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Posted 07 April 2015 | By Nick Paul Taylor, Michael Mezher
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The government of India is considering taking action against the EU after the European Medicines Agency (EMA) recommended suspending some 700 drugs that relied on studies conducted by GVK Biosciences. EMA made its recommendation following allegations made by France’s National Agency for Medicines and Health Products Safety (ANSM) that GVK manipulated data in clinical trials it conducted over the past five years. ANSM and EMA alleged that GVK manipulated the results of electrocardiograms, and claim the manipulation was “systematic.”
Speaking to The Hindu Business Line, India’s Commerce Secretary Rajeev Kher said his government had met with EMA and French regulators to refute the allegations that studies conducted by GVK were manipulated. Kher told the paper that his country could move the issue to the World Trade Organization (WTO) if European regulators did not reverse course on the suspensions.
Kher also defended his country’s pharmaceuticals industry, saying that many of the regulatory actions taken against Indian companies were due to issues with processes, rather than with the finished product. – Michael Mezher
The Hindu Business Line
The shift from “one-size-fits-all” medicinal products to more targeted and customized drugs is introducing new challenges for the people involved in the development and commercialization of such products.
One of those challenges: Knowing how to bring your personalized medicine product to market. Want to learn how? Attend this upcoming RAPS workshop and hear from experts and EMA regulators involved in the regulation of personalized medicine. Register by 11 May 2015 to attend this essential event. [Read More...]
Pfizer is shutting down its 200-person vaccine sales operations in China after the government failed to renew the import license for its pneumococcal disease product. It is unclear why Chinese officials allowed the license to expire when it came up for renewal last year.
The expiration of the license for Prevenar — the pneumococcal vaccine sold in the United States as Prevnar — leaves Pfizer without a product for its 200-person sales operation to market. As such, the drugmaker is shutting down the unit immediately and expects most of its employees to be affected. In China, the inability to resolve the Prevenar licensing blockade leaves the population without access to a pneumococcal vaccine approved for use in infants.
Pfizer expects a shortage to arise, but as China never made Prevenar part of its childhood vaccination program the supply issue is unlikely to affect many people. The more significant, long-term concerns relate to what the disruption means for the relationship between Western pharma companies and Chinese regulators. Pfizer, for its part, is not completely turning its back on the Chinese vaccine market. The company is still trying to win approval for Prevenar 13, but is unsure how long the process will take. – Nick Paul Taylor
WSJ, Bloomberg, Reuters
The Central Drugs Standard Control Organization (CDSCO) has called on the Indian health ministry to fast track the release of money earmarked for use by the regulator. Government officials allocated around $250 million to the upgrading of regulatory agencies in the 12th Five-Year Plan, but are yet to start handing out the money. PharmaBiz reports that the funds will be used to increase staff, build new laboratories and boost the country’s pharmacovigilance efforts. CDSCO is also planning to put some of the funds toward a promotional campaign on the safe use of drugs.
Bureaucracy is reportedly behind the delay. PharmaBiz quotes anonymous industry insiders as saying the inability of government officials to quickly process the cash is causing confusion and further delays as regulators try to prepare to make investments without a clear idea of when they will have money to spend. The Drug Controller General of India (DCGI) Dr. GN Singh considers the delay serious enough to justify speaking out against the government.
“We have been pushing for this case with the government, persistently,” Singh said. The best-case scenario is that the government releases the money within the next six months. A lot is resting on the availability and effective use of the funds, which will support a wide-reaching overhaul of regulatory infrastructure and personnel at the state and national level. Hiring sprees and laboratory upgrades are among the planned projects awaiting the money. – Nick Paul Taylor
On Monday, South Korea appointed Kim Seung-hee to lead the country’s Ministry of Food and Drug Safety (MFDS). Kim has worked as a regulator in the country since 1988, and was the director of the National Institute of Toxicological Research before being appointed to Vice Minister of MFDS in 2011.
A spokesman for the office of the president said that Kim “has shown professionalism through her extensive work at the ministry.”
Kim will be replacing Chung Seung, who left the ministry in March for a parliamentary bid. Kim will be the second to lead the ministry after its restructuring from the Korea Food and Drug Administration (KFDA) in 2013. – Michael Mezher
Pakistan’s Consumer Protection Society (COPS) has lodged allegations against Abdul Qadir Javed Iqbal, the former director of QA< at the Drug Regulatory Authority of Pakistan. COPS alleges that Iqbal has a reputation for being corrupt and owns property that “he cannot reasonably justify holding” given his income as a government employee.
