Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Authorities in India have moved to strengthen policing of the safety and marketing of medical devices. The initiatives include a nationwide effort to gather data on the safety of medical devices, which the government is leading after the publication of reports of side effects associated with some products.
Officials at the health ministry plan to have the Indian Pharmacopoeia Commission coordinate the program, with Sree Chitra Thirunal Institute of Medical Sciences and Technology acting as the national collaboration center and CDSCO playing a supporting role. At first, 10 medical centers will report medical device-related adverse events online, but the program could expand, Times News Network reports.
News of the program leaked out at the same time as other details of the ongoing rethink of medical device regulation in India. The news included the confirmation by the government that the Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) applies to medical devices. UCPMP came into force at the start of 2015 to establish rules governing the relationships between companies and healthcare professionals, but until now it was unclear whether medical devices were under its authority .
The health ministry also agreed to found a committee focused on good manufacturing practices (GMP) for medical devices, a long-standing bugbear for the industry. Officials have tasked the committee with coming up with recommendations to improve the situation. – Nick Paul Taylor
Times News Network,PharmaBiz,More
The Center for Drug Evaluation at the China Food and Drug Administration has released its 2014 Annual Report of Drug Evaluation. The report covers the agency’s performance in evaluating medicinal products throughout 2014. The report shows the number of investigational new drug applications (IND) and new drug applications (NDA) remained close to previous years’ figures. The agency saw fewer applications for biological products.
The agency says the number of backlogged applications has increased from 14,235 at the end of 2013 to 18,597 at the end of 2014, an increase of 30%. Reuters reports that more stringent requirements at CFDA have contributed to the slowdown, with approval times ranging from six to eight years. – Michael Mezher
CFDA, Reuters
China is preparing to fill in a couple of gaps in its regulatory framework. The two initiatives cover the establishment of guidance to clarify the country’s stance on stem cells and the creation of regulations to stop medical device manufacturers from bypassing export procedures.
The device regulation is the more advanced of the two projects. China Food and Drug Administration (CFDA) released details of the draft policy late last week, telling the industry it plans to take tougher action against any company caught using fabricated data in medical device export applications. If the policy comes into force, CFDA will ban companies from reapplying for export certificates for two years and publicly name and shame people responsible for data fabrication schemes, Xinhua reports.
Details of the stem cell initiative are sketchier. China Securities Journal broke news of the initiative — which was then picked up by Want China Times — and stated it is expected to give a boost to the stem cell industry. China has a rich history of stem cell research but lacks a regulatory framework to help companies today. The plan is to create such a framework, which may be based upon guidelines from the International Society for Stem Cell Research. – Nick Paul Taylor
Xinhua, Want China Times
Portions of India’s Trademarks Act which establish the Intellectual Property Appellate Board (IPAB) have been ruled unconstitutional by the Madras High Court. The ruling found the selection of IPAB tribunal members does not meet legal standards in the country. Shamnad Basheer, who filed a writ petition against IPAB in 2011, covered the ruling for SpicyIP. The article also points out irregularities in the selection of some of IPAB’s technical members. One such member, the now retired Syed Obaidur Rahaman, claimed participation in a dozen cases (including one from 1899) that occurred before he was barred as an attorney in 1986. – Michael Mezher
SpicyIP
Senior Indian politicians have asked Prime Minister Narendra Modi to consider creating a government ministry dedicated to the pharmaceutical industry. Currently, the bodies tasked with regulating approvals and pricing are housed in different ministries.
Minister of Chemicals and Fertilisers Ananth Kumar began agitating publicly for a reorganization in November and has now enlisted the minister of state to help make the case to Modi. The plan is to create a new ministry that contains the Central Drugs Standard Control Organisation (CDSCO) and the National Pharmaceutical Pricing Authority (NPPA), which are currently housed in the Ministry of Health and Family Welfare and Ministry of Chemicals and Fertilisers, respectively.
