Asia Regulatory Roundup: TGA Rewrites Rules on Advisory Committee Conflicts of Interest
Regulatory News | 08 May 2018 |
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Rewrites Rules on Conflicts of Interest, Confidentiality Obligations
The Therapeutic Goods Administration (TGA) of Australia has overhauled the conflict of interest rules and confidentiality obligations that apply to members of its advisory committees. TGA made the changes to bring the text in line with best practices and accessibility requirements.
In creating version 2.0 of the guidance, TGA has made major changes to the content and structure of the text. The result is a document that explains the significance of actual or perceived conflicts of interest before walking committee members through the interests they must declare and the process for doing so.
TGA expects committee members to declare the interests of their “immediate families” — the exact definition of which varies from person to person — and their direct and indirect links to companies. These links include everything from the ownership of shares to participation in clinical trials. TGA also wants to hear about less tangible sources of conflict of interest, such as strong religious beliefs.
People need to share details of conflicts of interest when they apply to join a committee and make annual declarations thereafter. TGA also expects members to declare conflicts whenever they are relevant to an item on the committee’s agenda, even if they have already been stated in the annual filing.
Members can exclude some conflicts, such as religious beliefs, from their annual submissions and instead declare them when the committee deals with an item of relevance to the interest. If a person becomes aware of a conflict during a meeting, they should tell the chair immediately.
Whenever a conflict is relevant to an item on the agenda, the committee member can volunteer to abstain from participating in the discussion of the matter. If the person opts not to abstain, the other members of the committee will discuss how to handle the situation in their absence. The committee can make a range of rulings, from permitting their full participation to total exclusion.
TGA’s guidance also addresses the confidentiality obligations of members, who must sign a deed stating they will not directly or indirectly disclose secrets or use them outside their position on the committee.
The changes are the first edits TGA has made to the guidance since 2016. That change and preceding updates made minor tweaks to the original version TGA released in 2011, but left the core structure and content unchanged.
TGA Guidance
CDSCO Moves Regulatory Processes for New Drugs to Online Portal
The Central Drugs Standard Control Organization (CDSCO) has taken a big step in its transition from paper to online processes. Thirty months after setting up the online Sugam portal, CDSCO is moving applications related to new drugs over to the system.
CDSCO committed to the digital strategy under the previous Drugs Controller General of India (DCGI), who saw the technology as a way to bring consistency to regulatory timelines while controlling costs. Now, the latest DCGI, S. Eswara Reddy, is overseeing the expansion of the portal to cover some of the key regulatory processes that still use paper.
The latest stage of the staggered, multi-year rollout of the portal covers modules for new drugs, subsequent new drugs and fixed-dose combinations. A notice by Reddy disclosing the introduction of the modules made no mention of the timeline for the switch.
CDSCO encountered some problems in rollouts of earlier modules. Groups including sponsors and contract research organizations complained about multiple modules of the portal in 2016. That year, the DCGI told the external group developing Sugam to turn it into a “flawless operational platform.”
DCGI Notice
TGA Seeks Feedback on Proposed Process for Handling Complaints About Advertising
TGA has proposed a procedure for handling complaints about the advertising of therapeutic goods. The agency created the process and opened it up for feedback in anticipation of becoming the single body responsible for managing complaints in July.
Faced with these responsibilities and empowered by new sanctions, TGA has considered how best to source, triage and investigate complaints. The resulting model categorizes complaints in one of four priority levels, which dictate how TGA approaches the investigation of the case and punishment of the organization behind the advertisement.
TGA wants people to submit complaints via an online form, but it will also accept submissions by email, telephone or mail. Upon receiving a complaint, TGA will assess whether it is valid and within its jurisdiction.
Complaints that meet both these criteria will advance to triage, when TGA staff will assess the intent of the advertiser, potential for harm and other factors before assigning a priority to the case. For example, if an ad is directed at vulnerable groups or undermines public health messages, TGA will class it as a critical case. In contrast, accidental, one-time breaches with limited consequences will be classed as low priorities.
