Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
CFDA Posts Draft Guidance on Postapproval Manufacturing Changes
China Food and Drug Administration (CFDA) is seeking feedback on its guidance on postapproval manufacturing revisions. The draft texts propose three tiers of changes to production processes and detail the regulatory steps companies need to take in each circumstance.
Echoing draft guidance posted by the US Food and Drug Administration (FDA) earlier this year, CFDA is proposing to class postapproval changes as "major," "moderate" or "minor." The classification of the change is determined by its possible impact on drug safety, efficacy and quality and dictates the level of regulatory scrutiny it will face.
CFDA, like its counterpart in the US, wants companies to receive its blessing before making major changes. This precaution reflects the risk such changes will alter the attributes of the drug.
The agency is proposing a more relaxed approach to moderate and minor changes. To make a moderate change, a company must make a submission to CFDA. Unless CFDA denies or challenges the change within a certain amount of time, the applicant can go ahead and make the revision. Companies can make minor changes without first contacting CFDA.
In some circumstances, CFDA expects manufacturers to submit three batches made after the change for testing by one of its regional outposts.
When moving to a new production site, CFDA expects manufacturers to use Quality-by-Design principles to understand their products and manage the relocation. This entails considering the possible effects of moving to a new site on critical quality attributes.
CFDA set out its thinking on the subjects in three documents. The agency is accepting feedback on the drafts until 13 November.
CFDA Notice (Chinese)
Sun Pharma Claims Drugs That Failed CDSCO Quality Tests Were Fakes
The Central Drugs Standard Control Organization (CDSCO) has included two pantoprazole brands sold by Sun Pharma on a list of drugs that failed quality tests. However, Sun claims the drugs tested were counterfeit and has branded their inclusion on the list as "misleading."
Sun’s Pantocid and Pantocid DSR, standard and sustained-release formulations of acid reflux drug pantoprazole, are two of the 22 products on CDSCO’s latest list of medicines that have recently failed tests. The list cites "dissolution and assay" as the reason for the failures.
Talking to The Economic Times, a spokesperson for Sun said additional testing and a joint audit by the Drug Control Department and Sikkim FDA have shown the products were counterfeits. However, the drug alert released by CDSCO makes no mention of these details.
Sun has reportedly asked CDSCO to pull the products from the list of drugs that failed the quality tests. The firm made the request on the grounds the drugs’ presence on the list is "misleading."
Data generated by the Indian government suggest Sun was unlucky to have counterfeit versions of two of its drugs end up in the tests. The government’s large, multi-year testing program found 0.02% of the sampled drugs were spurious. Other estimates have suggested counterfeits are more prevalent than that in India.
CDSCO Alert, The Economic Times
China Approves Locally Developed Recombinant Ebola Virus Vaccine
CFDA has approved a locally developed recombinant Ebola virus vaccine. The agency is presenting the fast development and approval of the vaccine as testament to its emerging willingness and ability to shorten the route to market.
Private drugmaker Tianjin CanSino Biotechnology and the Bioengineering Institute of the Chinese Academy of Military Medical Sciences filed to start testing the vaccine in humans in January 2015. In response, CFDA set up a dedicated working group to handle on-site verification, technical review and the inspection of samples.
In the months since the co-developers submitted clinical data to CFDA, the agency has liaised with the applicants and experts to move the vaccine toward a regulatory decision more quickly and smoothly than is typical.
The upshot for the applicants and public health officials involved in managing Ebola is that a freeze-dried vaccine is available. CFDA thinks the freeze-dried nature of the vaccine makes it better suited than rival liquid formulations for use in parts of Africa that lack cold-chain transport and storage.
For CFDA, the the development and approval process provides it with experience of fast-tracking programs at a time when it is trying to encourage innovation and truncate timelines.
CFDA Notice (Chinese), Caixin
TGA Publishes eCTD Specification Ahead of 6-Month Transition Period
Australia’s Therapeutic Goods Administration (TGA) has released its incoming electronic common technical document (eCTD) specifications. Applicants can start using the new specification from January, although TGA will continue to accept the existing version until the end of June.
The six-month transition period allows TGA to adopt eCTD changes to support its priority review and provisional approval as soon as possible, without forcing all applicants to switch to the latest specification so soon.
TGA’s release of eCTD version 3.1 is made up of multiple files covering the Australian regional backbone schema for module 1, an accompanying style sheet, codes for the regulatory activity lead and other topics. The agency has also included a sample eCTD submission.
The headline changes to the specification relate to the regulatory changes TGA is making in response to the expert panel review of its processes and pathways. TGA’s priority review pathway is already in place. The provisional pathway designation is due to go live early next year.
CDSCO Appoints New Leaders of Drug, Device and Clinical Trial Units
CDSCO has reshuffled the leadership at its headquarters and zonal offices. The headline changes in the reorganization are the appointments of new leaders dedicated to drugs, medical devices and clinical trials.
The current joint drug controllers, India (JDCIs) have taken two of the leadership posts. Dr Eswara Reddy is now responsible for areas including new drugs, vaccines, recombinant DNA-based drugs and import registrations. Fellow JDCI Dr. VG Somani has taken on a brief covering medical devices, in vitro diagnostics, fixed-dose combinations, subsequent new drugs and stem cells.
CDSCO has filled the third post by promoting Dr. K Bangarurajan to the rank of JDCI. Bangarurajan previously served as deputy drugs contoller for CDSCO’s West Zone. Now, Bangarurajan will oversee all matters relating to clinical trials and cross-border interactions.
The appointments establish a group of three people, one rank below the Drug Controller General of India in the CDSCO hierarchy, who are focused on specific types of products and tasks under the agency’s jurisdiction.
CDSCO has also made changes lower down its organizational ladder, but is yet to share full details of these appointments publically.
CFDA has selected 10 medical device registration applications for scrutiny. The spot checks will entail on-site assessments of the authenticity of clinical trial data included in the submissions. A magnetic resonance imaging system, intraocular lens and drug-eluting balloon catheter are among the devices selected for assessment. The checks form part of CFDA’s attempts to stop devices coming to market on the strength of fraudulent or substandard data. CFDA Notice (Chinese)
TGA is setting up a Therapeutic Goods Evaluation Panel. The panel will replace the Therapeutic Goods Assessment and Advisory Services Panel. TGA has put out a request for tender to support the establishment of the new panel, which will provide medical and scientific evaluation services. The new panel is due to start operating in July. TGA Notice