Asia Regulatory Roundup: China Looks to Revamp Drug Approval Process (3 November 2015)

Regulatory NewsRegulatory News | 03 November 2015 |  By 

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

China Proposes Drug Approval Reforms to Encourage Innovation

Senior Chinese officials are considering adopting legislation that would overhaul the drug evaluation and approval process in the country to encourage innovation by incentivizing research.

As it stands, only manufacturers can apply for drug approvals in China. Officials are now considering whether this disincentivizes drug research organizations, as they have to transfer their discoveries to manufacturers or set up in-house capacity to bring a product to market. The approaches entail either upfront costs or long-term loss of income, neither of which are attractive to drug researchers. The model being considered in China would allow firms without in-house capacity to file for approval.

Incentivizing research is one of two central tenets of the reform proposals. The other is focused on raising the standard of generic drugs, which regulatory officials accept are sometimes of a lower quality than those sold in the West. To bring China up to international standards, officials want to make sure the quality and efficacy of generic drugs are consistent with the characteristics of their reference products. The generic drug and research incentive reforms will be tested in a pilot project.      

Bi Jingquan, head of the China Food and Drug Administration (CFDA), outlined why the reforms are needed in a speech at the National People's Congress Standing Committee. Bi used the presentation as an opportunity to point out ways in which the rapid growth of the Chinese biopharma industry has exposed flaws in the regulatory process, as well as how these shortcomings are now affecting the development of innovative medicines and improvements to the quality of generic drugs.

CFDA Notice, China Daily, More (Chinese)

Japan Picks Six Drugs for Fast-Track Approval Program

The Japanese Ministry of Health, Labor and Welfare (MHLW) has selected six drugs for its fast-track approval program. Officials are aiming to process marketing applications for the products within six months, half the time it typically takes to review a drug in Japan.

Local companies feature prominently in the first batch of candidates accepted into the fast-track program. Astellas Pharma’s acute myeloid leukemia drug ASP2215, Phase I/II data on which was only posted in May, has made the cut, as have programs in development at fellow Japanese drugmakers Nobelpharma, Nippon Shinyaku Shionogi and Integrated Development Associates. Merck is the only company based outside Japan to win a place on the fast-track program.

The US-based firm secured a place on the list for its immuno-oncology drug Keytruda, which along with Astellas’ ASP2215 is one of two cancer drugs chosen by MHLW. Most of the other drugs on the list tackle rare genetic diseases, specifically Duchenne muscular dystrophy, hereditary angioedema and certain symptoms of tuberous sclerosis. The sixth drug is in development against influenza infections.

Each of the drugs will now receive certain benefits not offered to typical development programs. As well as halving the time taken to review each drug, Japanese regulators will provide faster clinical trial consultations. The six drug companies will be offered a consultation one month after they file their Phase III paperwork. Standard applications have to wait two months. MHLW has implemented the program as part of a broader initiative to revive the local healthcare sector.

MHLW Statement (Japanese), FiercePharmaAsia

India Caps Prices of Another 18 Products

The National Pharmaceutical Pricing Authority (NPPA) of India has capped the prices of another 18 products, including brands sold by Cipla and Merck. Medicines to treat diabetes, hypertension and pneumonia are affected by the extension of the price-capping policy.

NPPA has added more medicine packs to the list of price-capped drugs on multiple occasions since the original catalog was published in May 2014. The number of medicine packs on the list has now exceeded 700, The Economic Times reports, up from 652 when the policy first came into force. NPPA has expanded the price cap program in an attempt to give consumers access to a range of affordable treatment options, although some experts question whether the model achieves this goal.

Officials at NPPA are committed to the policy, though, and are interested in applying it more broadly. However, efforts to expand the program are being hindered by a lack of information. NPPA asked state governments and drug controllers, national-level officials, IMS Health, trade groups and others for pricing data on 98 formulations in July but is yet to receive the information. The price-capping body had set a 30-day deadline for the provision of the data.

Having failed to gather the data, NPPA is unable to fix the prices of the formulations. The products affected by the pricing problem include treatments for anemia, cardiovascular diseases, malaria and tuberculosis. It is unclear what, if anything, NPPA can do to resolve the situation. 

NPPA Notice, The Economic Times, Press Trust of India, More

Australia Explains How to Restrict Access to Clinical Trial Information

The Therapeutic Goods Administration (TGA) of Australia has released information to help users of its incoming online clinical trial submission system control who can view their documents. Users of TGA Business Services (TBS) are being advised to review whether their current access is appropriate.

TGA has published the guidance to help clinical trial sponsors avoid a situation in which the move to the online system makes their information visible to other departments within their organizations. If an organization wants to silo clinical trial information between departments, TGA recommends each unit registers as a sponsor with a unique client ID. The use of unique client IDs for different groups within the same organization will ensure clinical trial information is kept separate and private.

When siloing information in this way, a governance officer at the organization can be given access to clinical trial filings from each of the departments to ensure someone has oversight of the activities. A representative of a pharmaceutical company can have oversight at the same time as a governance officer, allowing the business that is supporting a trial to keep tabs on its progress without affecting internal processes at the sponsor. TGA shows how to set up these structures in its guide. 

TGA Statement

Other News:

A row over pricing in Pakistan has reportedly resulted in folic acid being unavailable for the past six months. Manufacturers are blaming the shortage on the Drug Regulatory Authority of Pakistan (DRAP), which has prohibited business from increasing medicine prices until June 2016. The cap on prices has reportedly disincentivized companies from producing the drug. The News

Australia’s TGA is expecting the shortage of ampicillin injections to be resolved in the coming months. TGA is now predicting that Alphapharm will resume supplying various forms of the product before the end of the year, while Juno Pharmaceuticals is expected to bring its capacity online in January. The supply shortage began in February. TGA Notice

The Central Drugs Standard Control Organization (CDSCO) of India has hired 31 assistant drug inspectors. CDSCO made the hires as part of the ongoing attempts to equip state and national-level regulators to effectively oversee the Indian pharmaceutical industry. CDSCO is also planning to set up a testing lab in Indore and offices in all other states. PharmaBiz, More

India is planning to push manufacturers of codeine-based cough syrups to do more to stop abuse of their products. Reuters


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