Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Provides Guidance as Black Triangle Adverse Event Scheme Goes Live
Australia’s Therapeutic Goods Administration (TGA) has posted guidance on its black triangle adverse event reporting scheme. The scheme came into force at the start of the year, leading TGA to share a guide that addresses some of the uncertainties expressed by industry in advance of the go-live day.
Adoption of the scheme means newly and provisionally approved medicines, with the exception of biosimilars and flu vaccines, and drugs approved in new populations must feature an inverted black triangle on their product and consumer medicine information (PI/CMI). The symbol must be accompanied by text that explains that the product is subject to additional monitoring, and as such adverse event reports from healthcare professionals and patients are particularly valuable.
That basic outline of the scheme and the January 2018 start date was first proposed back in 2016. In the intervening months, TGA has sought feedback on its plans and published materials to clarify the uncertainties identified during the consultation. The text published this week continues that process.
TGA has used the publication of the text to resolve outstanding queries made by organizations such as Medicines Australia during the consultation. This includes a discussion of what happens when a drug comes to the end of the five-year period in which it must display the black triangle.
“At the end of the five-year period, or agreed period for provisionally registered products, a product’s inclusion in the scheme will automatically lapse. You will be required to submit updated versions of your PI and CMI, with the black triangle symbol and accompanying text removed,” TGA wrote. The agency will provide more information on the submission process in the future.
Publications over the past few months should have given manufacturers the information they need to implement the scheme. What is less clear — and will only become so with time — is whether patients and healthcare professionals are aware of the scheme and understand why it is in place and what it means for them. The need to initiate a communication campaign to convey these messages was among the points raised by respondents to last year’s call for comments.
Specific concerns expressed by respondents included the need to clarify that a product’s inclusion in the black triangle scheme does not indicate that it is unsafe.
China Posts Guidance on Medical Device Data From Foreign Clinical Trials
The China Food and Drug Administration (CFDA) has adopted technical guidance on the use of data generated in overseas medical device clinical trials. CFDA is open to accepting clinical data generated overseas to reduce the duplication of studies and cut the time it takes for medical devices to come to market in China.
Drug, diagnostic and device companies have traditionally had to run clinical trials in China to satisfy regulators about the safety and efficacy of their products. However, the government signaled a shift in thinking in October when it included a move to accept data generated overseas in a list of reforms designed to make China more amenable to medical innovation.
Discussions of the October reforms largely focused on the effect of the liberalization of the rules on drug companies, but it is now clear China includes data on medical devices in its new way of thinking.
To facilitate the use of clinical data from foreign trial sites in Chinese regulatory filings, CFDA has published guidance on the topic. The text covers the basic standards clinical trials must meet to yield data acceptable to CFDA — such as adherence to the Declaration of Helsinki — and more specific points related to matters including the testing of devices in different ethnic and cultural groups.
These matters are no longer immovable barriers to the use of overseas data, but CFDA wants medical device manufacturers to consider the implications of where their data is generated. This means looking at the genetics of the patient population, as drug developers must do, and taking actions more specific to devices. These include considering cultural factors that may affect how a device is used.
If differences in the patient populations or healthcare environments in China and the country where the data were generated could lead to clinically significant differences in outcomes, CFDA wants the company to try to reduce or eliminate the differences. This might be impossible, in which case the company may need to generate data in Chinese patients to confirm the overseas results.
CFDA Statement (Chinese)
CDSCO to Stop Accepting Offline Clinical Trial, Marketing Applications
India is to stop accepting offline applications related to recombinant DNA derived drugs at the start of next month. Beyond that, companies must use the online Sugam portal to apply to run clinical trials, market or import insulins, monoclonal antibodies and other recombinant DNA drugs.
The Central Drugs Standard Control Organization (CDSCO) of India began accepting some applications through Sugam late in 2015. After two years in which CDSCO gradually expanded use of the portal to cover more types of regulatory filing but left the offline option open, the agency has recently started making companies file online.
CDSCO began 2018 by eliminating the offline option for filings for human vaccine clinical trials, marketing authorizations, registration certificates and import licenses. The agency is now eliminating the offline option in the recombinant DNA sector. The action affects the same list of regulatory processes as the earlier human vaccine policy.
The agency’s willingness to drop offline applications suggests it has fixed some of the teething problems that dogged Sugam during its phased rollout. Those issues delayed the introduction and uptake of some modules of the online portal and prompted CDSCO to pressure its IT partner to make the technology flawless.
Australia Switches to New Recall Procedure Following Familiarization Period
TGA has switched to its new uniform recall procedure for therapeutic goods. The new way of working came into force on Monday following a three-month period in which manufacturers had a chance to familiarize themselves with the revised approach.
The length of the familiarization period reflects the extent to which TGA changed the recall process. TGA tweaked the first version of its recall process multiple times after it introduced it in 2004, but the changes ushered in this week are more significant than those earlier revisions.
Changes made by TGA for version 2.0 of the text include the introduction of new types of recall action, product defect corrections and alerts, plus the adoption of a new type of non-recall action: quarantine.
TGA views the changes as a way to bring its recall process in line with best practices.
CFDA has released a list of publications that can carry advertisements for prescription medicines. The move clears companies to advertise their products in journals covering neurology, neurorehabilitation, orthopedics, nutrition and other fields. CFDA included five journals on its list of those cleared to carry adverts. CFDA Notice (Chinese)
TGA has updated its prescription medicine registration form. The form is intended for use by companies seeking to register new drugs or to alter approvals of existing products, for example by adding targeted indications or changing the formulation. The revised form is suitable for use by applicants that want to use reports from overseas regulators to support their filings. TGA Notice