Asia Regulatory Roundup: CFDA Continues Medical Device Quality Drive (27 October 2015)

Posted 27 October 2015 By Nick Paul Taylor

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

CFDA Continues Medical Device Quality Drive

China Food and Drug Administration (CFDA) has released another document about the quality of medical devices. The regulator's latest missive moves its focus further down the supply chain to address quality aspects of the procurement, storage, use and maintenance of medical devices.

CFDA has published the document to address what it sees as shortcomings in how medical devices are handled as they leave the factory and enter the final steps of the healthcare supply chain. In a notice to accompany the document, CFDA highlights the lack of standardized procurement channels for medical devices, the failure to inspect purchases and the lax approach to maintenance as issues with the current system.

Officials at CFDA are aiming to improve the system by changing how the industry approaches several steps in the supply chain. The new guidance calls for buyers of medical devices to thoroughly inspect supplier qualifications and product documentation while also maintaining records of their activities. Once a device is acquired, CFDA wants healthcare providers to ensure it continues to work as intended by implementing a maintenance program.

The release of the medical device management document comes weeks after CFDA published four sets of guidelines about medical device good manufacturing practices (GMPs) and its approach to on-site inspections. In the past year, CFDA has also committed to performing surprise inspections of medical device manufacturers and updated the GMP regulations that cover the industry. The latest procurement and storage-focused document is set to come into force on 1 February 2016.

CFDA Notice, More (Chinese)

Australia Extends Comment Period on Plan to Protect Biological Patentability

The Australian Patent Office has extended the deadline for comments on the proposals it made in the wake of the High Court's ruling against Myriad. Officials are looking to use the ruling as the basis for a policy setting out the types of biological materials that are eligible for patent protection.

Myriad lost its case in Australia because the High Court decided the basis for the invention was the information found in nucleotides, not human action. Yet while the decision was a setback for Myriad, it could make the patent situation clearer for other companies. With the High Court ruling that information coding for a polypeptide is ineligible for patent protection, Australia has proposed adding it to a short list of biological materials for which it will not accept intellectual property claims.

Naturally occurring nucleic acid sequences, from humans and other species, that code for functional fragments of polypeptides or the full molecules sit alongside cDNA and coding RNA on the list of materials that are ineligible for patent protection. While this proposal, if it comes into force, would mean a lot of genetic material is unpatentable, it also leaves considerable scope for protecting the intellectual property of biological substances.

The proposal lists isolated regulatory and non-coding DNA as being eligible for patent protection. Materials other than DNA and RNA are also covered by the proposal. Isolated bacteria, viruses, polypeptides, polyclonal antibodies, cells and stem cells are all eligible for patent protection under the plan, as are probes, primers and chimeric nucleic acids. Australia had planned to close the comment period on the proposal on 30 October, but is now keeping it open for another week.

Statement, The National Law Review, More

China Starts Coordinated Clampdown on Illegal Sodium Hyaluronic Injections

CFDA has joined with four other government departments to clamp down on the illegal production and sale of sodium hyaluronic injections. The coordinated action is intended to curb the unlicensed use of sodium hyaluronic injections as a skincare treatment by beauty salons.

Officials at CFDA are coordinating the program and using their own resources to tackle the problem at its source. The regulator is calling on its units to intensify inspections of producers of sodium hyaluronic injections with a view to prosecuting any companies found to be manufacturing the product without obtaining the necessary clearances. Stemming the supply of the injections is the first step in a multi-part strategy designed to dent the use of the products by March 2016.

CFDA is working with other government departments on the rest of the strategy. The Ministry of Industry and Information Technology, the Ministry of Public Security, the National Health and Family Planning Commission and the State Administration for Industry and Commerce are all involved with the campaign. China has brought together this diverse range of government departments in an attempt to tackle the different facets of the illegal supply and sale of sodium hyaluronic injections.

The health department will strengthen oversight of beauty salons to root out institutions involved with the illegal use of sodium hyaluronic injections, while communication authorities will go online in search of promotion of banned skincare services. China thinks it can affect the illegal industry quickly. The plan is to enter the consolidation phase of the campaign in March 2016, by which time China is hoping months of more stringent supervision will have eliminated some of the illegal market.

CFDA Notice (Chinese), Xinhua

Taiwan FDA Pushes Industry Toward GDP Compliance

The Taiwan Food and Drug Administration (TFDA) has posted a notice about the phased rollout of good distribution practice (GDP) requirements. TFDA expects the pharmaceutical industry to have fully implemented GDPs by the end of 2018.

Officials in Taiwan have spent several years communicating the importance of GDPs to the industry, as well as explaining how to implement the requirements, at seminars, training courses and other events. The education campaign is part of TFDA's attempts to bring the companies it regulates up to international standards, an initiative that gained renewed impetus in 2013 when Taiwan joined the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).

PIC/S has revised its approach to GDPs in recent years, notably by adopting a document based on European Union guidelines in 2014, and TFDA is trying to ensure domestic manufacturers keep pace. The regulator views the standards-raising drive as a way to give consumers confidence in the quality of the medicines they take at a time when counterfeit and substandard products are a worry.

TFDA Notice (Chinese)

Other News:

The move to allow online sales of prescription drugs in China has reportedly stalled. In May 2014, the Ministry of Commerce outlined its plans and China looked set to open up the market. Since then, nothing has happened officially. The pause is reportedly the result of the pharmaceutical industry and hospitals lobbying against online drug sales. China Medical News

The Malaysian National Pharmaceutical Control Bureau is reporting it has brought its online filing system back online. Users were struggling to access the system through a link on the regulator's web portal, an issue officials say can be resolved by clearing the browsing history and restarting the computer. The regulator also recommends using older versions of Internet Explorer. NPCB Notice

The Tamil Nadu Drugs Control Administration (TNDCA) is trying to persuade the government to support the construction of one analytical laboratory and three assistant drug controller offices. The state regulator is also hoping to hire 64 drug inspectors, a recruitment surge that would represent a 44% increase on its current headcount. PharmaBiz

Boehringer Ingelheim was denied a patent by the Indian Patent Office. The Economic Times

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Distribution, Government affairs, Regulatory strategy, News, Japan, China, Taiwan, Korea, India, Asean, Oceania, MHLW, CFDA, MFDS, CDSCO, TGA

Tags: Regulatory Roundup, Asia Regulatory Roundup

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