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Regulatory News | 21 April 2015 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The Indian health ministry is planning to rewrite legislation covering the integrity of data submitted in regulatory applications. Officials want to add a section to Schedule Y of the Drugs and Cosmetics Rules to clarify the consequences of filing fraudulent results.
As it stands, the law states data must be authentic and self-certified but gives no details of what happens to companies that fail to meet this standard. With data integrity failings blighting Indian companies’ local and international activities, the government has decided it is time to create a legal basis for the punishment of offenders, PharmaBiz reports.
The proposed text reads: “The Licensing Authority reserves the right to reject any data or application or debar the applicant for a specific period to make any application to the office of Drugs Controller General [of India (DCGI)] as the case may be if such data or contents of such documents are found to be of doubtful integrity.” The text was proposed at a Drugs Technical Advisory Board (DTAB) meeting.
While the text is new, the punishment it gives legal force to is already being used. In February, DCGI banned Arion Healthcare and Kivi Labs from applying to the offices of the Central Drugs Standard Control Organization (CDSCO) for any purpose for five years. Both cases involved the firms allegedly working with consultants to fabricate documents in applications covering fixed-dose combinations.
The US Food and Drug Administration (FDA) is still struggling to get inspectors into China. FDA started working to increase the headcount of its Beijing office to 26 two years ago, but is yet to get anywhere near that figure because of ongoing difficulties with securing long-term working visas.
Pharmalot reports the office currently has 10 full-time employees, of whom three are dedicated to drugs. The figure fluctuates as tours of duty start and end — six of the employees only recently got their visas — but there is no sign of a sustained rise toward the target headcount. Faced with these difficulties, FDA appears to be rethinking its approach.
“Rather than focus on a specific number of inspectors, FDA uses its resources in a risk-based manner,” a representative said. The statement is less optimistic than those made by then-FDA Commissioner Margaret Hamburg in November. After meeting with Chinese regulators, Hamburg said the process of securing visas for a 26-strong office was entering the “homestretch.”
Now, with headcount down to the 13 in place at the time of Hamburg’s comments, FDA is shifting its focus to increasing the number of employees working in China for shorter durations, ranging from 60 to 120 days.
The Indian health ministry has initiated the long-discussed survey of drug quality in the country. Officials have tasked CDSCO inspectors with taking 47,000 samples from 5,000 pharma companies, wholesalers and other players in the supply chain.
India last ran such a survey in 2008, when inspectors collected 27,000 samples and concluded just 0.046% of the medicines in India were spurious. With other surveys putting the figure much higher — and estimates of fake drug prevalence in the West averaging 1% — the low percentage identified in the Indian government was met with skepticism.
Even so, Indian officials see value in having their own data to counter third-party claims and some people want to see surveys run more frequently. Dr. BR Jagashetty, former national advisor of drugs control to the ministry of health, told PharmaBiz: “Such a national survey needs to be mandated once in two years if not annually. It would also keep the pharma industry on guard.”
For now, the focus is on addressing the shortage of inspectors and strengthening punishments. The Hindu reports the government is aiming to have one inspector for every 50 manufacturing plants and hand out life sentences to anyone convicted of producing spurious drugs.
The Times of India, Deccan Chronicle, PharmaBiz, The Hindu
Novartis and Roche have stopped providing free early access to oncology drugs in Australia because the pace of approvals makes it prohibitively expensive. Both firms used to provide drugs for free in the gap between a product being cleared for sale and added to the Pharmaceutical Benefits Scheme.
However, with some drugs taking five years to advance between the different stages of approval and reimbursement, Roche has decided it is no longer “financially sustainable” to provide free access, The Australian reports. Roche and Novartis are both dropping the free model for a copay arrangement. Novartis is making patients cover 25% of the cost.
The sums involved are small for the companies — Novartis said it handed out drugs worth $12 million last year — but representative of the slow pace at which cancer drugs come to market in Australia. A Medicines Australia report ranked the country 18th out of 20 comparable nations in terms of access to medicines. Roche and Novartis commented on the topic at a Senate inquiry into the problem.
The Australian, Business Insider
Indian pharmaceutical companies are threatening to set up manufacturing plants and other units outside the country to lessen their exposure to its slow regulatory processes. The lack of defined timelines for clinical trials — a problem that has dampened Western enthusiasm for running studies in India — is the main gripe. Firms are considering responding by relocating plants. The Financial Express
China Food and Drug Administration (CFDA) has updated its good manufacturing practices (GMPs) for medical devices. The changes include 14 mandatory standards and 76 recommended processes. Law firm Covington & Burling LLP said the GMPs introduce pre-licensing inspections and self-audits, as well as set out how companies should organize their quality control systems. CFDA, Covington & Burling
An Indian parliament standing committee has called for all medicines to be brought under price control. “The committee was surprised to know that all medicines are not listed in the National List of Essential Medicines. The committee is of the view that all medicines are essential,” the authors wrote. The report also prioritizes the incentivizing of local production. Press Trust of India
India is pushing ahead with its track and trace plans. Exporters have until June 30 to comply with the policy, which was amended recently to mandate the linking of serialized packs to their respective cartons, cases and pallets. The Indian government is to gather the data in a central portal but is yet to provide details of the upload process and other technical requirements. SecuringIndustry
The Taiwan Food and Drug Administration has posted another list of drugs potentially contaminated with industrial grade magnesium carbonate. The list now features 19 producers of 23 over-the-counter drugs. Inspectors identified the use of industrial grade magnesium carbonate when they conducted a flurry of inspections earlier this month. BioSpectrum
The Japanese Ministry of Health, Labour and Welfare has put AbbVie’s hepatitis C combination drug ombitasvir/paritaprevir/ritonavir on its priority review program. Drugs on the program were reviewed almost twice as fast as those on the standard pathway in 2011. Timelines on both pathways have been trending down. Press Release
Tags: Regulatory Roundup, Asia Regulatory Roundup