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Regulatory News | 03 March 2015 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The Japanese health ministry will temporarily ban Novartis from manufacturing or selling prescription products over the alleged manipulation of clinical trial data and concealment of side effects. Authorities will start the 15-day suspension on 5 March 2015.
Novartis was warned about the ban by the Ministry of Health, Labor and Welfare (MHLW) last month, at which time it downplayed the financial effect of the sanctions. The action is nonetheless a strong indictment of Novartis’ operation in Japan. Authorities have never previously handed out such a punishment over the reporting of side effects.
The Swiss drugmaker angered authorities over the handling of data on its blood cancer drug Diovan and leukemia treatments Gleevec and Tasigna. An internal probe revealed 3,200 side effect cases linked to 26 types of drugs went unreported.
The Drugs Controller General of India (DCGI) has barred another company for data fabrication. DCGI told Arion Healthcare of its ban on 16 February, just three days after it sent an almost identical letter to Kivi Labs.
Both cases involve alleged malpractice by consultants. The quality assurance manager at Arion, a man named Manoj, is accused of working with a private consultant to fabricate documents that were then submitted to regulatory authorities in support of an application for the fixed-dose combination (FDC) of cefixime and ofloxacin.
The consultants and drugs involved were different in the cases of Arion and Kivi, but the practices that prompted the punishments are similar. At both companies, consultants allegedly fabricated FDC files with the knowledge of people within the company. PharmaBiz reports DCGI is now preparing to take action against the consultants.
Arion Letter I Kivi Letter I PharmaBiz
China has begun a campaign to standardize and centralize drug procurement and distribution. The push is an attempt to stop corruption, cut prices and improve access to drugs in rural areas, Reuters reports.
The government wants to see an immediate change in how pharma companies sell drugs. Currently, many drugs are sold to distributors, the network of which adds to the complexity — and, in Beijing's opinion, the inefficiency — of the supply chain. Officials want manufacturers to abandon this practice and begin selling directly to hospitals.
Early reports suggest the campaign is more about encouraging alternative practices than adopting new regulations. China is pushing for authorities to step up the centralization and standardization agenda, while also improving the distribution channels that deliver drugs to rural areas.
The Indian Drugs Technical Advisory Board (DTAB) has dismissed a proposal to extend the mandatory post-market surveillance period to six years. A committee created to think up reforms of the clinical trial and drug approval process in India was behind the planned extension.
DTAB saw no merit in extending the surveillance period from four years to six years, but it was more impressed by some of the panel’s other suggestions. The board lent its support to plans to offer care to patients who fall ill during a clinical trial, make drugs available once a study has finished and tweak the approach to injury compensation.
Perhaps most significantly, DTAB agreed that in some circumstances drugs approved in well-regulated markets such as the United States and the European Union could be sold in India without running local trials. The Ministry of Health has previously said such a waiver should only apply to orphan drugs and in times of national emergency.
DTAB Meeting Notes I RegLink News
The Drug Regulatory Authority of Pakistan (DRAP) has raided a plant accused of unlawfully producing copies of Gilead Sciences’ blockbuster hepatitis C drug Sovaldi. Officials plan to file police reports against the facility's senior managers and production heads.
DRAP conducted the raid just days after government officials told it to make the eradication of fake and substandard drugs a priority. The shutdown of the Sovaldi plant is part of a broader clampdown by the regulator. “Several factories have been sealed and action as per law is being taken without discrimination,” Pakistani Health Minister Saira Afzal Tarar told The News.
The decision by the facility to produce a copy of Sovaldi is unsurprising given the large number of patients with hepatitis C in Pakistan and the delays in bringing an official product to market. While other countries fast tracked Sovaldi, the application in Pakistan was held up, first by DRAP and then by the Federal Ministry of Health Services Regulations.
The News I The Nation
After months of steadily escalating speculation, the Indian government has released its 2015 budget. The details, perhaps predictably, failed to live up to the hype, with representatives of the pharma and medical device industries expressing disappointment at the lack of policies to boost manufacturing.
Ramesh Swaminathan, Lupin Pharmaceuticals’ chief financial officer, led the sighs of disappointment from the drug production industry. While Swaminathan felt the budget was progressive and balanced, he lamented the failure to propose policies that would incentivize local R&D and manufacturing. “The budget fell short of any kind of roadmap for the pharma sector,” Swaminathan wrote in The Economic Times.
The medical device industry was equally unenthused. GSK Velu, managing director of Trivitron Healthcare, told the Press Trust of India the budget “has done nothing for the heavily import dependent medical devices industry.” Velu expected the government to propose a tax holiday for medical device firms that set up production plants and a streamlining of the associated paperwork.
The Economic Times I Press Trust of India
India’s National Pharmaceutical Pricing Association (NPPA) is continuing to push for the addition of marks to the packaging of medicines to denote they are under price control. A Bangalore-based pharmacy trade group wants the markings to be an eye-catching shade of red. PharmaBiz
Stent manufacturers have told PharmaBiz they want NPPA to adopt a pricing regime based on the performance and features of each product. The price of stents has become a hot topic, with NPPA calling leading manufacturers for a meeting last week to discuss how to proceed. PharmaBiz
China Food and Drug Administration (CFDA) has added a food safety standards section to its online presence. The aim is to make it easier for people to find information about food safety standards. CFDA is also continuing with its food sampling program. CFDA Notice (Chinese) I More
The Pharmaceutical Export Promotion Council of India (Pharmexcil) has called for regulators in Vietnam to recognize Indian Pharmacopoeia standards for exports. Vietnam currently accepts the US and British Pharmacopoeias. PharmaBiz
Maharashtra FDA is reportedly processing manufacturing licenses much faster since it adopted an online system last year. Since the system came online in April 2014, the state regulator has handled 14,000 applications in a timely manner. PharmaBiz
The number of whistleblower reports received by GlaxoSmithKline jumped more than 1000% in 2014, a trend it admits was largely driven by the corruption scandal in China. FiercePharmaAsia
Authorities in Korea have approved Masimo’s noninvasive Pleth Variability Index (PVI) after ruling it is an effective way to predict fluid responses of patients on mechanical ventilators. Press Release
Tags: Asia Regulatory Roundup, Regulatory Roundup