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Regulatory News | 28 June 2016 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
India has released draft legislation about medical devices. The text defines different types of medical devices, categorizes them by risk and establishes a registration process for all except the products that pose the least threat to users.
Officials are proposing to break medical devices and in vitro diagnostics up into four groups, ranging from Class A to Class D. Class A devices and diagnostics are those deemed to be very low risk. India is planning to categorize various noninvasive devices, reusable surgical instruments and other products as Class A. Devices with this status do not need to be licensed. As such, this sector of the medical device industry can continue to regulate itself as it does today.
The proposed situation for higher-risk devices is different. Medical devices that incorporate human cells, long-term implants and other products seen as posing greater risks to patients will have to be licensed by regulatory authorities if the draft legislation comes into law. Currently, India only requires the manufacturers of 22 types of medical devices to go through the registration process. The new law would extend these requirements to the wider medical device industry.
Officials are proposing to give manufacturers of medical devices that are already on the market, but were never registered, 90 days to apply for a license. The licensing application must include evidence of a previous sale of the product in India. This process and other regulatory actions will carry a fee, but the section of the legislation that will provide further details on this topic currently only features the text "to be decided later."
While the government has yet to clarify its intentions with regard to fees, it has provided lots of detail on other aspects of its plans for regulation of medical devices. The 146-page document covers the process for clinical development of medical devices, provides a master file template for firms and outlines the duties and functions of the notified bodies that will be tasked with auditing companies and other tasks.
These audits will entail on-site inspections of companies' quality management systems, reviews of technical documents and other tasks designed to ensure medical devices are safe, effective and compliant with standards. If an audit identifies "major" noncompliance issues, the notified body will give the manufacturer "reasonable time" to rectify the situation. Once this time has passed, an audit will be performed to verify the compliance of the company.
While the text applies regulations to the medical device industry, it also addresses many concerns the sector has raised with the government in recent years. Speaking to PharmaBiz when news of the legislation leaked, Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry, said: "We are elated by this decision. This strategic move will certainly open huge market opportunity, as it will finally be a viable and profitable decision to invest in India."
Prior to the publication of the draft medical device legislation, the Indian government withdrew the Drugs and Cosmetics (Amendment) Bill, 2013. That earlier draft legislation covered medical devices, too, but was deemed inadequate at addressing the needs of the sector. Specifically, officials felt a new text was needed to "facilitate the ease of doing business" and "substantially" enhance the quality and efficacy of products sold in India.
Draft Legislation, PharmaBiz, Government Notice
China Food and Drug Administration (CFDA) has released draft regulations regarding priority approval of medical devices for consultation. The text defines the types of medical device that will be eligible for the program and sets timelines for certain regulatory processes in the priority approval pathway.
CFDA has drafted the regulations to fast track the approval of devices that cater to an unmet need, such as those that diagnose or treat rare diseases or cancer and have obvious clinical advantages over existing products. The pathway is also open to products that diagnose or treat diseases affecting the elderly or children for which there are currently no effective options. CFDA has created a priority review request form companies can use to explain why their devices should be given special treatment.
Officials are proposing to review applications within five working days and are giving the industry 10 days to submit objections to its decisions. Devices that are accepted into the program will enjoy a range of benefits. CFDA is instructing its staff to prioritize the processing of technical reviews, registration assessments and other regulatory tasks relating to medical devices on the program. Officials are also expected to actively communicate with manufacturers with priority review status.
The process, from the types of devices that are eligible for the program through to the benefits they receive, is reminiscent of the priority review pathway CFDA created for drugs earlier this year. That program is aimed at drugs that treat cancer, rare diseases, AIDS, tuberculosis and viral hepatitis, as well as conditions affecting children and the elderly. CFDA accepted drugs from AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Gilead and Janssen Pharmaceuticals onto the program in April.
CFDA Notice (Chinese)
CFDA has threatened to take action against the 370 drug wholesalers that failed to comply with its request that companies in the sector self-audit their operations. While the deadline has passed, CFDA is proposing to be more lenient on companies that belatedly act on its self-audit demands.
The majority of the industry complied with the original self-audit request. CFDA knows of 12,480 pharmaceutical wholesale enterprises. Of these, 370 have simply failed to submit self-audit reports as requested by CFDA. A further 75 have asked CFDA to cancel their licenses, an action that frees them from the need to submit a self-audit report or make their operations compliant with regulatory expectations.
CFDA is now focusing its attentions on the 370 companies that failed to comply with its request, while continuing to apply pressure to the rest of the sector. The regulator released a list of all of the companies that have not submitted reports, but is yet to provide details of what it will do to organizations that continue to fail to comply and run their drug wholesaling businesses. CFDA has said punishments will be severe, though.
The regulator has also demanded that companies that filed self-audit reports continue to assess their operations. Officials think some companies, while complying with its self-audit request, are being evasive. The regulator is promising to be more lenient on companies that identify and report issues at their operations. CFDA is ordering its regional units to organize inspections of wholesalers. Surprise inspections are part of the proposed oversight program.
The Drug Regulatory Authority of Pakistan (DRAP) has reportedly rejected registration applications from 4,500 manufacturers of herbal products. DRAP received 10,000 submissions from local and overseas companies. The regulator has ruled that almost half of the filings contain incomplete documentation. Approximately 300 licenses have been issued to date. Pakistan Observer
The former Karnataka Drugs Controller has called on Indian regulators to establish rules for online pharmacies as soon as possible. The demand follows shortly after an online pharmacy trade group criticized regulators for failing to clarify guidelines covering the sector and taking excessive actions against transgressors. PharmaBiz
Tags: Regulatory Roundup, Asia Regulatory Roundup