Asia Regulatory Roundup: China to Strengthen Oversight of Medical Device Manufacturing (13 October 2015)

Posted 13 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 Details New Approach to Medical Device GMP in Four Guidance Documents

China Food and Drug Administration (CFDA) has moved to strengthen its oversight of medical device manufacturing. The new approach is detailed in four guidance documents covering medical device good manufacturing practices (GMPs), in which CFDA explains its approach to on-site inspections.

CFDA has released the guidance documents to help the regulatory departments of medical device manufacturers bring their operations in line with the expectations of its inspectors. The documents, all of which are focused on on-site inspections, are targeted at different niches of the medical device industry. One of the documents covers the overall sector, while the other three focus in on the unique requirements of in-vitro diagnostics and sterile and implantable medical devices.

The general document covers the organizational composition CFDA recommends medical device firms adopt, including the relationship between production and quality teams. CFDA also details the role of responsible persons within the operation. The regulator sees such individuals taking charge of the quality policy and objectives of the organization. This entails checking the human resources and infrastructure are in place to run an operation that complies with China’s laws and regulations.

Publication of the guidance document continues a busy period for the medical device team at CFDA. In June, CFDA detailed plans to start surprise inspections of medical device manufacturers. Quality management systems are a primary target of the unannounced-inspection regime. CFDA has also revised regulations covering the sector. The big changes came to light late last year when CFDA set out its updated GMPs for medical devices.

CFDA Notice, More (Chinese)

TGA Provides Advice on Advertising Health Services Without Violating Drug Law

Australia’s Therapeutic Goods Administration (TGA) has released advice on how providers of health services that involve prescription drugs can advertise without violating regulations. The basic idea is to focus on the service itself and make no mention of the drug used in the process.

Providers of cosmetic services in the United Kingdom are chastised frequently by MHRA for referring to Botox in their advertising, and the TGA advice looks designed to avoid similar situations. TGA is clear about what companies cannot do. “If you reference specific therapeutic goods (or types of therapeutic goods), that are used in a course of treatment, the information could be considered promotional, and therefore is an advertisement for therapeutic goods,” the regulator said.

Healthcare professionals can also run afoul of the legislation. If a healthcare professional provides advice or information about treatments involving specific prescription products on their website, the text could violate the advertising terms of the Therapeutic Goods Act 1989. The penalties for such violations can total $7,880 (AU$10,800) for individuals and $39,400 for corporations, but TGA views these actions as a last resort.

“In the first instance, the TGA seeks to inform, educate and assist advertisers to comply with the rules relating to advertising. However, if this approach fails, we may take further action to achieve compliance,” the regulator said.

TGA Advice

India Extends Deadline for Compliance with Marketing Code

India has once again pushed back the target date for voluntary compliance with the Uniform Code of Pharmaceuticals Marketing Practices (UCPMP). Officials originally wanted companies to comply by the end of June, but have now given them until the end of the year to bring their operations in line with the code.

The delays, first by two months and now by a further four months, are indicative of the problems the Indian Department of Pharmaceuticals (DoP) has faced in trying to encourage voluntary compliance. Officials introduced the code to restrict the financial relationships between physicians and pharma companies, for example by prohibiting businesses from paying for overseas trips and providing free samples of products.

Other countries have successfully introduced voluntary marketing codes, but uptake in India has been slow. The slow process has prompted DoP officials to push back the deadline and could lead to tougher actions. "As of now it is voluntary for pharmaceuticals companies to follow UCPMP, but we are considering to make it compulsory in next few months," a senior government official told The Press Trust of India.

DoP Letter, PharmaBiz, The Press Trust of India

New Zealand Updates Labeling Guidelines in Response to MHRA Document

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has updated guidelines covering the labeling of drugs. Medsafe made the tweaks to the document in response to changes at the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA).

In the document, which was previously updated at the start of the year to remove obsolete sections on medical devices, Medsafe lists best practice guidelines from other regulators it thinks may be of use to companies. The link to the MHRA document was updated in the most-recent revision of the Medsafe guidelines. Medsafe is now up to version 1.5 of the document on the labeling of medicines and related products.

The Medsafe guideline document lists the legislation that regulates the labeling of medicines, details what content must be included and in what format and outlines the process for obtaining approval for new and revised labels. The bulk of the content is unchanged after the two revisions that Medsafe has made this year. 

Medsafe Guideline

Other News:

The High Court of Australia has ruled against Myriad Genetics in a case about the patents covering isolated BRCA1 nucleic acid molecules. “To attribute patentability to the invention as claimed would involve an extension of the concept of a manner of manufacture,” the court ruled. The setback follows a similar decision by the US Supreme Court in 2013. Ruling, Herbert Smith Freehills LLP

TGA has issued safety alerts about syrup forms of paracetamol and ibuprofen that are designed for children. The alerts, which cover products manufactured by Apotex but sold under multiple brand names, relate to the risk of plastic fragments being ingested after breaking off the lids of the bottles. Affected batches of the products are being recalled. TGA Notice, More

The Pharmaceuticals and Medical Devices Agency, Japan (PMDA) has started a bidding process for help with an upcoming survey and Internet-related tasks. PMDA is accepting submission documents for both tenders until 4 November, the day after which it will hold separate sessions relating to the two bid processes. A briefing on the process is being held this week. PMDA Notice, More (Japanese)

The Hindu has uncovered evidence that regulators’ interest in GVK Biosciences was triggered by emails from a disgruntled employee. GVK reportedly fired the employee over a love affair with a colleague, prompting the individual to send emails to regulators around the world detailing alleged clinical research quality failings at the contract research organization. The Hindu

The Central Drugs Standard Control Organization (CDSCO) is to meet with officials in Indian states to review the compliance of manufacturing units with World Health Organization (WHO) standards. CDSCO has called the meeting in response to the frequent issues raised by overseas regulators about the quality of Indian medical products and the plants in which they are manufactured. PharmaBiz

Bloomberg has profiled the cross-border trade in medicines between China and Hong Kong. Consumers, some of whom lack a prescription, travel from China to Hong Kong to buy drugs that are perceived to be of a higher quality. “Every time I’m here for one of my shopping trips someone or the other will ask me to bring them back some medicine,” a consumer said. Bloomberg

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Categories: Drugs, Medical Devices, Crisis management, Government affairs, Manufacturing, Regulatory strategy, Regulatory intelligence, News, Japan, China, Korea, Oceania, PMDA, CFDA, TGA, Medsafe

Tags: CFDA, medical device manufacturing, PMDA, TGA, Myriad Genetics

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