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.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 18 April 2017 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
India has convened a committee to consider reforms to drug pricing legislation and the agency that enforces the rules. Officials at the Department of Pharmaceuticals took the step in response to feedback from regulators and industry about the shortcomings of the existing pricing legislation and mechanisms.
The committee will look at six points, the breadth of which position it to make recommendations that would dramatically change the drug pricing landscape in India. At the top of the list of priorities for the committee is the consideration of measures “for making pricing policy more in favor of poor patient’s affordable medical and health security.”
Other areas being investigated by the committee are similarly broad. Members of the six-person committee will review the scope of the current Drugs (Price Control) Order (DPCO), 2013 and “suggest ways for strengthening the regulatory provisions of the order.” The government also wants the panel to propose ways to make DPCO “more comprehensive in light of past experience.”
While many of the priority areas are aimed at strengthening regulations and price controls, the list also features topics that could lead to changes beneficial — or at least benign — to the industry. One of the more defined questions facing the committee is how to make the process of collecting drug price data more streamlined and robust while also strengthening the existing pharmaceutical database management system.
The government has also tasked the committee with looking at how to improve processes at the National Pharmaceutical Pricing Authority (NPPA). Specifically, the government wants NPPA to more quickly, effectively and transparently implement its policies. The overarching goal is to reduce the number of legal actions and review petitions aimed at NPPA.
To achieve this goal, the government plans to draft detailed standard operating practices (SOPs) covering certain regulatory functions, including how the prices of medicines are set, monitored and enforced. The proposed SOPs will also address “action against pharmaceutical companies in overpricing cases.”
Drug Controller General of India (DCGI) Dr GN Singh is one of the committee members. The rest of the panel is made up of senior officials from the government, NPPA and the National Health System Resource Centre. Trade groups and other organizations affected by drug pricing can send comments and suggestions until 1 May.
Public Notice
China Food and Drug Administration (CFDA) has revised its position on the handling of cases of clinical trial data fraud in response to feedback. CFDA has accepted some of the changes proposed in the 280 pieces of feedback it received, but has rejected three significant suggestions.
The regulator received a lot of feedback in the month the draft was open for comment last year, and has made changes in six main areas in response to the suggestions. Changes made by CFDA include the adjustment to the period clinical trial sites have to rectify fraud cases and the creation of a special procedure for companies facing clinically urgent situations.
CFDA was less amenable to some other comments. The regulator rejected requests to only punish clinical trial sites and individuals in cases of clinical trial fraud, instead of also taking action against the company that sponsored the study and submitted the subsequent application. In knocking back this request, CFDA pointed to laws and regulations that place the onus on applicants to ensure the data they submit are legitimate.
The regulator also rejected requests to be more lenient when the fraudulent data makes up a small proportion of the overall dataset. CFDA dismissed the suggestion on the grounds that any evidence of data fraud casts doubt on the legitimacy of the rest of the results and that it thinks legislation supports its original position. The third rejected request related to the proposed blacklist. CFDA is unwilling to compromise on the transparency of the blacklist.
CFDA has released the revised draft for a brief comment window. The regulator is accepting feedback until 21 April.
CFDA Notice (Chinese)
China has outlined a marketing push intended to improve public perceptions of its regulation of the food and drug industries. Senior government officials want regional CFDA staffers to share photographs and short videos that present frontline regulatory activities in a way likely to find favor with the public.
A state-owned health media organization is coordinating the initiative in collaboration with CFDA press officials. The plan is to create marketing materials that show the work CFDA does to ensure the quality, safety and efficacy of products. Specifically, the media groups organizing the project want to generate photographs and videos of no more than five minutes that tell stories about the work regulatory teams do to protect the public.
Responsibility for generating content will fall, in part, on CFDA employees. The team running the project will review works submitted by CFDA staff and include suitable photographs and videos in campaigns on popular Chinese messaging service WeChat, publications run by the state-owned media group and CFDA’s website. Content created by CFDA employees will run alongside work from journalists and others with a link to food and drug regulation.
Publication of the plan comes one year after outcry over the regulatory shortcomings that enabled an illegal vaccine ring to operate undetected for years damaged the reputation of CFDA. At the time, CFDA Deputy Director Wu Zhen, the World Health Organization and others sought to allay concerns about the safety of vaccines and the competence of the regulator. Separately, CFDA has stepped up its online activities in recent years in an attempt to better shape public narratives.
Australia has introduced legislation on the publication of information relating to laboratory testing. The document sets rules about what information the Therapeutic Goods Administration (TGA) can release to the public with a view to increasing transparency.
In this context, laboratory testing refers to several activities undertaken by TGA. Batch release testing of biological medicines, proactive assessments of compliance and investigations begun in response to triggers such as adverse events are all covered by the legislation.
Under the terms of the legislation, TGA will publish information on its laboratory testing activities twice a year. The regulator will wait at least six months after completing a test before releasing details. This delay is intended to give TGA time to investigate and act against discoveries of noncompliance.
Lawmakers see the document as complementary to existing processes covering the release of information relating to safety alerts, product recalls and adverse events. Also, the document is intended to bring TGA’s approach to the publication of laboratory testing information more in line with practices in the European Union and United States.
The text passed into law without first going through a formal consultation, although TGA has discussed the plan through a variety of forums. The path of the text into law was simplified by the fact it will not place additional burdens on sponsors.
TGA Notice, Legislation
Tags: Asia regulatory roundup, India drug pricing, CFDA clinical trial, China drug regulations
Regulatory Focus newsletters
All the biggest regulatory news and happenings.