The classification will dictate how the complaint is handled. TGA plans to approach the contact person at organizations involved in critical cases immediately. If needed, TGA will also apply for court injunctions, cancel registrations and use other powers intended to minimize the harm caused by the ad.
TGA will respond more slowly to smaller discretions and order milder responses. These responses include the use of guidance and education and training materials. TGA is working on an e-learning program to support this side of its enforcement regime. The agency also plans to create guidance documents.
TGA Consultation
India Bans Private Companies from Manufacturing Oxytocin for Domestic Use
India has prohibited the production of oxytocin for domestic use by private companies. By restricting access to the local market to publicly owned enterprises, officials hope to finally stop the misuse of the hormone.
Under the rules, which are set to come into force in July, private sector companies can only produce oxytocin for sale overseas. To help enforce this restriction, the rules also ban manufacturers of active pharmaceutical ingredients (APIs) from selling oxytocin to private companies unless they know the finished product is destined for export.
The restrictions put public sector organizations in control of the domestic market. These enterprises may produce oxytocin for local use — and receive shipments from API suppliers — but can only supply the drug directly to registered hospitals or clinics and certain government entities. The rules ban retail chemists from selling any form of oxytocin.
India proposed the restrictions shortly after mandating the use of barcodes on oxytocin. The latest rules reflect this earlier proposal, stating that all oxytocin manufactured, whether for local use or export, must carry a barcode.
The proposals follow continued reports of the misuse of oxytocin by dairy farmers and meetings between regulators and manufacturers of the hormone.
Gazette Notification
Other News:
India has revised its proposed rules on the use of warning labels on drug packaging in response to feedback. Officials released the original draft rules for consultation in November, before revising and republishing them in light of the responses they received. The revised document is now open for consultation. The plan is to bring the rules into force at the start of November. Gazette Notification
A third notified body has registered with CDSCO. The registration of the notified body, TÜV SÜD South Asia, comes amid reports the fee structure proposed by CDSCO is deterring testing groups from signing up. CDSCO Notice
TGA Rewrites Rules on Conflicts of Interest, Confidentiality Obligations
The Therapeutic Goods Administration (TGA) of Australia has overhauled the conflict of interest rules and confidentiality obligations that apply to members of its advisory committees. TGA made the changes to bring the text in line with best practices and accessibility requirements.
In creating version 2.0 of the guidance, TGA has made major changes to the content and structure of the text. The result is a document that explains the significance of actual or perceived conflicts of interest before walking committee members through the interests they must declare and the process for doing so.
TGA expects committee members to declare the interests of their “immediate families” — the exact definition of which varies from person to person — and their direct and indirect links to companies. These links include everything from the ownership of shares to participation in clinical trials. TGA also wants to hear about less tangible sources of conflict of interest, such as strong religious beliefs.
People need to share details of conflicts of interest when they apply to join a committee and make annual declarations thereafter. TGA also expects members to declare conflicts whenever they are relevant to an item on the committee’s agenda, even if they have already been stated in the annual filing.
Members can exclude some conflicts, such as religious beliefs, from their annual submissions and instead declare them when the committee deals with an item of relevance to the interest. If a person becomes aware of a conflict during a meeting, they should tell the chair immediately.
Whenever a conflict is relevant to an item on the agenda, the committee member can volunteer to abstain from participating in the discussion of the matter. If the person opts not to abstain, the other members of the committee will discuss how to handle the situation in their absence. The committee can make a range of rulings, from permitting their full participation to total exclusion.
TGA’s guidance also addresses the confidentiality obligations of members, who must sign a deed stating they will not directly or indirectly disclose secrets or use them outside their position on the committee.
The changes are the first edits TGA has made to the guidance since 2016. That change and preceding updates made minor tweaks to the original version TGA released in 2011, but left the core structure and content unchanged.
