Asia Regulatory Roundup: Pakistan Seeks Expert to Help Harmonize Regulations With Global Best Practices

RoundupsRoundups | 15 October 2019 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
New Zealand Extends Timelines for Reporting Medical Device Adverse Events
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has given companies more time to report adverse events involving their medical devices.
Under the old rules, manufacturers of medical devices had seven calendar days to report incidents of actual or potential death or serious injury. The revised rules give manufacturers up to 10 days to file reports of actual or potential death or serious injury. In the United States, manufacturers have 30 days to report deaths or serious injuries, unless the event requires remedial action to prevent further harm.
The extension is one of several ways in which Medsafe has made the rules less onerous. Medsafe has also stopped requiring manufacturers to submit initial reports of minor injury events, unless the incident could lead to a market action. The old rules required companies to file initial reports of minor injuries within 30 days, but Medsafe will now generally only require the submission of a final report. Companies have 120 days to file a final report.
Medsafe disclosed the updated timelines alongside new reporting forms for industry. The forms for healthcare professionals and the public are unchanged. Medsafe also tweaked its definitions, clarifying that serious injuries must be unexpected to fall under the reporting requirements and adding information about quality issues.
The changes come as New Zealand prepares to overhaul its regulations on medical devices. The proposals will raise the bar companies need to clear to get medical devices to market and increase post-marketing requirements.
Medsafe Guidance
Australia Posts Guide to Using ‘TGA Assessed’ Claim on Medicine Labels
Australia’s Therapeutic Goods Administration (TGA) has posted guidelines on listed assessed and registered complementary medicines. The guideline addresses the use of the TGA-assessed claim companies can use to show the agency has reviewed efficacy evidence for the approved indications.
TGA agreed to allow certain complementary medicines to carry the label claim last year to enable manufacturers that follow the assessed listed pathway to differentiate their products from rivals that came to market without undergoing premarket efficacy evaluations. The agency pushed ahead with the idea despite opposition from drugmakers including Pfizer and Sanofi that argued the label claim could give complementary medicines an unearned edge over over-the-counter pharmaceuticals.
The willingness of TGA to push ahead in the face of opposition led to the guidelines published this week. The guidelines detail the symbol and TGA-compliant statement products can carry. Only assessed listed medicines and registered complementary medicines that have undergone premarket efficacy assessments can carry the label and statement.
TGA will allow companies to put the TGA-assessed statement and symbol anywhere on the label, including on the primary packaging. The caveat is the “TGA-assessed claim must be balanced against other information on the main label and primary pack to assist consumers in selecting and using a medicine.” Companies cannot make the TGA-assessed claim more prominent than the required label information.
The guidance provides minimum and maximum sizes for the TGA-assessed symbol and statement and prohibits companies from changing the color and shape of the symbol. However, TGA is willing to let companies use different fonts and colors for the statement, provided the text contrasts strongly with the background and is stylistically consistent with other information on the label.
TGA’s restrictions extend to the use of the symbol and statement in advertising. Companies can show labels that carry the symbol or statement but cannot display the claims outside of the context of an image of the product packaging. Companies cannot comment on the TGA-assessed claim in audible or written commentary to accompany an advertisement.
Manufacturers of complementary medicines that want to make TGA-assessed claims need to send copies of the proposed labels to the agency. TGA “will consider all aspects of the medicine’s presentation for compliance with the various legislative requirements” before deciding on whether to authorize a company to make the claim.
TGA Guidelines
Pakistan Seeks Expert to Help Harmonize Regulations With Global Best Practices
The Drug Regulatory Authority of Pakistan (DRAP) is recruiting a consultant to help it harmonize its rules and regulations with international best practices. DRAP wants the consultant to work on areas including licensing, registration, inspection, market surveillance and pharmacovigilance.
Harmonization is one of nine items on the scope of work shared by DRAP. Some of the other items on the list also relate to harmonization. For example, DRAP wants the consultant to help it prepare to meet the requirements of Pharmaceutical Inspection Co-operation Scheme membership and attain the next maturity level in the World Health Organization’s global benchmarking tool.
DRAP also wants the consultant to help it draw up a roadmap for signing a memorandum of understanding with other regulatory authorities. The goal is for DRAP to cooperate with its global peers on areas including compliance with manufacturing rules and regulatory information sharing.
Other related tasks awaiting the consultant include improving DRAP’s inspection, enforcement and compliance activities in line with international standards. DRAP hopes that change will help grow exports of pharmaceuticals. Another point on the scope of work is focused on the development of a framework for how DRAP and the Pakistani drug industry can work to increase exports.
The scope of work also addresses the development of guidance on topics including clinical trials, the creation of a framework to strengthen DRAP’s user fee program and the improvement of a quality management system.
DRAP is accepting proposals from consultants interested in taking on the work until 28 October. 
DRAP Notice
Medsafe Clarifies Process for Extending the Shelf Life of Reference Standards
Medsafe has updated its guideline on obtaining approval for new and changed medicines. The latest text features a new section setting out the process for extending the shelf life, expiry or retest date of a reference standard.
Manufacturers use reference standards as comparators in determinations of the biological activity and potency of biological test samples, making them central to quality control. In New Zealand, the process is described in a data requirement annex to the guideline on obtaining approval for new and changed medicines.
This week, Medsafe updated the guideline, notably by adding a new section to the data annex about making changes to the shelf life, expiry or retest date of reference standards. The new section splits reference standards up into those with and without a protocol for the retest or expiry date.
If a previously approved protocol is in place, Medsafe wants companies to use a self-assessable change notification (SACN) to extend the shelf life. The applicant should include relevant data in the filing, as well as an assurance that no other changes are made. Medsafe wants applicants to notify it immediately in the event of aberrant results.
Companies that lack an approved protocol follow a different process. Medsafe wants companies in that situation to file a changed medicine notification, plus appropriate data. Applicants can include a protocol that would permit them to file an SACN in the future in the filing.
Medsafe Guideline
Other News:
India’s Central Drugs Standard Control Organization (CDSCO) has provided further guidance on external performance evaluation of in vitro diagnostics under the Medical Device Rules, 2017. The guidance clarifies previous publications on the topic. CDSCO Notice


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Tags: DRAP, Medsafe, TGA

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