Asia Regulatory Roundup: Drug Safety, Traceability at Forefront of China’s Health Reform Plan (16 February 2016)

Posted 16 February 2016 | By Nick Paul Taylor 

Asia Regulatory Roundup: Drug Safety, Traceability at Forefront of China’s Health Reform Plan (16 February 2016)

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

China Puts Drug Safety and Traceability at Forefront of Healthcare Reform Program

China has committed to bolstering the safety controls and traceability requirements that cover its local drug market. The commitment, which was made at a meeting of the State Council, is part of a raft of healthcare reform initiatives that are collectively intended to lessen China’s reliance on imports by strengthening its domestic pharmaceutical industry.

Government officials view improvements to the quality of locally-made medical devices and drugs, particularly those that are perceived to be essential, as key components of a strategy designed to result in domestic manufacturers capturing a larger share of the Chinese healthcare market. Tipping the balance between domestic and overseas manufacturers could help China rein in its spending on healthcare while delivering a boost to the local economy, a cocktail of benefits the government finds compelling enough to warrant putting the topic at the forefront of its reform agenda.

“Accelerating the development of our domestic drug industry will better serve our people’s healthcare needs, help build a healthier China and unleash economic growth potential,” officials wrote in a statement translated by Reuters. As well as pushing to make Chinese quality a match for any other country, the government is considering implementing compulsory commercial insurance that covers product safety. Consideration of the insurance plan is proceeding in parallel to attempts to speed the clinical trial and approval process for important products.

Domestic developers of innovative medicines and branded generics will get extra support, too. China wants to see such companies grow larger, a process it intends to facilitate by supporting mergers and acquisitions. “[We want to] foster industry leaders in order to solve the 'scattered' nature of the market,” officials wrote. Officials intend to expand the market and improve business conditions for these new industry leaders, notably by extending modern drug distribution networks into rural areas and improving taxation, prices and government procurement policies.

Any local drug or medical device company could benefit from these policies, but the government is particularly keen to support manufacturers of traditional Chinese medicines (TCM). The TCM plan is a major component of the reform strategy, with officials planning to set up health services focused on the delivery of such products. With such services stimulating local demand for TCM — and an export-focused strategy potentially expanding the market further still — officials are aiming to improve standards and encourage the use of modern technology to aid development of the sector.

Government Statement (Chinese), Reuters

New Zealand Pushes Ahead with Data Sheet Standardization After Collapse of TGA Collaboration

New Zealand has proposed adopting a standardized data sheet template based on the European Summary of Product Characteristics (SPC). The suggestion comes nearly three years after Australian officials initiated a consultation that was expected to lead to new standards in New Zealand, only for the plan to fall apart when the trans-Tasman regulatory authority was scrapped in 2014.

Organizations including the trade group Medicines New Zealand contributed to the consultation in the belief that its findings would be adopted by the Australia New Zealand Therapeutics Products Agency (ANZTPA). With ANZTPA being abandoned, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) was left with feedback on the need for standardized data sheets but no internal regulatory agenda for the implementation of such a template. That changed this week when Medsafe outlined a plan to adopt a template based on the European SPC from the start of next year.

Medsafe considered the SPC and United States Food and Drug Administration’s Product Information format as possible templates for its own standard data sheet before deciding a slightly modified version of the European document is its best option. The changes to the SPC bring the data sheet template in line with legislative requirements in New Zealand. In moving toward the European SPC, Medsafe has responded to feedback gathered ahead of the planned ANZTPA proposal that favored the adoption of an international standard.

Respondents to that previous consultation listed the use of an international standard alongside the reordering of data sheets as one of their top priorities. As it stands, the format in New Zealand varies from data sheet to data sheet, making it hard for healthcare professionals to know where to look for the most important information. Worse still, “The most sought after information is often not near the beginning,” Medsafe wrote. The new template rectifies this issue by making manufacturers put critical details such as the name and strength of the product at the top of the data sheet.    

Medsafe has released a template to help manufacturers adapt to the new format, a process officials think will amount to a shuffling of existing text. The regulator sees no need for changes to the content itself. Organizations have until the end of March to submit feedback, after which Medsafe will push ahead with plans to bring the new template into force on 1 January 2017.

Medsafe Consultation

Japan’s PMDA Proposes Offering Video Conferencing as an Alternative to Face-to-Face Meetings

The Pharmaceutical and Medical Devices Agency (PMDA) of Japan is planning to give companies the option to hold regulatory consultations via video conferencing. Officials see the technology as a way to free applicants from the need to travel to receive face-to-face advice from the regulator.

PMDA initiated a consultation on the proposal this week. If the plan goes ahead, PMDA will use video conferencing to connect the industry to officials at its Kansai branch in Osaka. Officials at the Osaka office, which is involved with consulting on research and development strategies, already use the technology to liaise with their colleagues at the PMDA site in Tokyo.

The consultation will assess industry interest in the technology and willingness to pay the proposed fee. “If you want to use the video conferencing system at the time of performing a face-to-face advice consultation in Kansai Branch, you will need a use fee of 280,000 yen ($2,460) across the board,” the regulator wrote in a document listing the fees for its consultation services.

PMDA has given the industry until 12 March to provide feedback in the proposal.

PMDA Statement (Japanese)

CFDA Reports Fall in Number of Illegal Food and Drug Cases in 2015

China Food and Drug Administration (CFDA) has posted a year-on-year drop in the number of illegal food and drug cases. In 2015, 353,951 cases relating to violations of food and drug laws were filed in China, a reported decline of around 12% compared to the prior year.

Officials at CFDA have attributed the downward trend to a ratcheting up of their coordination with other departments, Xinhua reports. Illegal activities related to food accounted for the majority of the cases filed last year. Violations of drug laws, the second most common type of case, accounted for 25% of all the reported illegal activity. Medical devices represented just 3% of the case load.

China acted on the reports of illegal activity by shutting down the operations of more than 13,000 organizations. The state also revoked the licenses of more than 32,000 violators. CFDA plans to build on these activities in 2016 by continuing to improve coordination with other departments, notably by implementing information technology that can speed the transmission of intelligence.

Xinhua, CFDA Notice (Chinese)

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