Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Seeks Feedback on Use of Boxed Warnings to Highlight Safety Issues
The Therapeutic Goods Administration (TGA) of Australia is seeking feedback on guidance about the boxed warnings used to highlight serious safety issues. TGA is running the consultation to understand whether people support the guidance and gauge how it will affect them.
Today, more than 30 products sold in Australia carry boxed warnings to alert readers of the product information (PI) to specific safety issues with major public health implications. The boxes are found at the start of the PI, separate from the section that lists adverse events linked to the product. Sponsors can propose to add boxed warnings to products, or TGA can request their inclusion in the PI.
Similar warnings are applied to products sold around the world, but there is a lack of harmonization. As such, TGA has drafted guidance to ensure sponsors understand their obligations in Australia, while also explaining the rationale for boxed warnings to prescribers.
The draft guidance permits TGA to request boxed warnings on the strength of data from independent sources and to apply them to all products within a class of medicines. A product may require a boxed warning even if researchers are yet to fully show a causal link between it and the adverse event. TGA wants to know whether people support these proposals and if they will create any difficulties.
TGA could propose warnings in response to a range of events. The non-exhaustive list presented by TGA includes the identification of an adverse event that tips the risk-balance profile, either in all patients or a subpopulation, and evidence that a drug is far less effective in some people than others.
The guidance also discusses the content and format of boxed warnings. TGA thinks boxed warnings should provide a succinct statement that directs the prescriber to a more detailed discussion of the safety risk elsewhere in the PI. In TGA’s view, boxed warnings will rarely need to discuss data sources. TGA wants to know if companies and prescribers support that proposal.
To ensure the warning is seen and understood, TGA is recommending the use of language patients will easily understand, a font at least as big as that iused in the rest of the PI and the inclusion of the word “warning” in bold capitals.
TGA is accepting feedback on the draft until the end of the month.
China Offers Regulatory Fast Track to 48 Drugs Approved Overseas
China’s Center for Drug Evaluation (CDE) is offering the developers of 48 drugs a truncated path to market to address unmet medical needs. CDE is willing to approve the drugs on the strength of data showing they perform the same in people of different races and ethnicities.
All the drugs are already available in the United States, the European Union or Japan, and some of them have been on the market for more than a decade. Despite this history of use in these markets, the medicines are yet to make their way to China. For most of that time, an arduous regulatory process and uncertain commercial prospects have deterred companies from seeking approval.
CDE is seeking to dispel those perceptions and ensure Chinese patients have access to effective drugs available in other markets. To meet those goals, CDE is offering the manufacturers of 48 medicines the chance to win approval on the strength of a limited dataset.
With all these products already available in major markets, CDE is confident in their general safety and efficacy. CDE is less clear on how the drugs perform in Chinese patients, and as such wants to see a racial sensitivity analysis. If the companies can provide that analysis, a post-marketing plan and some paperwork, the China National Drug Administration (CNDA) will approve their products.
The initiative could make it easier for companies including Merck, Novartis and Pfizer to bring their drugs to China. A significant minority of the drugs treat cancers. Others, such as Spark Therapeutics’ gene therapy Luxturna, target rare diseases. The one constant is the drugs address unmet needs in China.
Experts at international law firm Hogan Lovells called the reduced regulatory requirements “yet another encouraging development in China for international pharmaceutical companies.” However, some uncertainties make the full significance of the program unclear.
“It is unclear at this point whether CNDA will consider additional new drugs to be added to the list. It is also unclear what data CNDA requires to demonstrate no racial or ethnic differences that would affect the efficacy,” the experts said.
CDE is accepting feedback on the proposals until 18 August.
(Chinese), Hogan Lovells
Guided by Early Feedback, TGA Revises Advertising Code Guidance, Starts Consultation
TGA has revised guidance about complying with the 2018 Therapeutic Goods Advertising Code after receiving feedback on an early draft. The revised text provides far more detail on key concepts, such as the general rules about what advertisements must contain.
In the early draft, which was still in development at the time of the consultation, TGA allocated one page to the general rules. The same section of the revised draft covers five pages. In enlarging the section, TGA has clarified that health warnings must be prominently displayed or communicated, provide more details about how the code applies to medical devices and expanded on the exemption for short-form advertisements. The short-form exemption applies to written ads of fewer than 300 characters that are not accompanied by multimedia.
TGA has provided more details about other aspects of online advertising, too. The earlier guidance stated internet advertising must contain more information than other forms of promotion, as it could encourage people to buy a product online, depriving them of the chance to read the physical label. This thinking shapes the latest draft, which goes into more depth about its implications.
TGA is accepting feedback on the draft until 4 October. The plan is to publish the final guidance in November.
India Clarifies GMP Requirements for Medical Devices in Update to Q&A
The Central Drugs Standard Control Organization (CDSCO) has clarified aspects of India’s Medical Device Rules, 2017 in an update to a question and answer document. CDSCO used the update to address uncertainties about the application of good manufacturing practices (GMPs) to devices.
The rules refer to quality management systems but make no mention of GMPs, leading to questions about what is expected of medical device manufacturers. CDSCO has addressed these questions by stating “there is no requirement of GMP certificates for medical devices and [in-vitro diagnostics
That clarification raises a follow-up question about how companies can meet requests for certificates from overseas regulators. CDSCO covers this point in its Q&A, stating that licensing authorities will issue GMP certificates in response to requests from importing countries.
has revealed a jump in the number of reported adverse events related to medical devices. Last year, TGA received 5,370 medical device adverse event reports, 40% more than in 2016. An uptick in the number of reports submitted by sponsors — a group that accounted for 85% of all reports — was responsible for the trend. TGA Report
has issued guidance on the evaluation of the performance of IVDs. The guidance lists the types of IVD that may require performance evaluation reports, as well as the names of facilities that will carry out the tests on different categories of products. CDSCO Guidance