Asia Regulatory Roundup: AHWP to Harmonize Device Submissions in Asia (10 November 2015)

AHWP Releases Guidance on Harmonizing Medical Device Submissions in Asia

The Asian Harmonization Working Party (AHWP) has posted guidance on the preparation of a common submission dossier template for the region. AHWP views the guidance as a step toward eliminating the need for medical device manufacturers to create individually formatted dossiers for submission in China, India and its other member countries.

As it stands, companies pursuing the approval of medical devices in multiple Asian countries have to prepare different dossiers to each national regulatory body. The differences between the dossiers are primarily to do with formatting, not content, and as such AHWP sees value in harmonizing styles. As well as China and India, regulators from Hong Kong, Singapore, Korea and 19 other countries, including some such as South Africa that are located outside Asia, are members of AHWP.

In the guidance proposed by AHWP, the working group sets out its vision for a Common Submission Dossier Template (CSDT), from the definitions that underpin its approach through to specifics of how to present the device description and features. The CSDT is designed to present all the information that is needed to comply with the essential principles of medical device safety and performance that were established by the Global Harmonization Task Force (GHTF) in 2012.

The focus on meeting the needs of existing requirements, rather than creating new ones, means the adoption of AHWP’s proposed CSDT should not place additional burdens on manufacturers. Instead, the ability to base medical device filings to 24 regulatory agencies, including some that represent big markets, on the CDST should simplify the process of pursuing approvals across Asia. The document is one of 13 proposed final texts that were up for endorsement by AHWP at its meeting this week.

AHWP Guidance, Other Documents

China Fleshes Out New Approach to Medical Device Quality

The China Food and Drug Administration (CFDA) has released another batch of documents about its new approach to the regulation of medical devices. The documents include a revision to CFDA’s handling of medical device registration and a Q&A on how to interpret the update, plus further details of its inspection priorities.

Collectively, the documents provide additional details about what medical device developers and manufacturers can expect now that CFDA has overhauled its documents covering their industry. CFDA established a new approach to the registration of medical devices and in-vitro diagnostics more than one year ago, well before the recent spate of guidance documents, and has now decided it needs to take steps to further the implementation of the agenda it put in place in October 2014.

The regulator has set out its latest thinking on medical device registration in eight bullet points, which detail the effect of its mandatory standards on the process and what information about the clinical evaluation of a product should be submitted. CFDA has also published a short Q&A document designed to help companies interpret its medical device registration regulations. The Q&A explains the purpose of medical device registration and details aspects of CFDA’s approach to the topic.

CFDA has also published a follow up to its earlier documents on the changing nature of inspections of medical device manufacturing plants in China. The latest text covers how inspection bodies should organize themselves in light of the changing nature of medical device oversight in China. CFDA goes into detail about the experience and knowhow inspectors must possess, such as knowledge of medical device regulations, laboratory safety and data processing. 

Q&A, Inspection Notice, More (Chinese)

TGA Posts Warning About Counterfeit Drugs and Devices

The Australian Therapeutic Goods Administration (TGA) has posted a warning about counterfeit drugs and medical devices. In the warning, which is an update to advice first offered by TGA in 2011, the regulator details the risks associated with fakes, the types of products that are counterfeited and provides a case study about the use of sibutramine in illegal weight loss medicines.

TGA has made some notable changes to the warning since it last revised the text in 2011. The latest advice emphasizes the risks counterfeit medical products pose to human health and the lack of TGA oversight of the quality of fake drugs. TGA has also expanded its list of the risks associated with fake drugs and devices. The danger of using devices with substandard components and drugs that contain ingredients that were pulled from the market for safety reasons are new additions to the list.

The latter of these warnings is a direct reference to the case study cited by TGA in its warning, in which the regulator discusses the use of sibutramine in weight loss medicines. Sibutramine, the active ingredient in the diet drug sold by Abbott Laboratories as Merida, was withdrawn from the market in Australia and other countries in 2010 amid concerns that it increases the risk of heart attack and stroke. Despite this, TGA continues to find the ingredient in counterfeit products.

Lifestyle drugs such as Merida were the primary concern of TGA when it issued a warning about fake medicines in 2011, but the regulator’s latest warning gives equal prominence to over-the-counter products and treatments for diseases such as cancer and AIDS.  

TGA Notice

Taiwan Implements Two-Step Medical Device Review Program

The Taiwan Food and Drug Administration (TFDA) has formally moved to a two-step process for the review of medical devices. Having brought the policy into force on 10 November, TFDA will now carry out administrative reviews of applications before starting on technical aspects of the process.

Under the old model, TFDA would sometimes review administrative and technical aspects of filings in parallel. Companies could file for approval without first acquiring Quality System Documentation (QSD) approval letters, a process that can take six months. However, TFDA now wants companies to include QSD approval letters in the documentation that is submitted for the administrative review. Once this step is completed, TFDA will then review testing data and other technical details.

TFDA is aiming to carry out the administrative review within 10 days of receiving the documents. If this timeline is adhered to, the move from a parallel to concurrent model of review should have little detrimental impact on how long it takes TFDA to process applications. However, the need to include a QSD approval letter in the filing for administrative review could set companies back. TFDA also wants to see application forms, authorization letters and certificates of free sale at this stage.

TFDA Notice (Chinese), MassDevice

Other News:

Members of the World Trade Organization (WTO) have agreed to continue exempting the poorest countries in the group from aspects of the TRIPS Agreement. The exemption frees the countries to choose whether to protect the patents of pharmaceutical products. WTO has now extended this right through to at least 2033. Press Release

The Drug Regulatory Authority of Pakistan (DRAP) has rejected the registrations of around half of the companies that have submitted applications. DRAP has reportedly knocked back at least 2,000 of the 4,000 companies that have approached it, theoretically limiting supplies of 36,500 products. However, many companies have continued operating despite being unregistered. The Nation

Attempts by the Central Drugs Standard Control Organization (CDSCO) to expand are being held back by difficulties sourcing land for a new office. The New Indian Express