Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Ignores Calls to Extend Transition Period for Incoming Advertising Code
Australia’s Therapeutic Goods Administration (TGA) has ignored calls to extend the transition period for its revised advertising code. Organizations including Johnson & Johnson asked TGA to give them up to two years to bring their products into compliance with the new rules.
There is considerable overlap between the requirements of the existing 2015 code and its planned 2018 successor, meaning existing advertisements will largely comply with the new set of rules. However, J&J and others think few advertisements will be fully compliant. That will force organizations to tweak ads to bring them in line with the new code. J&J used its feedback on the draft code to articulate the scale of this task to TGA.
“Making this happen is not a quick or simple task. There are also significant financial implications for changing all advertising material, as well as resource challenges,” J&J wrote in feedback to TGA. “It will be the same resources that are involved in changing over advertising material, that are also responsible for implementing [incoming Australian medicine labeling requirements] TGO 92.”
In light of these factors, J&J asked TGA to give the industry a two-year transition period, not the six-month switchover the agency originally proposed. TGA referred to the requests for an extended transition period in its summary of the incoming changes but is sticking with its original plan.
The new code will come into effect at the start of next year. Ads pre-approved before the end of the year will be judged against the 2015 code until their expiration. Applications decided from the start of 2019 onward will be subject to the new code, but TGA will take a more lenient approach early on. Over the first six months of 2019, TGA will work with companies to correct some ads, particularly those that fall foul of new rules on the use of mandatory statements.
While TGA retained its original transition timeline, it was more amenable to other changes proposed by the industry. After reviewing the 44 submissions to TGA’s consultation on the draft code, officials made tens of changes to the document. The changes affect most parts of the document.
TGA is working on further changes to the text. The changes, which are expected to be in place next month, address ongoing areas of uncertainty about the application of the code. Points TGA plans to address include the definitions of “health warning” and “prominently displayed or communicated,” plus the sections on required statements that the agency thinks could be a cause of noncompliance in the months after the new rules take effect.
The agency does not expect the latest changes to inconvenience advertisers who have already begun preparing promotions based on the version of the code that passed into law earlier this year.
, Industry Feedback
, TGA Summary
TGA Posts Safety Advisory About General Anesthetic Agents
TGA has released a safety advisory about inhaled and injected general anesthetic agents and sedative medicines. The advisory details TGA’s plans to update product labels following an investigation into the effects of the medicines on the development of the brains of young children.
Australian officials looked into the effects of the drugs after learning of tests performed in animals. These studies linked the medicines to cell death and other effects on developing brains that could lead to deficits in learning and behavioral progress. There is some evidence the magnitude of effect on brain development correlates with exposure time to the medicines.
The Advisory Committee on Medicines (ACM) deemed the preclinical evidence of the effect on brain development to be strong. However, ACM was more equivocal about the implications of the findings for humans.
ACM found clinical trials related to the question to be inconclusive. Some studies did link surgeries requiring anesthetics to negative developmental outcomes, but ACM felt it was unclear whether the drugs were responsible. Other factors such as the underlying illness or complications arising from the procedure could be the cause of the reported developmental outcomes.
With ACM also finding evidence that briefly exposing healthy children to anesthesia is unlikely to cause long-term harm, TGA is proposing measured changes to the labeling of anesthetic agents and sedatives. The agency is working with sponsors to implement these changes, which will discuss the findings and limitations of the preclinical and clinical evidence gathered to date.
In parallel, TGA is advising healthcare professionals to consider talking to pregnant women and the parents of young children about the potential effects of anesthetics and sedatives on developing brains before performing surgical procedures in these groups. TGA said healthcare professionals should balance these risks against the harms that could arise if surgery is delayed or avoided.
Pakistan Shares GMP Audit Checklist to Inform Quality Inspections
The Drug Regulatory Authority of Pakistan (DRAP) has published a checklist for good manufacturing practice (GMP) inspections. DRAP’s checklist runs through all the questions that must be answered to ascertain whether a manufacturing facility complies with quality requirements.
Much of the document will be familiar to people well-versed in GMP inspection priorities in other markets. The form covers basic information about the manufacturer, its inspection history and the focus of the latest assessment before detailing the specific points that the audit will evaluate. These points are broken up into sections on quality assurance, premises, personnel and other topics.
For each question, the form has space to provide a yes or no answer, plus a section for remarks about the finding. In this way, the form facilitates assessments of whether a company has a quality policy, restricts access to its facility and otherwise complies with GMPs.
Publication of the checklist comes around one year after Pakistan revised its standard operating practices for the issuance of GMP certificates. The revisions provided applicants with the right to appeal and modified the timelines for reinspection.
China Outlines Forms of Applicant-Regulator Communication in new Annex
The China National Drug Administration (CNDA) has published a document about the different ways applicants can communicate with regulators. CNDA’s text covers the various types of meeting open to sponsors across the clinical trial process, as well as exchanges focused on post-marketing risks.
After outlining the range of meetings applicants can hold with Chinese regulators, CNDA sets out how companies can request and prepare for the chance to discuss their programs. CNDA released the guide to regulatory communications, which is replacing a 2016 document, alongside an application form, a meeting minutes template and another document about meeting materials.
The release of the documents comes at a time when CNDA is trying to make its regulatory processes more amenable to drug developers and, by extension, increase access to novel medicines in China.
has provided an update on two drug shortages. The agency expects Arrow Pharmaceuticals
’ struggles to supply enough Anginine
to drag on into the new year. TGA has cleared Pfizer
and HL Pharma
to source products from the United States and United Kingdom to mitigate the supply constraints. In a separate development, Sanofi
told TGA it expects the Clomid
shortage to continue for another year. The drug has been in short supply since 2014. Arrow Notice
, Sanofi Notice