Asia Regulatory Roundup: CFDA Begins Overseas Inspections (26 January 2016)

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

CFDA Warns Indian, Japanese Manufacturers as Overseas Inspection Drive Begins

China Food and Drug Administration (CFDA) has found fault with the manufacturing practices of four foreign drugmakers, the highest profile of which is India’s Aurobindo Pharma. The regulator framed the warnings as part of an initiative to step up its oversight of companies that are importing products into China.

Aurobindo Pharma sits alongside Austria’s EVER Neuro Pharma, Italy’s Bruschettini Laboratories and a Japanese manufacturer on the list of companies affected by the initial wave of CFDA actions. Each is accused of failing to comply with some aspect of good manufacturing practices (GMPs), with the exception of Aurobindo Pharma, which was condemned for repeatedly delaying a visit by CFDA inspectors. Faced with the alleged stalling tactics, which echo those used by Chinese firms to frustrate overseas regulators, CFDA has decided it is unable to sign off on the quality of the Indian production plant.

The regulator has reached similar conclusions about the other plants, but for different reasons. At EVER Neuro Pharma, CFDA raised concerns about inconsistencies between the amino acids used in the production process and details of the composition of the product presented in the registration paperwork. Bruschettini Laboratories was accused of data integrity problems and failure to prevent the risk of cross-contamination, while CFDA took the Japanese manufacturer to task over its process validation activities and the completeness of its test results.

CFDA has ordered port officials to stop imports of products affected by its actions, which include a cephalosporin antibiotic manufactured by Aurobindo Pharma — which is in short supply in the United States — and a neurological drug sold by EVER Neuro Pharma. The registration status of some of the businesses has also been affected by the CFDA actions, which are an early indication of the desire of the regulator to go global with the more vigilant approach to GMPs it has established within China in recent years.

The plan is to strengthen the inspection of overseas production plants and take actions, ranging from recalls to import bans and beyond, against companies that are found to fall short of CFDA’s GMPs.

CFDA Notice (Chinese)

DCGI Calls for Industry Feedback on the Regulatory Burdens Holding Back Businesses

The Drug Controller General of India (DCGI) GN Singh has written to pharmaceutical trade groups to seek feedback on which regulatory processes are most burdensome to businesses. Singh initiated the data-gathering exercise to inform a government initiative to boost growth by making it easier to do business in India.

Manufacturing associations were encouraged to speak out on two topics in particular, both of which relate to the permissions that must be obtained to operate in India and how long it takes to receive such clearances. This is a long-standing concern in India, where companies have complained about the lengthy and inconsistent waits to receive paperwork from regulatory officials. DCGI thinks taking the regulatory machinery online will resolve some of the current shortcomings, but is also looking for other ways in which the process can be improved.

An article published in The Times of India this week highlighted what is at stake. The piece profiled the experience of Dr KM Cherian, a cardiac surgeon who set up a firm to manufacture heart valves in 2008. However, Cherian has made slow progress. The surgeon said it took four years to gain DCGI approval to conduct a Phase II trial. A request for clearance to house animals for R&D purposes at an Indian facility, which was initially made in 2013, is still outstanding. “This is why biotech companies and R&D facilities are locating elsewhere,” Cherian said.

Leading officials in the Indian government are keen to stop this from happening. However, as Cherian noted, while the government is publicly presenting itself as a red tape-cutting friend to business, aspects of the regulatory machinery are yet to get in sync with this approach. The Indian Drugs Manufacturers Association (IDMA) has spotted the same disconnect. Officials at the trade group are fighting back against plans by DCGI to increase the fees it charges for various registrations and licenses, including a proposed 10-fold jump in the charge for site inspections, PharmaBiz reports. 

DCGI Letter, The Times of India, PharmaBiz

CFDA Medical Device Agenda Targets Improved Internal Processes After Regulation-Heavy 2015

CFDA has outlined its agenda for the regulation of medical devices for the coming year. Having spent 2015 releasing a flurry of new guidance documents, the regulator’s attention is turning inward, with the reform of its approval system and bolstering of its IT and staffing capabilities on the to-do list.

Officials laid out their priorities at a conference in Beijing. The plan is built around five objectives, many of which look inward at CFDA capabilities and processes. CFDA is aiming to emerge from this year with a reformed approval process for medical devices. Improvements to the verification process for data from clinical trials of medical devices and the management of standards covering the sector are among the planned changes.

CFDA is looking at its own ability to carry out this agenda. The plan calls for CFDA outposts to build out their teams of reviewers and inspectors at a faster rate, while simultaneously putting education and training systems in place to ensure they have the long-term human resources to carry out the regulatory strategy. CFDA is planning to intensify its investment in information technology to support this work. Increased cooperation with foreign regulators is planned, too.

The internal activities are intended to build upon legislative work carried out by CFDA over the past 12 months, during which time it has adopted new medical device documents covering the naming of products, reporting of adverse events, oversight of quality and the product registration process. Continued implementation of these and other initiatives, notably cracking down on organizations that fail to meet the revised regulatory expectations, is part of the strategy for the coming year.

CFDA Notice

Drugmakers Pull Nearly 200 Applications in China in First Weeks of 2016

Another batch of drugmakers have pulled marketing applications in China. CFDA said the first three weeks of 2016 saw 128 companies pull 199 applications, adding to the more than 1,000 filings that were withdrawn last year in the wake of the regulator’s drive to weed out subpar clinical trial data.

Since CFDA told applicants to self-audit their clinical trial data and withdraw any filings that fell short of its standards, hundreds of companies have voluntarily abandoned their plans to seek approval on the basis of their existing datasets. Within days of the self-auditing deadline passing in August, CFDA said companies had pulled 317 filings. In the months since then, the regulator has periodically added to the list of companies that have withdrawn applications.

The spate of voluntary actions has helped CFDA to trim its backlog of applications, which had swelled to an estimated 20,000 filings at one point last year. CFDA Commissioner Bi Jingquan claims almost 10,000 applications were processed last year, around twice as many as over the previous 12-month period, as moves to get on top of the issue began to take effect. The self-audit campaign accounted for more than 1,000 filings. Actions to speed up CFDA’s reviews accounted for the rest.

CFDA Alert, FiercePharmaAsia