Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
J&J, Medtronic Lead Pushback Against TGA Device Priority Review Proposal
Johnson & Johnson and Medtronic have criticized the Therapeutic Goods Administration (TGA) of Australia's proposed priority review pathway for medical devices. Both companies found fault with multiple aspects of the proposal and said they are unlikely to apply for medical devices to have priority review status under the current model.
Participants in the consultation are broadly in favor of TGA adopting a priority review pathway. However, the comments provided by J&J, Medtronic and others create significant doubts about whether the pathway will cut the time it takes for patients in Australia to access new safe, effective medical devices. J&J sees this as a fundamental failing of the proposal.
"We have concerns that the current proposal does not actually allow for accelerated assessment but rather 'front of queue' processing," J&J wrote in its feedback. "We are also concerned that only those technologies having substantial clinical data would be considered for priority review. This would seem to exclude promising new technologies that may have limited clinical data at the earliest stages of development, but would benefit from expedited review."
Similarly, Medtronic said TGA's expectation of "clinical evidence" will limit the pathway to devices that are already supported by enough data to meet Australian guidance on clinical expectations.
J&J compared TGA's proposal unfavorably to comparable pathways in place elsewhere, notably the United States. The device maker cited the Food and Drug Administration's (FDA) expedited access pathway as an example of how regulators can cut the time and cost of development through the use of priority reviews, data development plans and other mechanisms.
The companies are also concerned they will be detrimentally affected by the pathway even if they opt against using it for their own devices. This concern is centered on TGA's ability to keep up with the processing of standard medical device applications while giving special attention to priority review filings. J&J cited the clinical assessor constraints that delayed level two application audits to support its argument that the pathway could stretch TGA too thin.
TGA is changing the draft in response to some of the comments. The agency has summarized the changes resulting from the public consultation in a table that covers the designation process, criteria for priority review designation and the processing of applications.
The regulator is set to implement the pathway at the start of next year.
J&J Submission, Medtronic Submission, All Submissions
India Creates Draft SOPs for Handling Substandard Drug Samples
India has created draft standard operating practices (SOPs) for handling not of standard quality (NSQ) samples. The SOPs provide analysts with a step-by-step guide for what to do when tests find samples that are outside the range of specified limits and as such are classed as NSQ.
Officials want to implement a multi-step process for handling NSQ samples. The first step is for the analyst who generated the out-of-specification result to report their finding to an authorized person. This person will review the test data and process to ensure the result is real and not the result of an error, such as the failure to properly weigh the sample, perform the dilution or prepare the reagents and solutions.
The authorized person then orders another analyst to test the sample. If the sample fails the test again and the results are within 2% of the first readout, the lab declares the drug to be NSQ. The higher of the two test results is reported.
Samples that comply with the standards during the second test or deliver results different from those generated in the first analysis undergo further testing. If results from the third test match those generated in the first, out-of-specification analysis, the sample is declared to be NSQ. If the third and second test results match, the sample is declared to be of standard quality.
Either way, the authorized person must then investigate and review the analysis and procedure. The authorized person then publishes a report detailing their findings. The report must list the batch number, dates and certain reference numbers.
Publication of the draft SOPs follows a Drugs Consultative Committee recommendation regarding the need for a standardized process for handling NSQ samples.
The draft is open for comment until 12 July.
DCGI Notice, Draft SOPs
TGA Creates Q&As for Manufacturers of Dose Administration Aids, Compounded Medicines
TGA has created question and answer advice documents for manufacturers of dose administration aids (DAAs) and compounded medicines. The Q&As clarify how TGA's therapeutic goods legislation applies to pharmacists who pack drugs in DAAs or compound medicines.
Publication of the Q&A documents comes one month after TGA released a good manufacturing practice guide for producers of compounded medicinal products. The compounded medicine Q&A builds on that earlier document by answering 12 questions pharmacists working at community pharmacies may have about the guide and regulatory aspects of providing drugs to patients.
Some of the questions are very general. Basic questions addressed by the Q&A include whether a community pharmacy is classed as a public institution under the therapeutic goods regulations. The answer to that question is no.
Other questions are more specific. One is how pharmacists can supply patients who request parenteral drugs with shelf lives of more than 24 hours. TGA's response notes that the Pharmacy Board has delayed the implementation of guidance on parenteral medicines with shelf lives of 24 hours or more to give it time to consult with stakeholders. TGA will update its position once the pharmacy board has made its final ruling.
The DAA Q&A is shorter. DAAs are well sealed, tamper-evident devices that organize medicines by their dosing schedules. Pharmacists who put drugs into DAAs are effectively packing medicines and as such would typically need to hold a manufacturing license. However, as TGA notes in the Q&A, the legislation exempts pharmacists from the requirement provided certain conditions are met.
Other questions addressed in the Q&A include whether pharmacists can engage a third party to pack their DAAs, or whether they themselves can pack DAAs for another pharmacy. In both cases, the answer is yes, provided such activity is permitted by state and territory legislation.
DCGI Raises Sensitivity Acceptance Criteria for Tests of Hepatitis B, HIV
The Drug Controller General of India (DCGI) has increased the sensitivity acceptance criteria for tests used to diagnose hepatitis B and HIV infections. Tests must now achieve 100% sensitivity, one percentage point more than was acceptable under the old criteria.
DCGI Dr. GN Singh notified the industry of the change following a review by the National Institute of Biologicals' (NIB) technical committee. The committee considered the importance of accurately diagnosing the diseases in making its decision. Quality control testing and lot release of diagnostic tests must now comply with new, more stringent criteria.
NIB's committee opted against changing other criteria. The minimum sensitivity for rapid kit tests for the hepatitis C virus remains at 99%. NIB's committee also kept the minimum specificity level for rapid tests against all three types of virus at 98%.
Indian regulators set the earlier, less stringent sensitivity test criteria in 2003.
DCGI Order, Old Criteria