TGA Guidance
CDSCO Moves Regulatory Processes for New Drugs to Online Portal
The Central Drugs Standard Control Organization (CDSCO) has taken a big step in its transition from paper to online processes. Thirty months after setting up the online Sugam portal, CDSCO is moving applications related to new drugs over to the system.
CDSCO committed to the digital strategy under the previous Drugs Controller General of India (DCGI), who saw the technology as a way to bring consistency to regulatory timelines while controlling costs. Now, the latest DCGI, S. Eswara Reddy, is overseeing the expansion of the portal to cover some of the key regulatory processes that still use paper.
The latest stage of the staggered, multi-year rollout of the portal covers modules for new drugs, subsequent new drugs and fixed-dose combinations. A notice by Reddy disclosing the introduction of the modules made no mention of the timeline for the switch.
CDSCO encountered some problems in rollouts of earlier modules. Groups including sponsors and contract research organizations complained about multiple modules of the portal in 2016. That year, the DCGI told the external group developing Sugam to turn it into a “flawless operational platform.”
DCGI Notice
TGA Seeks Feedback on Proposed Process for Handling Complaints About Advertising
TGA has proposed a procedure for handling complaints about the advertising of therapeutic goods. The agency created the process and opened it up for feedback in anticipation of becoming the single body responsible for managing complaints in July.
Faced with these responsibilities and empowered by new sanctions, TGA has considered how best to source, triage and investigate complaints. The resulting model categorizes complaints in one of four priority levels, which dictate how TGA approaches the investigation of the case and punishment of the organization behind the advertisement.
TGA wants people to submit complaints via an online form, but it will also accept submissions by email, telephone or mail. Upon receiving a complaint, TGA will assess whether it is valid and within its jurisdiction.
Complaints that meet both these criteria will advance to triage, when TGA staff will assess the intent of the advertiser, potential for harm and other factors before assigning a priority to the case. For example, if an ad is directed at vulnerable groups or undermines public health messages, TGA will class it as a critical case. In contrast, accidental, one-time breaches with limited consequences will be classed as low priorities.
The classification will dictate how the complaint is handled. TGA plans to approach the contact person at organizations involved in critical cases immediately. If needed, TGA will also apply for court injunctions, cancel registrations and use other powers intended to minimize the harm caused by the ad.
TGA will respond more slowly to smaller discretions and order milder responses. These responses include the use of guidance and education and training materials. TGA is working on an e-learning program to support this side of its enforcement regime. The agency also plans to create guidance documents.
TGA Consultation
India Bans Private Companies from Manufacturing Oxytocin for Domestic Use
India has prohibited the production of oxytocin for domestic use by private companies. By restricting access to the local market to publicly owned enterprises, officials hope to finally stop the misuse of the hormone.
Under the rules, which are set to come into force in July, private sector companies can only produce oxytocin for sale overseas. To help enforce this restriction, the rules also ban manufacturers of active pharmaceutical ingredients (APIs) from selling oxytocin to private companies unless they know the finished product is destined for export.
The restrictions put public sector organizations in control of the domestic market. These enterprises may produce oxytocin for local use — and receive shipments from API suppliers — but can only supply the drug directly to registered hospitals or clinics and certain government entities. The rules ban retail chemists from selling any form of oxytocin.
India proposed the restrictions shortly after mandating the use of barcodes on oxytocin. The latest rules reflect this earlier proposal, stating that all oxytocin manufactured, whether for local use or export, must carry a barcode.
The proposals follow continued reports of the misuse of oxytocin by dairy farmers and meetings between regulators and manufacturers of the hormone.
Gazette Notification
Other News:
India has revised its proposed rules on the use of warning labels on drug packaging in response to feedback. Officials released the original draft rules for consultation in November, before revising and republishing them in light of the responses they received. The revised document is now open for consultation. The plan is to bring the rules into force at the start of November. Gazette Notification
A third notified body has registered with CDSCO. The registration of the notified body, TÜV SÜD South Asia, comes amid reports the fee structure proposed by CDSCO is deterring testing groups from signing up. CDSCO Notice
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