Asia Regulatory Roundup: China's New Device Regulations (19 January 2014)

Posted 20 January 2015 By Nick Paul Taylor

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

CFDA Strengthens Medical Device Production Regulations

CFDA has confirmed its revised regulations on good manufacturing practices (GMP) for medical devices will come into force on 1 March. The revised document — which was adopted late last year — covers GMP requirements relating to facilities, equipment, documents and quality control.

The changes could force medical device manufacturers to take on more staff, Xinhua reports. Plants must have staff monitoring the quality of the manufacturing operation, as well as an employee who cooperates with institutions tasked with investigating malpractice. If quality problems are detected, manufacturers should halt sales immediately. 

Updated guidance on good distribution practices for medical devices came into force in December. The distribution regulation mandates the creation of quality management systems at distributors. CFDA will also assess quality control measures covering the purchase, acceptance, storage, sales, transportation and after-sales service of medical devices.

CFDA Notice I Xinhua I More

CFDA Approves Novel Polio Vaccine

The China Food and Drug Administration (CFDA) has approved an inactivated Sabin polio vaccine. Observers hailed the approval as evidence of both China’s increasingly sophisticated development capabilities and the willingness of CFDA to approve innovative products.

A team at the Chinese Academy of Medical Sciences developed the vaccine, which is the first of its kind to be produced in the country, Reuters reports. CFDA expects demand for the vaccine to rise to tens of millions of doses a year as the healthcare system uses the Sabin IPV vaccine in favor of the older, orally administered product. The oral vaccine can cause polio.

The World Health Organization (WHO) praised the approval, while CFDA hailed it as a step in China’s growth as a developer and user of innovative therapies. “As an important innovative product which our country has the full intellectual property rights to, the approval of this vaccine is a successful leap forward to take China's vaccines from ’made in China’ to ’created in China,’” CFDA said.

Reuters I FiercePharma I CFDA Notice

Pakistani Politician Criticizes DRAP CEO Nominations

The long, troubled search for a CEO of the Drug Regulatory Authority of Pakistan (DRAP) continues to encounter new problems. DRAP’s policy board passed two names to the prime minister earlier this month for a final decision, but the lack of a candidate from within the health department has prompted criticism.

Senate Committee on Commerce Chairman Haji Ghulam Ali said it is unacceptable that both the final candidates work at large pharmaceutical companies, The Express Tribune reports. Ali and others are concerned about whether a DRAP led by either of the nominees would serve the interests of the Pakistani people and the local pharma industry.

Few, if any, people are happy with the current situation. The ongoing drug pricing row is yet to result in a concrete policy, but the government is seemingly set on prohibiting any increases until 2016, Business Recorder reports. Neither DRAP nor the government appears willing to incorporate industry recommendations into their policy. Some firms have reportedly increased prices without permission. 

The Express Tribune I Business Recorder I More

Health Official Tells CDSCO Staffers to Work Overtime as Budget Cuts Loom

A senior official at the Indian Ministry of Health has told employees of the Central Drugs Standard Control Organization (CDSCO) to work overtime to boost output at the regulator. The official made the request days before news broke of deep budget cuts at the ministry of health.

On 10 January, India’s Joint Secretary of the Ministry of Health & Family Welfare visited CDSCO staffers at one the regulator’s offices in Mumbai. The visit covered a wide range of topics, from the need to improve hygiene in the canteen to the importance of staff working extra hours. Overtime is deemed necessary to increase the output of the laboratory and zonal office.

Days after the visit, the Press Trust of India reported the health ministry faces a 20% reduction in its budget. The drop is the result of underutilization of the current budget, leading officials to downplay the likely impact of the cuts. However, with aspects of the health machinery bemoaning a lack of resources — and the alternative medicine unit seeking more money — others are concerned.  

CDSCO Report I The Press Trust of India I More

Korean MFDS to Help Local Vaccine Firms Obtain WHO Prequalification

The Korean Ministry of Food and Drug Safety (MFDS) has outlined plans to help local vaccine manufacturers receive prequalification from WHO. MFDS will provide companies with counselling and consulting services to prepare them for the WHO assessment, which opens global markets to vaccine manufacturers.

Korea’s vaccine exports currently total $200 million, Korea BizWire reports, 95% of which are part of the WHO prequalification program. With vaccine exports so closely tied to prequalification, MFDS is to start providing manufacturers with information about the documents they must submit to WHO. MFDS will also offer mock inspections of plants to help companies prepare for when WHO visits.

To date, WHO has approved 14 Korean-made products under its prequalification program, the first of which received certification in 1996. 

Korea BizWire

Other News:

The Association of Indian Medical Device Industry (AIMED) has stepped up its campaign against proposed changes to the sector. AIMED wants the government to change import duties before it loosens laws on foreign investments in the medical device sector. The trade group is also fighting for changes to the Drugs and Cosmetics (Amendments) Bill 2015. The Economic Times I PharmaBiz

Gilead has vowed to appeal the Indian Patent Office’s rejection of intellectual property covering its blockbuster hepatitis C drug, Sovaldi. The rejection of the patent application could clear generics manufacturers to begin producing the drug without Gilead’s permission. The Press Trust of India

The Indian Health Ministry is still considering whether to go ahead with plans to ban the use of polyethylene terephthalate (PET) in certain forms of pharmaceutical packaging. Since the proposal was introduced in September, multiple industry groups have complained. PharmaBiz

CDSCO expects to start its survey of substandard and spurious drugs within the next three months. The survey — the first of its kind run by the Indian government since 2009 — is intended to provide data to counter third-party claims and help officials focus resources on high-risk areas. PharmaBiz

The Delhi high court has ordered Glenmark to stop manufacturing linezolid, an antibiotic. Symed Laboratories brought the case against Glenmark, which it alleged is infringing against its patents covering the production of linezolid. LiveMint

Australia's Therapeutic Goods Administration (TGA) has published a summary of electronic common technical document (eCTD) workshops it hosted late last year. The summary covers the question and answer sessions. TGA Summary

The Gujarat Food and Drug Control Authority (FDCA) is to receive training from the company that developed the US Food and Drug Administration's online education program. Officials in Gujarat hope the training will lead to quality improvements at local manufacturers. The Press Trust of India

Indian physicians have complained the country’s clinical trial regulations are preventing them from joining research programs that could benefit patients. The legislation reportedly stopped India from joining a trial to test whether aspirin can prevent tumors from reoccurring. The Financial Express

The Delhi Pharmaceutical Trust (DPT) has urged the government to drop plans to change the criteria that guide senior regulatory appointments. The argument centers on the suitability of people with medical degrees to hold senior positions at CDSCO. PharmaBiz

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