Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Tweaks New Advertising Code, Supporting Guidance Ahead of Implementation Date
Australia's Therapeutic Goods Administration (TGA) has changed its advertising code and supporting guidance after receiving feedback. The latest version gives the industry until September 2020 to add warnings about eggs, nuts and other allergens to advertisements for registered and listed medicines.
TGA has put the 2018 advertising code and supporting documents through a series of consultations and internal discussions over the past year. Now, with the January implementation date for the new code looming, TGA has made more revisions to the legislation and changed its guidance in response to feedback to a draft released for consultation in August.
The changes give some manufacturers more time to adapt to certain requirements imposed by the new code. Given the overlap between certain health warnings mandated by the code and incoming labeling requirements, TGA has delayed enforcement of some of the advertising requirements to harmonize the timelines. The change gives producers of oral registered and listed medicines until September 2020 to add warnings about eggs, sesame, soya and nuts.
That change is the one formal concession to concerns about the timeline for transitioning to the new code, although TGA will take a light-touch approach to enforcement of some of the rules over the first six months of 2019.
There are overlaps between the areas in which TGA will take a “pragmatic approach” to enforcing the rules and the sections of the code it changed in the latest round of revisions. Notably, TGA used the update to clarify the requirements related to scientific claims and the use of testimonials, which will be subject to enforcement discretion in the months after the code comes into force.
In changing the code, TGA stated that ads that cite scientific or clinical literature must identify the researcher and financial sponsor of the study “where the advertiser knows, or ought reasonably to have known, that information.” The ad must also provide enough information about the study for consumers to be able to access the research.
TGA made more extensive changes to its position on the use of endorsements and testimonials. The changes eliminate the risk that the use of TGA’s new efficacy claimers would result in breaches of the code, and tighten the rules on the use of testimonials. TGA will still permit the use of testimonials in the advertisement of therapeutic goods but only if the company discloses “whether the organization, or employee, has received, or will receive, any valuable consideration for the endorsement.”
The Australian regulatory agency published a summary of the changes to the code alongside version 1.2 of its accompanying advertising guidance document. The latest version, the first published since TGA began a consultation in August, is the result of a significant rewrite and provides more detail on points such what qualifies as “prominently displayed or communicated.”
, Summary of Changes
, TGA Guidance
China Creates Guidance to Fast Track Important Drugs Approved Overseas
China National Drug Agency (CNDA) has released guidance aimed at manufacturers of drugs it wants to make available in the country. The guide builds on the earlier publication of a list of 48 drugs that China is willing to approve on the basis of limited data.
In the summer, CNDA identified clinically important drugs that are available in other markets but are yet to win approval in China. To encourage the manufacturers of these drugs to bring them to China, CNDA offered to issue marketing authorizations on the strength of data showing how they perform in people of different races and ethnicities. The proposal offered a radically reduced path to market but lacked details about exactly what is expected of applicants.
Now, CNDA has shared a document detailing the requirements applicants must meet to bring drugs to market under the truncated pathway. The text addresses some of the key questions raised by the fast-track proposal, such as what data on racial and ethnic differences CNDA wants to see before approving a product.
The section of the guide on racial and ethnic differences refers readers to International Conference on Harmonization (ICH) guidelines. Guided by the ICH documents, prospective applicants should run a consistency analysis to compare the safety and efficacy of their drugs in Chinese or Asian people to European and American populations.
The racial and ethnic analysis is one of five sets of materials requested by CNDA. Applicants will likely already have many of the other materials. CNDA expects applicants to provide documents showing their products are authorized in the United States, European Union or Japan, plus the materials that supported these earlier approvals. Applicants should submit these materials alongside details of their post-marketing risk control plans and a declaration that China will get the same drugs as the West.
Greater clarity about what is expected of applicants could increase use of the pathway. Alexion’s rare disease drug Soliris, one of the 48 drugs eligible for the fast track, won approval in September.
Australia and Canada Extend Mutual Recognition Agreement to APIs
Australia and Canada have expanded their mutual recognition agreement (MRA) to cover active pharmaceutical ingredients (APIs). The change means TGA will accept good manufacturing practice (GMP) certificates of compliance issued by Health Canada in submissions.
Officials in Australia and Canada began working on an MRA covering GMP inspection and certification more than a decade ago. Since then, Canada has changed its regulations on GMPs for APIs to permit the inclusion of drug ingredients in its MRAs with other countries. Canada enacted those changes in 2013.
The revision to the MRA between Australia and Canada takes advantage of the 2013 changes. Under the modified MRA that came into force at the start of this month, applicants can include certificates of compliance from Health Canada in support of GMP clearance submissions to TGA. The change will benefit Australian sponsors that source APIs from Canada.
CNDA Outlines Vision for Drug Traceability System
CNDA has published details of China’s planned drug traceability system. The document discusses what is expected of stakeholders including marketing authorization holders and sets out what work needs to be done to implement the system.
China wants to adopt a traceability system to help keep spurious drugs out of the legal supply chain and ensure only safe, effective products reach patients. Officials expect the companies that make, ship and sell drugs in China to help the effort by setting up drug traceability systems and complying with related responsibilities.
These companies will receive guidance from CNDA. The agency plans to establish a drug information traceability standard system, clarify the basic requirements, share guidelines and provide unified coding requirements and exchange standards. By taking the lead on these topics, CNDA aims to ensure systems and the information they carry are interoperable.
CNDA plans to task its local departments with ensuring appropriate systems are put in place and has warned it will take serious actions against non-compliant companies.
has made the first registration decision under the comparable overseas reports (COR-A) pathway that came into effect at the start of the year. The decision extended the use of Exelixis’ Cabometyx
to adults with poor or intermediate risk of advanced renal cell carcinoma. TGA cleared the extension six months after European regulators approved the drug in the new population. TGA Notice