asking its inspectors working in areas of the country under quarantine measures to defer pre- and post-licensing assessments, routine visits and other low-priority inspections unless their safety can be assured and the need for the action can be justified. In the absence of such assurances and justifications, FDA staff are to write to establishments to explain the deferral of their inspections.
 
The circular features a tool for assessing when and where it is safest to conduct an inspection. The tool factors in information on the community quarantine level and the number of active cases in an area, plus the expected duration of the inspection, to determine whether a visit is high or low risk.
 
For inspections deemed high risk, FDA is advocating fully or partly remote assessments. The on-site parts of hybrid assessments should take place “under agreed controlled conditions.” FDA has cleared inspectors to perform fully or partly on-site assessments of low-risk establishments.
 
When remote assessments are needed, FDA wants inspectors to use virtual meeting and file sharing software. In-person inspections should be as short as possible “without compromising the inspection agenda” and involve one or two people from the establishment who interact with FDA. 
 
FDA Circular
 
Malaysia updates guide to clinical trial import licenses and exemptions
 
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has revised its guideline for applicants seeking clinical trial import licenses and exemptions. The guideline, the seventh version of the text, contains new advice on topics including first-in-human clinical trials.
 
NPRA released version 6.4 of the guideline in 2017. According to NPRA, the Malaysian clinical trial sector has experienced “robust growth” since then, driving the agency to update the document to make it more useful for the industry. Many of the changes relate to first-in-human trials, a term only used twice in version 6.4 of the guideline.
 
The latest version of the text features a description of first-in-human clinical trials in the introduction, which explains that traditionally used herbal products and generic medicines cannot be the focus of such studies.
 
Elsewhere, NPRA outlines the stability data needed for first-in-human studies, explaining that at least one batch must undergo accelerated and real-time testing for one month or more, and provides a flow chart for sponsors that want to test a medicine in humans for the first time. The application process for first-in-human trials is similar to the standard process but features additional steps, such as the input of an expert panel and evaluations of the submissions at two meetings.
 
NPRA has also created a template declaration for sponsors of first-in-human trials. The declaration states the sponsor is aware of their responsibilities under Malaysian laws and regulations and will indemnify the Drug Control Authority “against all actions, claims or proceedings in respect to any loss, injury or death of any person whomsoever arising out of or in connection with the aforementioned clinical trial.”
 
NPRA Guideline
 
Other News:
 
Australia has adopted new definitions of “medical device” and other terms. The changes, which took effect last week, were discussed in a public consultation late last year. The new medical device definition covers software, implants and reagents, terms that were missing from the outgoing text, and the use of products in the prediction and prognosis of disease. TGA Notice
 
India’s National Pharmaceutical Pricing Authority (NPPA) has published a memo detailing a revised process for handling applications. The move to the online application process is part of a broader effort to improve the ease of doing business. NPPA Memo
 

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