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 email@example.com 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.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 18 November 2014 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting Asia and the companies operating therein.
The Indian government is preparing to clamp down on overcharging for essential medicines by making it mandatory to list the price it sets on the packaging. If final discussions with manufacturers, state regulators and other groups go according to plan, the requirement could come into force on 1 January 2015.
India’s National Pharmaceutical Pricing Authority (NPPA) is leading the initiative to add bold red stripes and government-set prices to the labels of all essential medicines, The Times of India reports. NPPA thinks the requirement will increase consumer awareness of which drugs it regulates and how much they should cost.
The proposal is part of NPPA’s strategy to stop companies overcharging for essential medicines. NPPA is currently reviewing multiple allegations of overcharging, but thinks many more cases are going undetected. Giving every consumer the information they need to identify cases of overcharging — instead of relying on random sampling by inspectors — could help NPPA better control the situation.
Pharmaceutical manufacturers have until the end of November 2014 to comment on the proposal, the release of which coincided with news NPPA wants to bring another 100 drugs under its authority. Last time NPPA tried to bring drugs outside the National List of Essential Medicines under price control it met with fierce opposition, culminating in a court hearing and the withdrawal of the proposal.
The new plan covers different combinations and dosages of drugs already controlled by NPPA. For example, NPPA currently only caps the price for one strength of paracetamol and certain dosage forms of the antiretrovirals nelfinavir and ritonavir. If its proposal is approved, multiple strengths and dosage forms will be brought under price control.
Times of IndiaI More
China and the United States are on the cusp of clearing long-standing obstacles to regulatory and business interactions. US Food and Drug Administration (FDA) Commissioner Margaret Hamburg is going to China to finalize agreements on visas for inspectors, while trade negotiators have agreed to end tariffs on medical devices.
The visa issue has held back FDA’s expansion in China for two years, but the agency is now optimistic an agreement is in sight. A representative told Reuters the visas should be approved “in the coming weeks and months.” FDA is also talking to CFDA about oversight of active pharmaceutical ingredients (APIs). CFDA currently regulates APIs as chemicals, not drugs.
FDA wants this to change. “There may be changes in that regulatory arrangement. We think that API is a critical component for which the CFDA should play a more active role,” Hamburg told China Daily.Oversight of APIs will sit alongside visas for FDA staff, facility inspections and the drug review process on the agenda when Hamburg meets with CFDA.
The talks follow a breakthrough in US-China trade relations. Negotiators have agreed to expand the World Trade Organization’s (WTO) Information Technology Agreement (ITA) to cover medical devices. “Agreement on expanding the ITA would be the first successful tariff-cutting negotiation in the WTO for over a decade and a half,” WTO Director-General Roberto Azevêdo said in a statement.
ReutersI China DailyI Press Release
An investigation into the deaths of 13 women during a sterilization drive has identified contaminated antibiotics as a possible cause of the events. Indian officials are probing a facility run by Mahawar Pharmaceuticals as part of an investigation that has raised doubts about regulatory oversight in the state of Chhattisgarh.
Reuters reports regulators shut down the production plant and seized 28,000 tablets of ciprocin last week, but by then two men had been seen lighting a fire behind the facility. Packets of ciprocin and other drugs were reportedly found in the fire. A chemical used in rat poison was found in preliminary tests of ciprocin from the plant, but the manufacturer had denied selling contaminated drugs.
Mahawar Pharmaceuticals has faced regulatory sanctions in the past, The Times of India reports. From 2010 to 2012, the state government issued eight bans against drugs manufactured by the company because of quality defects. The company was also convicted of selling “duplicate generic medicines” in 2012.
Despite these problems, the state health department continued to buy drugs from the company and local regulators awarded the plant good manufacturing practice status in May. Now, the Chhattisgarh government is saying the plant lacks qualified staff and violates manufacturing norms as it is located in a residential neighborhood.
ReutersI Times of IndiaI New York Times I More
CFDA plans to create a new regulatory pathway for vitamins and minerals as part of an overhaul of its approach to the health food industry. Currently, all nutritional supplements must go through the long, expensive “blue hat” regulatory approval process.
In two draft documents, CFDA has outlined how it plans to simplify the system for vitamins and minerals. “It is a step in the right direction and there will be further development in the years to come. China is taking this industry very seriously and is conservative in its approach,” Jeff Crowther, executive director of the U.S.-China Health Products Association, told FoodNavigator-Asia.
Crowther said the new approach could come into force next year. The proposal is part of a broader rethink of health food regulations, a process which has seen CFDA officials talk to overseas regulators about the topic for the first time. CFDA is also trying to stop false advertising of health products. This week it promised to severely punish offenders.
FoodNavigator-AsiaI CFDA Notice (Chinese)
Japan’s Pharmaceutical and Medical Devices Agency (PMDA) is set to begin enforcing new medical device regulations on 25 November. The new rules require marketing authorization holders to have representatives in Japan. In a separate development, PMDA approved Medtronic’s Evera MRI SureScan, while across the Sea of Japan Korean regulators cleared Presbia’sFlexivue Microlens.
Med Device Online I Medtronic I Presbia
Indian pharmaceutical associations have come out against the government’s plan to ban polyethylene terephthalate (PET) in certain packaging. The organizations are willing to take their case to the courts, which have rejected anti-PET public interest litigations in the past. PharmaBiz
Australia’s Therapeutic Goods Administration (TGA) has agreed to adopt another batch of European guidelines. The newly adopted regulations cover the quality of oral modified release products and an array of International Conference on Harmonisation texts. TGA Notice
An intellectual property think tank proposed by the Indian government has met immediate opposition from foreign drug developers. The main concern for Western companies is the lack of representatives from innovative pharmaceutical firms on the panel. The Economic Times
CFDA has published a list of drugs that it views as being produced by too many different companies. The list is intended to stop manufacturers from entering congested sectors — such as the market for vitamin B12 — and instead focus their resources on areas of unmet need. CFDA Notice (Chinese)
The Association of Indian Medical Devices Industry (AIMED) has formed a memorandum of understanding with the National Accreditation Board of Certifying Bodies and Quality Control of India. The agreements are part of a move by AIMED toward self-certification. PharmaBiz
Tags: Asia Regulatory Roundup, Regulatory Roundup