Asia Regulatory Roundup: India Schedules Weeks of Hearings to Discuss Proposed FDC Bans

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
 
India Schedules Weeks of Hearings to Discuss Proposed FDC Bans
 
India has scheduled weeks of meetings to hear the views of companies affected by the proposed ban on fixed-dose combination (FDC) drugs. The intense schedule will give manufacturers of hundreds of FDCs a chance to argue that their products are rational and should be allowed to stay on the market.
 
Starting this week, the Drugs Technical Advisory Board (DTAB) will hold hearings on up to 40 FDCs a day. The daily hearings, which DTAB will hold from 9:30 a.m. to 7 p.m., will run until 22 June. Such an intense schedule is required to ensure the producers of the 344 banned FDCs can make their case to DTAB, as is required under the Supreme Court ruling that tasked the advisory board with examining the products.
 
DTAB is seeking to make the hearing schedule manageable by asking manufacturers to ensure their presentations are “to the point.” The board has set the days on which each FDC will be discussed and given manufacturers relatively little notice ahead of the first round of hearings. If a manufacturer fails to give a presentation, DTAB will rule on the FDC based on the information that is available.
 
The advisory board has also sourced written submissions from companies. The extended deadline for the submission of hard and soft copies of information to support FDCs passed this week. With the hearing schedule due to end later this month, DTAB will soon have the information it needs to make rulings on all the FDCs. However, the large number of FDCs the advisory board needs to assess means it could be some time before rulings are issued.
 
The saga has already dragged on for more than two years. The Indian government moved to ban the products in March 2016 on the grounds that there is no therapeutic justification for the combinations of drugs. Manufacturers immediately pushed back against the ban, leading to the Supreme Court ruling that tasked DTAB with forming an expert subcommittee to reconsider the safety and efficacy of the FDCs.
 
DTAB Notice
 
TGA Brings Advertising Guidance in Line with Latest Legislation
 
The Therapeutic Goods Administration (TGA) of Australia has posted new advertising guidelines in response to recent legislative changes. The guidelines bring TGA’s position in line with the legislative commitment to stop requiring the pre-approval of certain advertisements in 2020.
 
Australian lawmakers amended the Therapeutic Goods Act 1989 in March to signal the beginning of the end for pre-approval. Lawmakers had planned to move to the new, self-regulatory approach next month, but ultimately pushed the date back in response to pressure from consumers. With two years until the switch, TGA plans to use the time to prepare advertisers for the new way of working.
 
TGA has indicated it plans to provide companies with “clear guidance and the required information to achieve compliant advertising” before moving to the new model in 2020. Beyond that, TGA will end pre-approval, although firms will need the agency’s permission to use restricted representations in advertisements.
 
Restricted representations are one of four topics on which TGA is still developing guidance. These documents are referred to in the guidelines released this week, but TGA is yet to flesh out its thinking on the topics. The other three topics cover advertising different types of therapeutic goods, forms an advertisement may take and the interface between consumer goods and medicines.
 
The latest guidelines also reflect the new powers granted to TGA by the recent legislative changes. As a result of the act, TGA has more ways to enforce the advertising rules, including a new tiered approach to criminal prosecutions. Lawmakers drafted the approach to better link sanctions to the severity of the wrongdoing. 
 
Publication of the guidelines comes at a time when TGA is reviewing the Australian advertising code for therapeutic goods. The guidelines are based on the 2015 version of the code. TGA is still working on the 2018 version and plans to start a consultation on it later this month. 
 
TGA Guidelines
 
Malaysia Adopts Conditional Approval Guidelines to Fast Track Drugs
 
Malaysia has adopted guidelines on the conditional approval of biologics and small molecules. The National Pharmaceutical Regulatory Agency (NPRA) created the guidelines to enable companies to get drugs to patients on the strength of Phase II safety and efficacy data.
 
As with conditional approval pathways around the world, Malaysia’s NPRA designed its policy to cut the time it takes for certain particularly promising therapies to reach patients. The pathway is open to developers of drugs that serve an unmet medical need and have limited, but positive, risk-benefit data that suggest immediate availability would improve public health. NPRA also wants sponsors to show they can generate more comprehensive data post-approval. 
 
Companies that clear that bar can bring drugs to market on the basis of midphase data. The company will then have an initial conditional approval period of two years, with the option to extend it for two more two-year terms. NPRA will consider further extension beyond six years on a case-by-case basis.
 
Participants in the scheme must submit information to NPRA six months before their approvals end. NPRA is requesting the latest periodic benefit risk evaluation report, updated product information and data from the confirmatory trial. The agency will then assess the current risk-benefit balance before ruling whether to renew the conditional approval.
 
When a company meets the conditions of the conditional approval, NPRA will upgrade it to a full authorization. Equally, if the confirmatory trial fails to demonstrate the efficacy of the product or other evidence shows it lacks safety or effectiveness, NPRA will annul the conditional approval.
 
The guideline become effective at the start of the month.
 
Adoption Notice (Malay)
 
India, Indonesia Plan Drug Regulatory Meeting to Boost Cooperation
 
Drug regulators from India and Indonesia are planning to meet later this year to discuss how they can cooperate. The leaders of the countries committed to the meeting during a recent discussion about areas in which they can work together.
 
The leaders see “considerable cooperation opportunities” in the health and pharmaceutical sector and plan to get relevant people in a room to discuss how to seize them in the second half of the year. The planned meeting will feature drug regulators, health officials and industry representatives, who will create a roadmap for cooperation on R&D, active pharmaceutical ingredients and medical IT.
 
In laying the groundwork for cooperation, India has further expanded its policy of establishing bilateral health agreements with other countries. Over the past year, India has formed drug and medical device ties to Cuba, Iran, Italy and Morocco.
 
Indian Notice
 
Other News:
 
TGA has outlined its efforts to streamline and automate its electronic dossier receipt system. The first phase of the strategy, which is now underway, is focused on automating the validation and uploading of dossiers. Starting soon, the system will tell applicants via email if their submissions are validated, validated but with warnings or not uploaded because of errors. Phase two of the strategy will look at filing dossiers via an electronic gateway. TGA Notice
 
TGA has released a guide for manufacturers of Class I medical devices. The guide covers the factors that dictate whether a device needs a Class I entry in the Australian Register of Therapeutic Goods. TGA Notice