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Regulatory News | 02 June 2015 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The Drugs Controller General of India (DCGI) has committed to hiring 200 inspectors and acquiring 20 mobile testing laboratories in the coming months to extend its reach into remote areas, PharmaBiz reports. DCGI already has one mobile testing lab operating in Gujarat and is talking to the US Pharmacopeia (USP) and German regulators about obtaining more.
Ambitious plans to bolster regulatory infrastructure in India have failed to come to fruition in the past, but DCGI Dr. GN Singh sees nothing getting in the way of the latest initiative. “Money is not a criterion for us. We are spending close to [$1.25 million] for each mobile drug testing van. These vans will...enable onboard drug inspectors to collect drug samples from the remote and faraway places in the country and instantaneously test them for their quality,” Singh told PharmaBiz.
Uttar Pradesh, Bihar, Jammu, Kashmir and Telangana are first in line to receive the mobile testing labs. The labs are part of an attempt by DCGI to eliminate blind spots in its oversight of production plants in India and speed up the rate at which it tests samples. Officials have developed software and are working on an international alert system to further the same objectives.
China Food and Drug Administration (CFDA) is moving to spare small and medium-sized enterprises (SMEs) developing innovative drugs or medical devices from paying its new registration fees. The decision frees companies that meet the criteria from the burden of the newly inflated charges.
Officials in the Chinese government took the stance to advance their efforts to support the growth of SMEs. While companies wanting to register a locally made drug will now need to pay ¥624,000 CNY ($100,000) in registration fees — 1600% more than in the past — the process is free for SMEs that are applying for approval of an innovative therapeutic or medical device for the first time. Larger firms will bear the cost of financing improvements to CFDA’s regulatory infrastructure.
Such improvements are needed if China is to stop long and inconsistent timelines for the approval of new products, clinical trials and other components of a thriving healthcare system from holding back the growth of the industry. Prior to the introduction of the new rates, which are low relative to the West, China was still using fees set in 1995. Since then, the work involved in overseeing the country’s drug and medical device sectors has increased significantly.
Xinhua(Chinese), Ministry of Finance (Chinese), Regulatory Focus
An advisory committee to the Indian government is due to meet this month to discuss online drug sales. The meeting is a precursor to the creation of a regulatory framework for the legal sale of prescription drugs online in India.
The topic was thrust to the top of the national agenda last month when Maharashtra Food and Drug Administration (FDA) began an investigation into the sale of drugs on Snapdeal, an Indian e-commerce platform. A regulatory official told The Times of India the government has responded by having the Drugs Consultative Committee discuss the topic. Representatives of the national and state governments sit on the committee.
Officials at the office of the DCGI are also assessing the topic, notably by asking state regulators for suggestions on how to monitor online sales and evaluating the methods adopted by foreign authorities. At this stage, it is unclear how long the process will take, but with sales likely to continue on corners of the internet until coordinated action is taken, officials are keen to establish guidelines.
The Times of India
China has started an investigation into a top medical device regulatory official. News of the probe into the head of CFDA’s medical devices supervision emerged days after a Chinese prosecutor said bribery allegations against another leading healthcare official are being investigated.
CFDA outlined the investigation into alleged “serious disciplinary violations” by the medical device chief, Tong Min, in a press release, but gave few specific details of the case. China typically uses the term “serious disciplinary violations” to describe corruption, Reuters reports, and has been on a campaign to root out bribery and other similar crimes in recent months. The campaign has led to investigations into very senior officials.
Tong has overseen medical device manufacturing and distribution at CFDA since 2013 and worked at the regulator for more than a decade. The investigation into Tong is advancing in parallel to a probe into the activities of Wang Yu, a former leading official at Bureau of Medical Administration. Wang’s position gave him responsibility for managing clinical trials and other areas of healthcare. The allegations against the former healthcare official involve bribery.
Maharashtra FDA is accelerating its attempts to get compensation for people affected by metal-on-metal hip replacements from Johnson & Johnson. The Indian state regulator has spent the past few years pursuing the case after becoming frustrated with progress.
Regulatory and industry officials have made a string of claims and counterclaims in the courts over the past few years, leading to a point at which they have sat down together to talk through how to resolve the case, PharmaBiz reports. Almost 1,000 patients reportedly registered with a helpline for the implants, 184 of whom required revision surgery. In 2012, J&J had $3 billion set aside to cover the costs of any successful compensation claims.
The case is one of several medical device-focused campaigns being run by Maharashtra FDA. The state regulator, which has led the push for price controls on medical devices, started a new drive this week when it took action against 23 sellers and importers of e-cigarettes. Maharashtra FDA views the retailers’ activities as violations of the Drugs and Cosmetics Act, namely the stipulation that products containing more than 2mg of nicotine can only be sold on prescription.
PharmaBiz, The Times of India
Law firm Ropes & Gray has published a summary of CFDA’s recently released technical guideline on the clinical evaluation of medical devices. The guideline outlines when CFDA will grant a clinical trial waiver to a medical device developer and when data generated in studies run outside China can be included in submissions to the regulator. Ropes & Gray
Singapore’s Health Sciences Authority (HSA) has seized 94,000 units of illegal health products following a police raid on an apartment. Officials are now questioning a 22-year-old Chinese national in relation to the case. The seizure, the value of which HSA estimates at $150,000, contained 80 different types of products. Press Release
DCGI has set a six- to eight-month timeline for the completion of a large-scale drug quality survey. The Indian regulator expects to test 42,000 drugs, an initiative DCGI GN Singh said will “help negate misnomers as various numbers are being circulated about percentage of spurious/low quality Indian drugs.” The Hindu
The US Pharmacopeia is developing monographs for a Herbal Medicines Compendium for South and East Asia. Work is focused on 28 monographs, the creation of which is intended to harmonize quality standards across the region. PharmaBiz
Tags: Asia Regulatory Roundup, Regulatory Roundup