Asia Regulatory Roundup: CFDA Offers Technical Guidance on Clinical Trials (24 January 2017)

Regulatory NewsRegulatory News | 24 January 2017 |  By 

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

CFDA Posts Comprehensive Technical Guidance on Clinical Trials

China Food and Drug Administration (CFDA) has released technical guidance on clinical trials, walking drug developers through the entire clinical research process, from preparing to run a first-in-human trial to designing post-marketing and pharmacogenomic studies.

CFDA has created the document to provide companies and researchers with guiding principles as they set about designing R&D strategies and running individual studies. The text starts with fundamentals, such as the need to adhere to the ethical principles set out in the Declaration of Helsinki, before delving into the considerations and processes that go into designing and running different types of clinical trials.

Specific points covered in the document include definitions of exploratory and pivotal clinical trials, and an explanation of the decision-making process used to go from one to the other. CFDA goes on to provide more advanced information, such as the selection of primary endpoints and the use of intention-to-treat statistical analyses.  

In drafting a comprehensive, ground-up overview of the drug development, CFDA has effectively provided a how-to guide for clinical trial sponsors. Experienced R&D leaders and trial investigators will know most, if not all, of the points made in the document already. Yet, given the emerging, fast-growing nature of the clinical trial sector in China — and its periodic problems with fraud and low study standards — the document could provide a useful grounding for other researchers. 

Publication of the how-to guide to clinical trials follows a period in which CFDA has tried to raise the standards of studies and the data they generate. The campaign has seen CFDA try to remove filings based on substandard studies from its backlog and post draft guidance on data integrity in clinical research.  

CFDA Notice (Chinese)

India Proposes Scrapping Import License Form, Simplifying Clinical Trial Filings

India is proposing to simplify the process of applying to import a drug or run a clinical trial. The planned changes to the Drugs and Cosmetics Act, 1940, would eliminate an import license form and cut a section from the clinical trial application.

The change to the process of applying for an import license is the more substantial of the two proposals. If enacted, the legislative amendment would eliminate Form 9, one of the documents organizations currently have to complete and submit to receive a license. The form is a declaration of the applicant’s commitment to comply with regulations and keep officials informed of a change to the location where the drug is manufactured.

Currently, import applicants submit Form 9 alongside either Form 8 or 8A, depending on whether the drug is part of Schedule X. The proposal is to remove references to Form 9 from the other two documents and make them the main texts applicants need to submit when seeking an import license.

The proposal was released alongside another planned amendment that affects Form 44, a document used in applications to run clinical trials, import products and manufacture drugs. The plan is to simplify Form 44 by removing a section that requires applicants to list details of the patent status of the drug.

Together, the proposals fit in with India’s ongoing attempt to reduce the bureaucratic burden of doing business in the country. 

Officials at the Ministry of Health and Family Welfare proposed the changes in notifications in The Gazette of India, the official record of government notices. The industry has 45 days to share any objections or comments with the officials.   

Import Rules, Trial Rules

DTAB Backs Plan to Rebrand CDSCO as Indian Drugs Administration

The Drugs Technical Advisory Board (DTAB) of India has backed a plan to rebrand the Central Drugs Standard Control Organization (CDSCO). DTAB’s recommendation moves the proposal to rename CDSCO as the Indian Drugs Administration (IDA) a step closer to coming into force.

Reports of a planned rebranding first emerged in 2015. At that time, the Ministry of Health and Family Welfare told other wings of government of its interest in rebranding CDSCO as the Central Drugs Administration. The idea was framed as part of a strategy to make India’s regulator more like the United States Food and Drug Administration.

Now, 18 months later, a slightly reworked proposal has reached DTAB, a committee that advises the Drug Controller General of India (DCGI) Dr. GN Singh. DCGI Singh sits on DTAB as its member secretary and raised the proposed name change at a meeting of the board earlier this month. The minutes of the meeting are brief, noting only that Singh said the change would “make it simple and befitting to its activities.” After deliberating, DTAB recommended the proposal.

The full implications of the proposed change are unclear, but some observers see it as a significant event.

“Now the IDA will lay the foundation for qualified pharmacy professionals and this will automatically spur rapid license approvals in a transparent and efficient manner,” Dr. BR Jagashetty, former national adviser, drugs control, told Pharmabiz.

DTAB considered the rebranding at a meeting that also looked at whether to waive the need to run clinical trials of drugs that are already approved in International Conference on Harmonisation countries. The board is in favor of waiving studies, provided CDSCO inspects the production plant and other conditions are met.

Meeting Minutes, Pharmabiz

TGA Reduces Number of Advisory Committees

The Therapeutic Goods Administration (TGA) of Australia has reduced its number of advisory committees from 11 to seven. TGA took the action as part of the Smaller Government Agenda that seeks to shrink public office by closing and merging functions.

As part of the changes, which came into force at the start of the year, TGA has introduced the Advisory Committee on Medicines (ACM) to cover work previously handled by three other committees. The committee replaces now-defunct groups that looked at prescription drugs, over-the-counter products and the safety of medicines.

Some of the prescription drug work is now handled by the Advisory Committee on Vaccines, which is also replacing an old vaccine safety-focused group.

The changes also include the scrapping of the Therapeutic Goods Committee and merging of a medical device safety group into a larger, less-specialized board.

Government officials proposed the changes after reviewing the recommendations of the expert review they commissioned. However, the changes were not proposed by the expert review. The review called for the Advisory Committee on Medicines Scheduling to be made a subcommittee of ACM. That proposal was rejected as “the roles of medicine consideration for TGA registration and for scheduling are quite different,” but it led to the proposal to reduce the number of committees. 

TGA Statement

Other News:

DCGI Singh has informed the industry of a change to the clinical trial waiver process in India. Now, instead of having the Technical Committee and Apex Committee rule on whether to waive a trial, the Central Licensing Authority will make the decision. The Technical Committee will step in to make the final decision if there is a dispute. DCGI Note

TGA has provided an update on the long-running disruption to the supply of extended-release metformin. One brand is now classed as “available,” having previously been in limited supply. However, four products that came back onto the market in September are in short supply again. TGA also added a new product to the list of brands with limited availability. TGA Notice



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