Asia Regulatory Roundup: India Allows Parallel Submission of Trial Filings for Insulins, mAbs (9 August 2016)

Posted 09 August 2016 | By Nick Paul Taylor 

Asia Regulatory Roundup: India Allows Parallel Submission of Trial Filings for Insulins, mAbs (9 August 2016)

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

DCGI Allows Parallel Submission of Clinical Trial Filings for Insulins, mAbs

The Drug Controller General of India (DCGI) has cleared clinical trial sponsors to submit applications to his office and the Review Committee on Genetic Manipulation (RCGM) simultaneously. By moving from sequential to parallel filings, DCGI has potentially shortened the time it takes for developers of insulins, monoclonal antibodies and certain other products to secure clearance to run clinical trials.

Prior to the adoption of the parallel process, developers of drugs under the supervision of RCGM had to get approval to start a clinical trial from that committee before making a submission to DCGI. Now, DCGI Dr. GN Singh has tweaked the workflow to allow drug developers to make simultaneous submissions. The new model has the potential to shorten the time it takes to gain regulatory clearances for clinical trials, although perhaps not by as much as some people would have hoped. DCGI will only start reviewing a submission once RCGM has signed off on the study.

That stipulation means companies that have to go through RCGM will still have to wait longer than developers of drugs outside the scope of the committee to receive approvals. RCGM’s authority covers recombinant DNA derived drugs, a classification that includes major groups of products such as insulins and monoclonal antibodies (mAbs). Given the scale of clinical development activity involving insulins and mAbs, even a slight shortening of average clinical trial approval timelines could amount to sizable cumulative time savings across the sector as a whole.

DCGI unveiled the change on the same day as another circular regarding clinical trial regulations. The second update freed clinical trial sponsors from the need to obtain a no objection certificate (NOC) from DCGI every time they add a site or investigator to a study. Under the new approach, sponsors can go through ethics committees when they need to add a site or investigator, although DCGI wants to be kept abreast of such changes. “If no objection was received from DCGI, it would be deemed to have concurrence of [Central Drugs Standard Control Organization],” Singh wrote.

Singh published the two circulars the day after releasing two other documents related to clinical trial regulations. Collectively, the four circulars represent an attempt make regulations in India amenable to the efficient conduct of clinical trials.

DCGI Circular, More

CFDA Awards Contract for Development of Regulatory Data Sharing Platform

China Food and Drug Administration (CFDA) has tasked AsiaInfo Technologies with the development of a regulatory data sharing platform. CFDA is presenting the platform as a way to move regulatory interactions online, a step many of its global regulatory peers have taken in recent years.

In its brief description of the planned features of the regulatory platform, CFDA used terms such as “data sharing,” “business collaboration services” and “exchange services.” A fuller description of the platform is yet to emerge, but these terms suggest the platform will allow CFDA and the businesses it regulates to conduct a greater proportion of interactions online. Other regulators, notably India’s CDSCO, see the move to online interactions making processes more transparent and consistent.

CFDA framed its decision to set up the platform as part of a strategy initiated by the government in its latest Five Year Plan. The strategy is called the “innovative, coordinated, green, open and shared development model,” a broad term that has made its revised way of thinking applicable to a wide range of industries and organizations, including CFDA. Faced with this pressure from the government, CFDA put the platform plan out to tender.

AsiaInfo, a 23-year-old telecommunications and IT company, has won the contract and will receive RMB 360,000 ($54,000) to develop the platform, something CFDA anticipates will take five months. CFDA is yet to release guidance outlining how the implementation of the platform will affect the companies it regulates.

CFDA Notice (Chinese)

CDSCO Extends Online Portal to Cover Clinical Trial Applications

CDSCO is extending its Sugam online portal to cover clinical trial applications. The regulator is helping the industry prepare for the latest step in its phased rollout of the platform by holding a meeting to demonstrate how it works and gather feedback on how this fits into clinical trial submissions.

In keeping with the approach it has pursued throughout the history of Sugam, CDSCO is gathering the clinical trial industry in New Delhi this week to discuss the expansion of the platform. CDSCO wants to use the meeting to perform a live demonstration of Sugam and gather feedback from attendees. This process should be getting easier as many of the groups invited to the meeting, such as India’s Association of Clinical Research Organisation (ACRO), were also asked to attend earlier sessions.

Having refined Sugam in response to feedback from groups such as ACRO over the past year, CDSCO has gained the confidence to expand use of the platform. The question at this stage is whether the system fits with the needs of the clinical trial sector. At a time when CDSCO is revising its policies to make India a more attractive location to conduct clinical trials, the regulator can ill afford to botch the implementation of Sugam.  

Over the past few months, CDSCO has worked to prepare the portal to handle submissions related to bioavailability and bioequivalence NOCs, ethics committee registrations and the cosmetics industry. Those steps continued a process of expanding the use of the system that began in November with the introduction of its use for requests to register and import drugs. The addition of clinical trial applications to Sugam will mark another big step forward.

CDSCO Notice

TGA Posts Guidance on Online Applications for Registered Complementary Medicines

The Therapeutic Goods Administration (TGA) of Australia has posted guidance to support users of its online form for registered complementary medicines. TGA’s guidance gives a thorough overview of how to use its online form, going as far as to explain how drop-down lists and checkboxes work.

Regulatory processes relating to manufacturers of registered complementary medicines were moved online by TGA last year. At that time, TGA released a 10-page guidance document to walk companies through the process of applying for a new registered complementary medicine or to make changes to an existing product using the system. Now, TGA has released a more extensive online explainer that covers everything from gaining access to the portal to handling invoices. 

TGA has carried over some of the sections from its earlier document, but has also added new pieces of text and additional screengrabs. The result is series of web pages that appear designed to ensure a person with no prior experience of filling in online forms, in any context, can work their way through the process without assistance other than the guidance.

TGA Guidance

Other News:

CDSCO has revised its list of drug inspectors who are being reassigned. The list supersedes another document CDSCO released late last month. Notable changes include a reduction in the number of inspectors being reassigned, from 40 to 34. The changes amount to an even larger net loss in drug inspectors for CDSCO’s headquarters. CDSCO Notice

CFDA has released a document relating to reagents used in in vitro diagnostics. The regulator has dealt with such reagents separately from other medical devices in revising its regulations.  CFDA Alert (Chinese)

Categories: Regulatory News

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