Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Medicines Australia Warns TGA Proposal Would Have a ‘Significant Impact’ on Disease Awareness
Medicines Australia has raised the alarm about planned changes to the Australian therapeutic goods advertising code. The pharma trade group told the Therapeutic Goods Administration (TGA) its core principles for the new code risk disrupting disease awareness campaigns and reducing transparency.
The concerns center on TGA’s intention to prohibit disease awareness campaigns from identifying a “specific therapeutic good or sponsor either expressly or by implication.” Medicines Australia said it is “very concerned” about the implications of delinking disease awareness campaigns from the drug companies that fund them. In the trade group’s view, hiding the identity of the organization behind a campaign is contrary to advertising transparency principles.
Medicines Australia would rather TGA maintained the status quo, as set out in the trade group’s code of conduct. That document specifically states that the sponsor behind a disease awareness initiative must be identified but not be given prominence. Medicines Australia thinks this minimizes the risk of the initiative being associated with a specific company or product, while ensuring consumers have the background they need to evaluate the communication.
Changes to the disease awareness section were one of two recommendations made by Medicines Australia. The other recommendation centers on whether the potential for “inappropriate use, abuse or diversion” is too vague a phrase to guide whether a substance is unsuitable for direct-to-consumer advertising. Medicines Australia fears the lack of clarity will open the door to arguments about whether to change the schedule of a drug.
The proposed changes to the code were more warmly received by firms with consumer healthcare units. Johnson & Johnson and Sanofi voiced broad support for the planned revisions. The companies backed TGA’s plans to make the code less subjective, but were more equivocal and uncertain about some of its other suggestions.
TGA sought feedback on the future of the advertising code last year as a precursor to making changes recommended during the expert review of Australian regulations. The document proposed changes to how advertising requirements are enforced and put forward core objectives for the new code. J&J, Sanofi and almost 30 other organizations responded to the call for feedback.
, J&J Response
, Sanofi Feedback
, All Comments
India’s CDSCO Transfers Senior Staff in ‘Public Interest’ as Reshuffle Continues
The Central Drugs Standard Control Organization (CDSCO) has moved four deputy drug controllers to different offices in the “public interest.” CDSCO took the action days after it parted company with the Drug Controller General of India (DCGI) and transferred 42 more junior staff to new locations.
The latest batch of changes affects four people with the rank of deputy drugs controller, which is below just DCGI and joint drugs controller on CDSCO’s organizational chart. CDSCO is moving A Ramkishan and R Chandrashekhar away from West Zone, Mumbai. Ramkishan is set to land at the Goa subzone. Ramkishan’s new territory is East Zone, Kolkata.
CDSCO has brought in PBN Prasad from its headquarters to take on Chandrashekhar’s work. Rubina Bose, who also previously worked at headquarters, is handling Ramkishan’s former responsibilities. Bose and Prasad will both work out of West Zone, Mumbai.
The statement about the transfer is the latest in a string of releases from CDSCO that discuss major changes to the organization without providing much detail on why it is taking the action. The earlier statement to disclose the transfer of 42 inspectors and technical officers, like the deputy drugs controller release, cited “public interest” as the reason for the move. CDSCO was publicly even less forthcoming about why it ousted Dr. GN Singh from the position of DCGI.
Whatever the thinking, the immediate nature of all the actions means CDSCO has people across its organization who are getting up to speed in new roles at the same time.
TGA Updates Guide to Drug Approval Applications Following Regulatory Changes
TGA has revised its guide to the mandatory requirements for effective approval applications following changes to its regulatory procedures. The latest version of the guide incorporates details of the new priority review pathway and how to make filings based on reports from overseas regulators.
The guide, which was first published in 2010, provides a breakdown of all the information companies need to provide when filing for approval of a medicine in Australia. As comparable overseas regulator (COR) report-based applications and priority review submissions work slightly differently than other types of filing, TGA has updated the breakdown to cover these recently established processes.
Good manufacturing practice (GMP) evidence requirements are affected by both processes. TGA is advising sponsors that take the COR approach to include evidence of GMP compliance or proof that they have applied for GMP clearance and paid the necessary fees for each production plant. TGA is making similar demands on companies that want to receive priority review.
The revised guide features other sections covering the mandatory components of priority review submissions. TGA also expects applicants to include a copy of their priority review determination letters. If the applicant wants to be eligible for a waiver of section 23 submission fees, it must also send a copy of the orphan drug designation.
In adding the section on COR report-based applications, TGA has removed details about category 2 submissions. The category shortened the regulatory review process for drugs that had already been approved in two “acceptable countries.”
CDSCO Posts Q&A Guide to Medical Device Rules
CDSCO has answered questions about the Medical Device Rule, 2017. Indian officials used the 13-page document to explain the effect of the rules on import licenses, notified bodies and manufacturing standards.
Many of the questions addressed in the document are highly specific, despite CDSCO presenting the text as a tool for “creating public awareness” that is unsuited for “legal and professional” use. Topics covered in the document include whether manufacturers that comply with ISO standards also need to follow Bureau of Indian Standards rules and how fees for grouped submissions are handled.
CDSCO released the Q&A alongside a notice about the finalization of the fees notified bodies will charge for auditing manufacturing sites. Notified bodies will charge about $300 “per man-day for audit of manufacturing site including product assessment.” That fee excludes travel costs, which are expected to top out at around $180 per auditor per visit.
, Fee Notice
The China Food and Drug Administration
(CFDA) has released guiding principles for the review of certain technologies. The documents cover the polymerase chain reaction-based detection of human epidermal growth factor and assessments of infection with Helicobacter pylori
. CFDA also addresses anti-human globulin and nucleic acid tests of enterovirus infection in the texts. CFDA Notice
’s Ministry of Health, Labour and Welfare
has approved a drug for suppressing replication of the flu virus. A single dose of the drug, Shionogi
’s Xofluza, is designed to stop the virus in one day. That means the treatment should act faster than existing antiviral Tamiflu. Cutting the number of doses should also eliminate the compliance issues that arise when prescribing Tamiflu. Press Release
health ministry has set up a subcommittee to reexamine the 344 fixed-dose combinations regulators tried to ban. The action follows a ruling by the Supreme Court. Pharmabiz