Asia Regulatory Roundup: CFDA Offers New Drug, Device Draft Guidance (16 May 2017)

Posted 16 May 2017 By Nick Paul Taylor

placeholder+image

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

China Shares Flurry of Proposals to Encourage Drug, Medical Device Innovation

The China Food and Drug Administration (CFDA) has released four draft documents intended to encourage innovation in the drug and medical device industries. CFDA’s proposals aim to cut the time it takes to set up a clinical study, accelerate the approval process, overhaul the patent system and establish a risk-based approach to the oversight of trials.

Specific proposals in the four documents include the elimination of the need for sponsors to wait for the regulatory green light before starting a clinical trial. Today, sponsors file for clearance to run a trial and then wait for CFDA to approve the submission. Under the proposed model, sponsors can start the trial if CFDA fails to respond within 60 days. The proposal moves CFDA toward the model used by the United States Food and Drug Administration (FDA), which makes sponsors wait for 30 days after filing an investigational new drug application before starting a trial.

At 60 days, CFDA will still make companies wait longer than FDA, but the proposal make timelines predictable for the first time. The open-ended nature of the existing approach made it difficult for companies to plan. CFDA signaled its interest in moving to a 60-day model when it proposed a cancer pilot project with that timeline in 2015.

The rethink of the trial clearance process is one of a clutch of ways CFDA is proposing to revise its approach to clinical development. If the proposals come into force, CFDA will eliminate the clinical trial site accreditation system. Instead, potential trial sites will register online. This should lower the barrier to becoming a clinical trial site, enabling more hospitals and healthcare facilities to run research programs.

Other proposals will affect the drug approval process. CFDA is planning to allow companies to use clinical trial data generated overseas in registration applications. The regulator has also put out a statement that refers to conditional approvals and prioritization of innovative drugs and medical devices. CFDA put forward priority approval processes for certain drugs and medical devices last year. The latest statement reiterates its interest in accelerating the approval of promising products. 

The agency put out two other documents covering intellectual property and lifecycle management. The intellectual property document addresses how long products benefit from patent protection and the need for CFDA employees to ensure the confidentiality of information submitted by the industry. The lifecycle management draft covers topics including the need to improve the adverse event reporting system. CFDA has framed both texts as encouraging innovation, the same stated goal as the clinical trial and regulatory approval documents.

All the documents are open for comment until 10 June.

Trial Draft, Approval Draft, Patent Draft, Lifecycle Draft (all Chinese)

Lack of Consensus Forces India to Rethink Monitoring of Medical Device Prices

The National Pharmaceutical Pricing Authority (NPPA) of India has rethought its plan to monitor the prices of 19 medical devices. NPPA had proposed a new format for the collection of data, but has fallen back on a modified version of its drug price list in the face of a mixed response from the medical device industry.

Officials at NPPA discussed the data collection format it developed for the medical device sector at a series of meetings with a view to establishing a consensus and adopting a version that had the approval of all parties. That goal has proven to be impossible to achieve. NPPA said it found “that reaching a consensus on classification may not be possible due to diverse opinions about the classifications among the medical devices industries.”

That realization prompted NPPA to drop the format it had developed. Instead, NPPA is asking medical device manufacturers to provide pricing data on a modified version of form V, the document the cost watchdog uses to collect information from drug companies. The standard form V asks companies to provide the name and dosage forms of their formulations, the composition approved by drug controllers, the pack size, the price charged to retailers and the maximum retail price.  

Manufacturers of the 19 types of medical device affected by the ruling, which include hypodermic needles, heart valves and surgical dressings, have until May 31 to fill in the form and submit a hard copy to NPPA.

“Each company has to give the information as per all the medical devices it is selling in the market with all necessary details,” NPPA Adviser Kalyan Nag said. 

NPPA Memo

Indian Politicians Discuss Empowering NPPA to Control Prices of More Medical Devices

Indian politicians have met with the chairman of NPPA to discuss how to control the prices of more medical devices. A parliamentary committee called the chairman to discuss a petition it received about controlling the “exorbitant prices” of medical devices, including hip and knee implants.

NPPA is still trying to enforce its recently implemented price cap on cardiac stents and sort out how to monitor the prices of other devices under its jurisdiction, but politicians are looking beyond these products to other medical technologies. The petitions committee of one house of the Indian parliament called the NPPA chairman and other interested parties to a meeting last week to talk about how to rein in prices of a broader range of devices.

The meeting agenda refers to hip and knee implants, but according to The Economic Times, the committee is looking at a broader range of products. This focus reflects the demands of people who have given evidence to the politicians.

“We also want price control of other devices such as pacemakers, cochlear implants and artificial joints,” Dr Ravi D’Souza, who works at community health resource center Sochara, said.

Other commentators are keen for NPPA to further lower the cost of cardiac procedures by bringing the cost of catheters, balloons and guidewires under control. The reasoning is that, while the stent cap addressed one driver of high prices, the lack of controls covering other products means there is still scope to make cardiac procedures more affordable.

Meeting Agenda, The Economic Times

TGA Clarifies Rules for Advertising Cosmetic Procedures That Use Prescription Drugs

The Therapeutic Goods Administration (TGA) of Australia has clarified its stance on the advertising of cosmetic services that use prescription-only medicines. Such services can fall foul of regulators as, while it is legal to advertise the procedure, promotion of prescription medicines is prohibited. 

TGA has released a statement to help cosmetic service providers navigate this landscape. The note from TGA clarifies that it is illegal to advertise prescription medicines such as Allergan’s Botox that are used in cosmetic procedures. Failure to comply with this rule can trigger fines of AU$54,000 ($40,000) for organizations and AU$10,800 for individuals. That restriction does not stop people from advertising services that use these drugs, though.

To promote services without breaching the rules, TGA recommends organizations refrain from referring to the prescription drugs they use. The prohibition on the advertising of prescription drugs extends to a ban on the use of “acronyms, nicknames or abbreviations” that refer to either the brand or chemical name of the product.

Instead of referring to the drug directly, advertisers should use generic terms such as “cosmetic injections,” “anti-wrinkle injections” and “treatments for fine lines.” Such terms are acceptable under TGA’s advertising rules.  

TGA Statement

Share this article:

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

Tags: CFDA guidance, medical device prices in India, Australia drug ads

Regulatory Exchange: Latest Updates From the Community