Asia-Pacific Roundup: Japan’s PMDA shares principles for evaluation of COVID-19 vaccines

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published principles for evaluating COVID-19 vaccines. The principles echo guidelines published in other parts of the world, for example by recommending that studies are designed to show vaccines prevent COVID-19.
 
PMDA, like its peers, is against the use of surrogate measures given the lack of evidence linking them to the key endpoint of COVID-19 prevention. Clinical trials to assess the preventive effect of vaccines against COVID-19 will be needed to access the Japanese market. PMDA lists confirmed SARS-CoV-2 infection, arterial oxygen saturation, requirement of oxygen therapy and death as other possible key endpoints.
 
The guidelines leave the door open to the use of other efficacy measures in the future. If studies link an immunogenic marker to the ability of a vaccine to prevent COVID-19, PMDA may permit vaccines to come to market on the basis of preclinical evidence of efficacy and immunogenicity data from a Japanese clinical trial.
 
In terms of safety, PMDA wants sponsors to collect all adverse events for at least 28 days after the administration of the vaccine. Longer safety monitoring periods may be needed for some vaccines. The US Food and Drug Administration is asking sponsors to gather two months of median follow-up on subjects before seeking emergency use authorization for a COVID-19 vaccine.
 
A separate section of the PMDA guidelines mandates long-term follow-up. PMDA wants sponsors to track subjects for at least one year. Again, PMDA said vaccines with certain characteristics may need a longer follow-up period. PMDA expects sponsors to collect information on antibody titers, adverse events and incidence of COVID-19 during the follow-up period.
 
PMDA promoted the principles the week after unveiling a free scientific advice service for COVID-19 vaccine developers. The service will enable organizations to discuss clinical trial protocols and other aspects of their development programs with PMDA.
 
PMDA Notice, Evaluation Principles, More
 
TGA seeks to balance innovator, generic interests in new transparency measure
 
Australia’s Therapeutic Goods Administration (TGA) has established new transparency measures intended to balance the tension between the interests of branded and off-patent drugmakers that became evident during a recent consultation.
 
In April, TGA shared feedback on its plan to publish details of medicines it accepts for evaluation. The branded drug industry voiced broad support for the plan, with the caveat that the same rules should apply to novel and generic medicines. Generic drugmakers, in contrast, argued the timing of their filings is commercially sensitive information that should not be published.
 
TGA ran a targeted consultation earlier this year to find a path forward. With none of the proposals put forward by TGA receiving broad support, the agency has come up with a compromise designed to address the concerns of off-patent companies and provide “a better balance between innovator and generic interests.”
 
Under the new proposal, the first company to seek approval for a particular generic or biosimilar will need to notify the patent holder when TGA accepts its application for evaluation. The reporting requirement will only apply to the first generic or biosimilar copy of a branded medicine.
 
“This change is intended to provide greater opportunity for early negotiation and resolution of disputes on potential patent infringements and invalidity before inclusion of generic and biosimilar medicines on the Pharmaceutical Benefits Scheme. It should reduce the need for protracted and costly litigation,” TGA wrote.
 
TGA put forward the proposal alongside less contentious plans to share a description of the major innovator applications that it is reviewing. Starting in January, TGA will share details such as the name, active ingredient and proposed indication of medicines it is evaluating, plus the identity of the sponsor.
 
TGA Notice, Consultation Responses
 
India’s DGFT lifts restrictions on the export of N95 masks
 
India’s Directorate General of Foreign Trade (DGFT) has lifted all restrictions on the export of N95 masks. The new policy, which also applies to FFP2 masks and equivalent, comes around one month after DGFT established a quota for exports of the respirators.
 
DGFT banned the export of N95 face masks from India early in the pandemic. The agency kept the ban in place even as it progressively lifted the restrictions it placed on the exports of other pieces of personal protective equipment and pharmaceutical products, likely reflecting the importance of N95 masks to the response to COVID-19 and the persistence in countries including the US.
 
India outlined plans to resume contributing to the global supply of N95 masks in late August, when DGFT unveiled plans to allow certain companies to ship 5 million masks a month. Now, DGFT has lifted all restrictions on N95 masks.
 
The change means all types of masks are freely exportable from India. Most pandemic products are now freely exportable from India, with diagnostic kits and laboratory reagents being a rare exception. Diagnostic kits and laboratory reagents are subject to an export quota. 
 
DGFT Notice
 
Pakistan’s DRAP publishes draft guidelines on handling complaints
 
The Drug Regulatory Authority of Pakistan (DRAP) has released draft guidelines on the handling of complaints made by the public. DRAP created the guidelines to help the public and its own staff.
 
In the guidelines, DRAP sets out general objectives for its system, stating that its staff should properly investigate complaints, issue timely and appropriate responses to the people who make them, and if required take corrective actions in response to the information. Complaints made without substantial evidence, particularly those against an employee, may be dismissed to save time and resources.
 
DRAP also describes the responsibilities of DRAP’s vigilance cell, which is tasked with working with other divisions to integrate complaint information, and the steps in the complaint handling process. Once a complaint is lodged, the vigilance cell will set the priority level for the submission and share it with the relevant person for investigation. The vigilance cell will assess the findings and share them with the complainant.
 
The guidelines are open for comment for 15 days.
 
Draft Guidelines
 
TGA posts guidance on changing sponsor details in product information, labels
 
TGA has released guidance explaining how sponsors can change their details on prescription drug product information (PI) and labels.
 
Sponsors must immediately update the PI when their information changes, for example due to the transfer of the ownership of a product. TGA gives sponsors 12 months to change the information on the label. Sponsors can supply medicines featuring the old information for up to 12 months while waiting for TGA approval.
 
TGA is asking organizations that need to change the sponsor details on the PI to use its TGA Business Services online platform to complete a self-assessable request (SAR). The agency aims to approve SARs covering changes to the PI and label within 45 working days. TGA will approve label changes filed as a separate notification within 48 hours.
 
TGA Guidance
 
Other News:
 
TGA has issued fines of AU$278,640 ($201,000) on a single day. The daily total is more than one-fifth of all the non-COVID-19 fines issued by TGA in its 2019-2020 fiscal year. PharmaCare Laboratories received the largest of the fines over the alleged omission of milk products from the ingredient warning on batches of fish oil and certain webpages. TGA Notice, More