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Posted 23 August 2016 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China Food and Drug Administration (CFDA) has released revised draft guidance on preclinical studies for consultation. The text sets out CFDA’s expectations for the gamut of factors that go into running preclinical studies, from the skills and responsibilities of laboratory staff to the design of facilities.
CFDA established its position on the conduct of preclinical tests in 2003, before going on to introduce texts relating to good laboratory practices (GLPs) in the years that followed. The draft guidance posted this week represents a notable update to the 2003 document. CFDA has expanded multiple sections of the guidance and, in doing so, has provided extra details about its demands, clarified the penalty for failing to comply and brought the processes discussed in line with advances in science and technology.
In terms of penalties, CFDA has added several paragraphs to a section on supervision and inspection. Whereas the 2003 document just said CFDA was responsible for organizing inspections of preclinical laboratories, the draft text features three additional articles that dictate what happens to sites that fail to meet regulatory standards. The new articles outline CFDA’s expectation that noncompliant labs will carry out corrective actions and state how a failure to observe the rules can affect registration applications.
These additions are in keeping with the evolution of CFDA’s attitude to quality over the past decade. Other revisions have less to do with CFDA and more to do with broader shifts in how preclinical tests are run. The draft tasks preclinical testing facilities with establishing computer file storage systems that prevent unauthorized access and minimize the threat of viruses. CFDA also wants to see a full audit trail and electronic signatures. The term “audit trail” is absent from the 2003 draft, which, as a whole, is light on references to computer systems.
CFDA has also added sections on lower-tech threats to the records kept by preclinical facilities. The new text tasks facilities with establishing disaster safeguards to protect records from fire, water, insects, mice, power outages and other threats. A raft of other sections have undergone minor and major changes, resulting in the document representing a revised regulatory outlook on everything from the people employed at preclinical facilities to the standard operating procedures that guide their work.
CFDA is accepting feedback on the draft until 18 October.
CFDA Notice (Chinese)
The Therapeutic Goods Administration (TGA) of Australia has posted forms for changing the sponsor of a therapeutic product and an accompanying question and answer document. TGA has released the documents to help organizations deal with the variety of situations that necessitate a change to the sponsor of a product.
Across the multiple pages added to the TGA website in recent days, the regulator lays out how to go about changing sponsor details in the event of liquidation, acquisition or rebranding. For each of the scenarios, TGA has created a form that walks people through the information they must provide to support the transfer of sponsorship of a therapeutic product. TGA does not charge a fee for changing sponsor, regardless of the circumstances. The forms allow for the transfer of sponsorship for multiple products through a single application to TGA.
TGA has supplemented these forms with pages to help new sponsors understand their obligations and answer some common questions. The page on obligations points sponsors to the various pieces of legislation they have to comply with and the annual charges they have to pay. TGA also highlights the need to transfer or renew good manufacturing practice clearances and promptly inform its staff of changes to the details of the person handling pharmacovigilance. The page also covers record keeping, outstanding annual charges and other topics.
Finally, TGA has published a 10-point question and answer page. The list clarifies that sponsors are only to alert TGA of a transfer of ownership after it has happened, and that the regulator is powerless to reject the handover. TGA has more power in other areas. The question and answer page clarifies that former sponsors who continue to supply products after transferring ownership risk breaching the Therapeutic Goods Act. This is true regardless of whether the products were in stock at the time of the transfer.
The Joint Drugs Controller of India Dr. VG Somani has scheduled a training session for organizations involved in clinical trials. Somani arranged the gathering as part of the ongoing effort to ensure the clinical trial sector is prepared for the transition to the online regulatory portal Sugam.
At the five-hour event, set for 24 August, officials from the Central Drugs Standard Control Organization (CDSCO) will show attendees how to use the portal to apply for no objection certificates (NOCs). In a letter to inform the industry of the event, Somani included a portal username and password so prospective attendees, or anyone else, can play with the system before the training session. Somani is asking participants to arrive on the day with soft copies of clinical trial application documents.
The demand that attendees bring the documents, and may be denied access if they arrive without them, is one of several ways the training session and letter to announce it differ from those that have occurred before. CDSCO has held training events throughout the staged rollout of the portal, but these have lacked the demands placed on participants, release of a test username and password and prerelease of supporting documents that characterize the clinical trial session.
A smooth transition of clinical trial regulatory processes onto the online platform would represent a boost to CDSCO’s rollout plans. CDSCO introduced the portal nine months ago, at which time its use was limited to requests to register and import drugs. Since then, CDSCO has added regulatory processes related to bioavailability and bioequivalence NOCs, ethics committee registrations and the cosmetics industry to the platform.
A senior Chinese politician is publicly pressuring CFDA to accelerate its reform program and enhance the capabilities of its workforce. Vice Premier Wang Yang made the comments in an article in state media organization Xinhua that CFDA published on its website.
Wang is one of the most outspoken advocates for economic and political reform among China’s elite, and is now applying this modernizing ethos to CFDA. The article is light on the specifics of how Wang wants CFDA to change, but gives a broad overview of the areas in which he sees a need for reform. Many of Wang’s views echo other political discussions of CFDA.
The vice premier wants to see CFDA make better use of information technology to make supervision of the food and drug industries more efficient. If CFDA can achieve such efficiencies, it could close the gap between its resources and the size of the industries it regulates. Wang’s call for CFDA to involve the public and media more in supervision could also help in this regard.
Wang has also added his voice to the clamor for CFDA to build a more highly skilled and effective workforce. CFDA’s roadmap through to 2020 features multiple policies designed with this goal in mind.
CFDA Alert (Chinese)
Tags: Asia Regulatory Roundup, preclinical guidance, CFDA reforms