The allegations also claim that Iqbal is in violation of section 18 of the Act to provide for the establishment of Drug Regulatory Authority of Pakistan, which states:
The allegations state that Iqbal and his son, Haris Bin Javed, run several businesses that sell therapeutic goods, and demand that the government seize Iqbal’s property and recover salaries paid to him during his tenure at DRAP. – Michael Mezher
BioWorld Today has investigated why the backlog of applications awaiting processing at the China Food and Drug Administration (CFDA) jumped last year. The consensus is that two factors underpin the trend: understaffing at CFDA and deliberate delays to control healthcare costs.
More than one executive told the publication that delaying approvals of expensive new treatments is a way for the government to control healthcare spending, although nobody was willing to go on the record. “China is not the only country that is doing this. A lot of the European countries are doing it, too,” an anonymous industry source said.
That staffing shortages are thought to be playing a role in the growth of the backlog is much less controversial than the accusation of deliberate delays. “Their workload is ... huge. On top of that, they have other assignments like drafting the biosimilar guideline. The reviewers have been working overtime a lot,” Fiona Cheng, director of preclinical, clinical and registration at Genor Biopharma, said. – Nick Paul Taylor
Medscape reports that some cancer experts are voicing concerns over Japan’s “patient-requested” treatment system, which will allow patients access to investigational products following a six-week review. The experts, who authored a comment which appeared in The Lancet last month, claim the plan is a step in the wrong direction.
According to Medscape, the new system set to take effect in 2016 would let patients get access to cancer treatments approved outside Japan before they have been approved by the Pharmaceuticals and Medical Devices Agency (PMDA). Patients would have to cover the costs of the treatments themselves, as the drugs would not be covered under the country’s universal healthcare system.
Critics say the measure will not have a major impact for patients, as many of the drugs that would become accessible under the plan cost thousands of dollars per month, making them out of reach for most Japanese patients. They also argue that the plan doesn’t address the root of the issue, which they claim is the lengthy process for launching clinical trials in Japan. – Michael Mezher
Medscape, The Lancet
The number of complaints and tip offs sent to CFDA doubled last year as more and more consumers informed the regulator about counterfeit products and false advertising, China’s state news agency Xinhua reports.
Reports of fake products and misleading adverts sat alongside complaints about adverse events and unlicensed manufacturing on the list of topics most frequently communicated to CFDA. Around three quarters of the 562,402 complaints sent to CFDA last year related to food. Pharmaceuticals and dietary supplements accounted for around 13% and 6% of reports, respectively.
Most complaints were collected by the government’s whistleblower hotline, which officials say is having a significant impact on how they monitor the food and drug industries. More than half of all major investigations that CFDA and collaborating law enforcement agencies began last year were triggered by a complaint or tip off. – Nick Paul Taylor
The introduction of Chinese healthcare pricing reforms has sparked protests in Chongqing. Around 1,000 dialysis patients led public opposition to the new policies after hospitals increased the cost of services to offset lost earnings from drug sales. Chongqing has reverted back to the old pricing system for now to quell the unrest. China Medical News
India is planning to add AIDS and tuberculosis drugs to its list of essential medicines. The move would cap the prices of drugs for the 2.2 million people who live with tuberculosis in the country. All drugs made available for free as part of existing disease control programs are expected to be added to the list. Reuters
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has started accepting applications from companies that want to use its early access pathway. The new pathway came into force on April 1 and aims to cut the time it takes to bring important medicines to Japanese patients. PMDA’s interest in such a policy echoes the move toward accelerated assessment in the US and Europe. BioCentury
DCGI is reportedly planning to link periodic safety update reports (PSURs) to the Pharmacovigilance Programme of India (PvPI). Currently, companies must submit PSURs to CDSCO for four years, after which safety monitoring comes under the remit of PvPI. DCGI wants to integrate the two systems to centralize the collection and analysis of post-marketing drug safety data. PharmaBiz
India has dropped the free drugs program it started in 2012. As recently as last year, officials were aiming to provide the 348 products on the essential medicines list for free, but that ambition was subsequently scaled back to 50 drugs. Now, the initiative has been scrapped altogether. Individual states can still implement free drug programs. The Times of India
Natco Pharma is supporting a two-month training program for potential drug inspectors in India. The Hitech Institute of Advanced Pharmaceutical Sciences is running the program in conjunction with the drugmaker to equip pharmacy graduates with the skills they need to secure a position as a regulatory inspector. The Hindu
India is aiming to help local drugmakers access China and Japan by addressing non-trade barriers. The government thinks sales in both countries are limited by regulatory hurdles, such as difficulties with the registration process in Japan. Officials plan to run trade promotion initiatives targeting Japan and are pressuring China to make it easier for Indian companies to access the market. Press Trust of India
CFDA has cleared the Cytori Celution System for sale in China. The system — which is sold in China by Lorem Vascular under license from Cytori Therapeutics — is a device for extracting, washing and concentrating a patient’s adipose-derived stem and regenerative cells. Press Release
Tags: Asia Regulatory Roundup, Regulatory Roundup
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