Modi has already shown an appetite for such reorganizations. “As Prime Minister Narendra Modi created separate ministry for skill development and Ayush, on the same lines we will request him for separate Pharma Ministry,” Kumar told the Press Trust of India. If the government goes ahead with plans to create a separate regulatory body for medical devices, this unit could also be housed within the new ministry. – Nick Paul Taylor
Press Trust of India
The Japan News reports that a former Novartis Pharma K.K. employee admitted to falsifying the number of participants in a clinical trial for the drug Diovan. The former employee, Nobuo Shirahashi, is also alleged to have boosted the number of trials subjects who later developed diseases that were not treated with Diovan. Last year Novartis made headlines over accusations that the company failed to report side effects for two of its drugs; as a result the company is currently serving a 15-day suspension in Japan. – Michael Mezher
The Japan News
Pfizer has begun recalling all batches of multiple products in Australia after receiving complaints about the lack of childproofing technology on the packaging. The recall relates to Pfizer’s failure to use child-resistant caps on bottles of Xanax, Dostinex and other drugs.
Cabaser, Ponstan, Methoblastin and Halcion were also included by the recall, which unlike many such actions is tied to a systemic problem and as such covers all batches of the affected products. The use of child-resistant packaging for bottles of drugs that are toxic to children is mandatory in Australia.
No bottles of Cabaser, Dostinex, Halcion or Methoblastin featured such packaging. Pfizer also failed to include child-resistant caps on 50-tablet bottles of Ponstan and Xanax. To avoid the disruption of such a widespread recall, Australia’s Therapeutic Goods Administration (TGA) is recommending people take essential medicines affected by the recall to a pharmacy to swap the cap for a child-resistant version. – Nick Paul Taylor
TGA Notice, The Sydney Morning Herald
A court in Pakistan has issued a ruling suspending the country’s freeze on drug prices. The court found that the policy, which prevented companies from raising drug prices until July 2016, is unconstitutional and has suspended the freeze until a final ruling is made. The case was submitted to the court by the Pakistan Pharmaceutical Manufacturers Association (PPMA) and the Pakistan Chemist and Druggist Association (PCDA). Strict drug pricing restrictions have made drug prices in Pakistan some of the lowest in the world. – Michael Mezher
Daily Times
The China Food and Drug Administration (CFDA) is looking to strengthen its oversight of cosmetics sold in the country. The Global Times reports that the regulator will require companies to be able to track their products from production to sale, and issue reports on any adverse reactions that are observed.
CFDA, Global Times
Concerns over H1N1, also known as swine flu, are increasing in India. Researchers at the Massachusetts Institute of Technology (MIT) claim the strain of the virus is more severe than the strain found in the 2009-2010 outbreak. India’s National Institute of Virology denies the strain is more dangerous than previous versions of the virus. The International Business Times is reporting more than 30,000 cases and 1,700 deaths attributed to the virus. – Michael Mezher
MIT News, International Business Times
Singapore’s Health Sciences Authority (HSA) is warning consumers against eight products being illegally marketed. The products are all being labeled as sports or dietary supplements, but contain active ingredients that can cause serious side effects. The active ingredients identified are yohimbine, raubasine, vinpocetine, deanol and phenolphthalein. Both raubasine and deanol are not currently licensed for use by HSA. The agency is advising the public to be cautious when purchasing health products and avoid products that make dubious claims of “rapid weight loss.” – Michael Mezher
HSA Press Release
India’s National Pharmaceutical Pricing Authority (NPPA) is yet to recover more than $500 million it has requested from companies it accused of overcharging for drugs. Since NPPA began collecting fees for overcharging in 1997, the industry has paid back 9% of what the authority has demanded. Most of the money NPPA is seeking is subject to litigation. Press Trust of India
Humane Society International (HSI) is offering a reward to anyone who provides information about illegal animal testing of cosmetics in India that leads to a conviction. HSI set up the reward program and accompanying tipoff hotline to help the Drugs Controller General of India (DCGI) enforce the ban on testing cosmetics on animals in the country. Business Line
The Indian government is planning to introduce a mobile app to communicate information about drug pricing and availability, as well as details on the presence of substandard products. Officials released the outline of the app at an event to launch an online portal through which consumers can complain about the pricing and availability of drugs. Press Trust of India
CDSCO has begun recruiting 147 inspectors. If successful, the hiring spree will boost CDSCO’s ability to regulate the industry. However, only three of the positions are permanent, with the other 144 people being recruited on a temporary — but likely ongoing — basis. The Hindu
Tags: Asia Regulatory Roundup, Regulatory Roundup