Asia Regulatory Roundup: J&J, Novartis and Pfizer Comment on Australian Risk Management Proposals (28 February 2017)

Posted 28 February 2017 By Nick Paul Taylor

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Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

J&J, Novartis and Pfizer Comment on TGA Risk Management Proposals

Johnson & Johnson, Novartis and Pfizer say they are broadly in favor of the Therapeutic Goods Administration’s (TGA) proposed framework for risk-management plans, but have some specific suggestions as to how it can be improved.

TGA released version 3.0 of its guidance on risk management plans for medicines and biologicals for consultation late last year. The text expanded on the current guidance for medicines by adding references to biologicals and biovigilance, as well as a new section based on the EU’s approach to advanced therapy medicinal products. In doing so, TGA sought to create a document tailored to preparing risk management plans for Class 2, 3 and 4 biologicals.

None of the respondents were particularly critical of the guidance, although Novartis said it only “partially” agrees with the text. Novartis foresees disconnects between TGA’s proposal and the situation in the EU creating administrative challenges. As such, Novartis recommends TGA accepts the EU risk management plans for products that align with European guidelines on good pharmacovigilance practices, and creates an Australian-specific annex covering additional requirements.  

Pfizer also has concerns about the challenge and burden of implementing the requirements. The company’s response picks out the need to justify whenever the risk management plan is not updated in line with changes to the product information as unnecessarily onerous. Pfizer is also skeptical of the value of TGA’s stance on updating the Australian Specific Annex.

J&J has different qualms with the text. Notably, it recommends a more risk-based approach to the education of healthcare professionals. As J&J sees it, it is “unreasonable” to make sponsors run educational programs for classes of medicines that are well established. When the risks of a class of medicines are well known, J&J recommends TGA takes a pragmatic approach that avoids wasted effort and does not annoy “the prescribing doctors who feel their intelligence is being questioned.” 

Novartis’ response also covered guidance on the biovigilance responsibilities of sponsors, a text that was put out for consultation in conjunction with the risk-management document. The Swiss pharma is more wholehearted in its support of the biovigilance guidance, but sees some potential barriers to its implementation.

“It will be challenging for sponsors to meet the traceability measures to track the product down to the patient and others in the healthcare setting who have come into contact with the biological. There will need to be collaboration across sectors including hospitals, pharmacies, wholesalers and sponsor companies. TGA would need to have a collaborating and supportive role in developing traceability measures in many instances,” Novartis wrote in its feedback.  

TGA Notice

India Achieves 100% Compliance in WHO Assessment of Regulatory System

The World Health Organization (WHO) has found the Indian vaccine regulatory system to be 100% compliant. WHO awarded the Indian authorities the highest possible maturity level in five of the nine areas assessed, a sharp improvement over the last time the system was reviewed in 2012.

Back then, WHO was prequalifying India to supply vaccines to international procurement agencies for the first time. That assessment looked at seven areas of India’s regulatory capacity. WHO gave passing grades to four functions at the first time of asking, and the remaining three during a follow up six months later.

This time, India has received passing grades in all nine categories first time. WHO handed out level four scores — the highest grade — in five of the nine functions assessed. The score indicates good, improving results. India received level three — the next rung down — in the remaining four areas. WHO awards level three scores when it sees early evidence of systematic improvements and a process-based approach.

“The successful assessment will go a long way in strengthening global confidence in medicinal products from India and also give an impetus to the ‘Make in India’ mantra,” Dr. Poonam Khetrapal Singh, WHO regional director for South-East Asia, wrote in a letter to the Indian minister of health.

WHO made the rulings after its inspectors assessed the performance of the Central Drugs Standard Control Organization (CDSCO), Pharmacovigilance Programme of India (PvPI) and other regulatory institutions against its global benchmarking tool. The tool looks at 63 indicators and 288 sub-indicators — 150 of which are classed as critical — to gauge the maturity of regulatory authorities.      

Press Release, WHO Letter

NPPA Tells Manufacturers to Restructure Supply Channels to Cope with Stent Price cap

The National Pharmaceutical Pricing Authority (NPPA) of India has told manufacturers of cardiac stents to restructure their “trading and supply channel” to cope with the new cap on their profit margins. NPPA thinks this will enable companies to cope with the 8% maximum trade margin.

Manufacturers and other players in the Indian cardiac stent supply chain had questioned whether the ceiling price set by NPPA covered everything except local sales taxes and VAT. NPPA clarified that an 8% trade margin is built into its price cap and, as such, non-tax-related additional charges are prohibited. The price watchdog then followed up with a statement telling stent manufacturers to change up their operations to work within the 8% trade margin.

The back and forth is part of the ongoing fallout from NPPA’s long-awaited decision to cap the price of drug eluting and bare metal stents in India. NPPA has maintained a running commentary regarding the situation on Twitter. The organization's posts include the names of hospitals accused by third parties of overcharging for stents, and details of what NPPA is doing in response.

In one case, NPPA has enlisted the Maharashtra Food and Drug Administration to investigate. In others, NPPA has sent show cause notices asking hospitals to respond to complaints made against them. NPPA will drop its investigations if hospitals that have overcharged issue refunds to patients. If the overcharging stems from stent manufacturers failing to lower their prices, NPPA has vowed to go after them, too.    

After posting a stream of complaints last week, NPPA said it received no reports of overpricing on Monday.

NPPA Notice, The Economic Times

India Approves First Quadrivalent flu Vaccine

Indian regulators have approved Zydus Cadila’s quadrivalent flu vaccine, VaxiFlu - 4. The product is the first quadrivalent influenza vaccine to win approval in India.

Zydus Cadila received clearance to sell the vaccine in India from CDSCO, the Drug Controller General of India and the Central Drug Laboratory. Those decisions mean India has now followed the US and EU in approving a quadrivalent flu vaccine.

Like other quadrivalent influenza vaccines, VaxiFlu - 4 is designed to provide protection against two subtypes of influenza A and two subtypes of influenza B. Older, trivalent vaccines only cover one subtype of influenza B, increasing the risk they will fail to protect people against the virus strains circulating in a particular flu season.

The quadrivalent vaccine was developed by the group behind Vaxiflu-S, the first H1N1 vaccine to be created in India.

Press Release

Other News:

China Food and Drug Administration (CFDA) is seeking feedback on a notice about the re-registration of drugs. CFDA Notice (Chinese) 

CFDA has released a notice about the implications of the end of the transition period for implementation of good manufacturing practices. CFDA Notice (Chinese)

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Regulatory strategy, Regulatory intelligence, News, Asia, CFDA, CDSCO, TGA

Tags: Asia Regulatory Roundup, Pfizer, J&J, Novartis, stents

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