Asia Regulatory Roundup: Shanghai to Host New Drug Evaluation Center to Speed CFDA Approvals (21 July 2015)

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

Shanghai to Host Drug Evaluation Center as CFDA Plots Path to Speedier Approvals

China Food and Drug Administration (CFDA) is planning to help set up a drug evaluation center in Shanghai to cut the time it takes to evaluate and approve new medicines, CCTV reports. The new site will go part of the way to bringing regulatory staffing levels closer to CFDA’s international peers, which currently have significantly larger headcounts.

As it stands, CFDA has 120 people working on medicine evaluations, an order of magnitude less than the US Food and Drug Administration. If everything goes to plan, the regional medicine center in Shanghai will share the burden of evaluating new medicines with the 120 CFDA staffers, theoretically enabling the regulator to shorten its notoriously long approval times. At least one company claims to have been waiting 10 years to have its oncology drug application processed.

“It only takes a few weeks to months to evaluate a new medicine. Most of [the time] is only spent on queuing for evaluation and approvals. The evaluation center is also busily evaluating other drugs,” Chen Wei, president of Shanghai Zhangjiang Economic Research Institute, said. Shanghai wants to improve the situation while making itself more attractive to biopharma companies. The goal is to encourage companies to set up research centers in the city.

CCTV, FiercePharmaAsia

Supreme Court Blasts India’s ‘Absurd, Irrational’ Drug Pricing Model

The Indian Supreme Court has ordered the government to review its drug pricing model within six months. A change in legislation in 2013 saw India switch to a market-based pricing system, but the future of the model has been thrown into doubt by the strong criticism of the Supreme Court.

Three justices of the Supreme Court considered the merits of the market-based pricing model after a non-governmental organization criticized perceived failings with the approach. The case against the current pricing model is based upon concerns that it inflates the cost of medicines, while the law that ushered in the approach has also been criticized for excluding life-saving drugs and treatments required for national health programs against malaria, tuberculosis, HIV and other diseases.

The Supreme Court was convinced by the arguments, The Economic Times reports. “The Center’s drug pricing policy seems to be unreasonable and irrational for fixing prices at the very high level. You are fixing the maximum price of a medicine above the retail price of the leading company of the same drug. It is absurd,” the three justices concluded. The government now has six months to reconsider how it sets the prices of medicines.

The Economic Times, India Today

Surprise CFDA Inspections Land 6 Wholesalers in Trouble as Regulator Steps up Oversight

CFDA has called on its local units to step up oversight of drug wholesalers. The new policy follows a clutch of surprise inspections by CFDA, in which it identified illegal activities including temperature data fabrication and the creation of fictitious storage sites.

CFDA snagged six wholesalers in the spate of surprise inspections and is publicly pushing its local units to keep up the pressure on the sector. The breadth of failings identified at the six wholesalers suggests the industry is plagued by many serious problems. One company made up fictitious storage sites and quality management personnel, while another was found to have tampered with the data from temperature and humidity loggers. A third lacked a temperature monitoring system altogether.

The litany of failings raises significant doubts about the ability of the wholesalers to keep medicines in appropriate conditions. All six businesses lost their pharmaceutical quality management standard certificates and CFDA has ordered four of the wholesalers to suspend operations while authorities conduct an investigation. CFDA took tougher actions against two wholesalers that were caught selling solutions containing codeine illegally.

Xinhua, CFDA Notice (Chinese), More (Chinese)

IMS: Price Controls are Failing to Increase Access to Medicines in India

IMS Health has questioned the wisdom of capping the costs of medicines, citing evidence that use of drugs subject to price controls has fallen by 7% in rural India over the past two years to support its argument. The data suggest price controls are failing to make it easier for the rural poor to access medicines.

Information services company IMS released the figures in a report on the impact of price controls on the availability of medicines in India. The pricing policy is intended to make it easier for people on low incomes to access medicines, but IMS thinks it is doing more to help the wealthy. As well as noting a decline in the consumption of price-controlled medicines in rural India, IMS also found an uptick in use of drugs not covered by the scheme over the same period, Press Trust of India reports.

The report is backed up by earlier studies. “These conclusions are corroborated by similar outcomes in China, the Philippines and South Korea, where price controls have consistently failed to improve overall access to medicines,” the report concluded. IMS recommends the government invest in healthcare infrastructure and make universal health coverage available to more people if it wants to improve access to medicines in India.

Press Trust of India, PharmaBiz

China Finalizes Reclassification of Medical Devices as Reports of Adverse Events Jump

CFDA has reported an 18.6% year-on-year jump in reports of adverse events related to medical devices, Xinhua reports. The news coincided with the finalization of documents on the classification of medical devices in China, which will see such products grouped into four main categories.

In 2014, China received reports of 41,018 adverse events linked to medical devices, a notable increase over the previous year. The batch of side effects includes 98 deaths. Medical polymer materials, injection and puncture tools and sanitary materials topped the list of the classes of devices that were associated with the most adverse events.

News of the rise in adverse events emerged at the same time as CFDA finalized a document to adjust how medical devices are grouped. CFDA will now split the product class between passive, active, invasive and reusable surgical devices. Combination devices are to be segregated off in their own special category.

CFDA also released three appendices to its good manufacturing practices for sterile medical devices, implantable products and in-vitro diagnostics. The documents will come into force on Oct. 1.

Xinhua, CFDA Notice (Chinese), GMP Appendices (Chinese)

Other News:

The National Pharmaceutical Pricing Authority (NPPA) of India has brought another 39 drugs under cost control. The price of drugs to treat diabetes, infections and other disorders will fall by as much as 40% following the implementation of the controls. GlaxoSmithKline and Abbott Laboratories are among the companies affected by the revised policy. Press Trust of India, The Economic Times

Maharashtra has maintained its campaign against online retailers of prescription medicines. Officials in the state have followed up their actions against Snapdeal by launching an investigation into another online retailer, Shopclues.com. The site is accused of selling sexual stimulants without a prescription. Online sales of abortion pills are reportedly “rampant,” too. The Times of India

Australia’s Therapeutics Goods Administration (TGA) has posted an update to its terminology for medicines. The post clarifies that while aspects of its 1999 guidance on the approved terminology of medicines are out of date, the rules it established are still active. TGA Notice