Asia Regulatory Roundup: TGA Offers Guidance on High-Risk IVD Online Applications (13 September 2016)

Posted 13 September 2016 | By Nick Paul Taylor

Asia Regulatory Roundup: TGA Offers Guidance on High-Risk IVD Online Applications (13 September 2016)

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

TGA Posts Guide to Online Application Form for High-Risk IVDs

TGA has released a guide to using its online application form for Class 4 in-house in vitro diagnostic (IVD) devices. In keeping with recent guides created by TGA, the IVD document is a comprehensive walkthrough of the process of applying online for devices that fall into the highest-risk category.

Class 4 IVDs are described by TGA as posing a “high public health risk,” making them products of particular interest to the regulator. That said, the guide released this week is more concerned with the minutiae of using the Class 4 online application form than the risks posed by the IVDs covered in the filings.

The guide provides descriptions and screenshots for each step in the process of using the online form, from the selection of the appropriate category at the start of the filing to the submission and validation of the completed application. TGA has also linked to pages that provide details beyond the scope of its procedurally focused guide.

Publication of the guide comes one month after TGA released a similarly comprehensive overview of the online form for registered complementary medicines. While the complementary medicine text was a revision of an earlier guide, the Class 4 in-house IVD document is new.

TGA Guide

CFDA Puts Medical Device Monitoring Platform out to Tender

China Food and Drug Administration (CFDA) has put the procurement of a medical device monitoring platform out to tender. The timeline set out in the materials gives organizations until 28 September to submit their applications to win the contract.

CFDA has shared few details of the specifications of the platform it wants to procure, although more information is available to potential applicants upon request. A computerized translation of the limited details that are available publicly suggests CFDA is describing the system as an “internet information and transaction monitoring platform” for medical devices.

While this brief description falls well short of explaining CFDA’s goals for the platform, it suggests it fits with two trends in the regulator’s areas of focus. CFDA has spent the past few years overhauling its approach to multiple aspects of the development, production and marketing of medical devices. The platform could support efforts to oversee the implementation of these revamped regulations.

Equally, in looking to the internet to support regulatory activities, the platform is in keeping with the intensification of CFDA’s online activities. Last month, CFDA awarded AsiaInfo Technologies a contract to develop a regulatory data sharing platform. The regulator has also spoken recently about how it has adapted its media practices in response to the rise of social networks in China.

CFDA Tender (Chinese)

Pakistan Revises Procedure for Allocating Quotas of Controlled Substances

The Drug Regulatory Agency of Pakistan (DRAP) has published revised guidelines for the allocation of quotas of controlled substances. In the text, DRAP details the requirements companies must fulfill and the forms they must complete to be granted quotas of controlled substances under the system.

DRAP starts the guideline, which it also refers to as a standard operating procedure, by stating firms must submit controlled substances applications by 7 January. Applications are expected to include data on their current use of controlled substances from up to 31 December of the previous year. By following this process, companies can gain clearance to use substances such as morphine, pethidine and diazepam at their manufacturing plants and, potentially, the right to export a proportion of their quotas.

Before DRAP will provide such clearances to companies, it wants to review information about their operations. Specifically, DRAP is demanding that manufacturers provide it with documents that address 11 topics. These topics are detailed on a checklist, which covers everything from statements regarding activities to prevent diversion of controlled substances, to breakdowns of the production and sales records achieved by the company in previous years. DRAP has provided forms companies can use to show how their quotas were used, and ultimately sold, over the past few years.

The objective of the process is to ensure controlled substances are only used for legitimate purposes. Responsibility for deciding whether to approve a filing falls on the Ministry of Narcotics Control, the Anti Narcotics Force and DRAP. Officers from each organization make up a committee that assesses submissions, and sends details of any shortcomings to the applicant within a week of meeting to talk about its filing. Applicants then have 15 days to respond to the committee’s initial report.  

DRAP Guidelines

TGA Starts Search for Committee Members and Expert Advisors

The Therapeutic Goods Administration (TGA) of Australia has begun searching for people who can sit on its statutory advisory committees or offer specialist advice. TGA has initiated the search to ensure it has access to advice on topics spanning from premarket approval to postmarket safety.

While both committee members and specialist advisors are expected to offer input on technical regulatory matters facing TGA, the nature of their roles differs. Committee members are appointed by the Minister for Health for two- or three-year terms and expected to attend anything from three to six meetings each year. The Australian Remuneration Tribunal sets the level of compensation people receive for contributing their time to the committees.

Given the time burden being a committee member places on an individual, TGA also allows people to offer their expertise on a more ad hoc basis. These specialist advisors are appointed on three-year terms, but their advice is only sought when TGA is addressing specific topics. There is no expectation for the advisors to attend a certain number of meetings a year, making it possible for them to fit their regulatory responsibilities in around their day jobs.

The statement to reveal the start of the search for experts makes no mention of specific scientific fields in which TGA is keen to improve its access to knowledge. Instead, the statement includes a long list of areas of expertise in medicines, medical devices, biologics, vaccines and other fields. The list is comprehensive and, as such, TGA is effectively seeking access to expertise in any topic that falls within its purview.

TGA Notice

India Postpones Another Committee Meeting in Response to Shortage of Experts

The Central Drugs Standard Control Organization (CDSCO) of India has postponed a subject expert committee in response to the “unavailability of experts,” the same reason it cited when canceling four subject expert committees in July.

A meeting of pulmonary experts is the latest to be affected. The committee was due to meet this week, but CDSCO has been forced to cancel the event. CDSCO intends to reschedule the meeting, although it is yet to set a date for the next meeting of the committee.

The decision to postpone the meeting comes two months after CDSCO took similar actions regarding four other gatherings of subject expert committees. Those earlier actions affected the analgesic and rheumatology, dermatology and allergy, endocrinology and neurology and psychiatry meetings.

CDSCO has said little beyond brief statements about the repeated postponements, but in May it put out a call for more people to join the subject expert committees. That request for experts covered 29 CDSCO committees, including those affected by postponements in recent months.

CDSCO Alert


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe