Asia-Pacific Roundup: PMDA puts patients at heart of push for Japan-first approvals
The head of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has outlined plans to get patients and the public more involved in product development. Chief executive Fujiwara Yasuhiro framed the initiative as part of an effort to increase the number of products that come to market in Japan before being authorized overseas.Yasuhiro took over as chief executive of PMDA in April 2019. The following month, PMDA established the Patient Centricity Working Group to further the “patient first” element of Yashuhiro’s “Four Fs” strategy.
While the focus on patients is new, the end goal of more Japan-first approvals is a longstanding PMDA objective. Despite being a major market, Japan suffered from a “drug lag” that meant patients in the country had to wait longer than patients in the US and Europe to access medicines. The Japanese Ministry of Health, Labor and Welfare prioritized addressing the drug lag in 2005.
Yasuhiro shared data on the effectiveness of the actions in a statement issued last week. Of the 355 new drugs approved by PMDA and an overseas regulator from 2008 to 2019, 10% came to market in Japan first. The median drug lag in the 2016 to 2019 period was 2.5 years shorter than from 2008 to 2011. Yasuhiro wants PMDA to build on those successes by involving patients and the public more in the process.
Yasuhiro Statement
TGA plans remote inspections after COVID disrupts GCP pilot program
Australia’s Therapeutic Goods Administration (TGA) is planning to incorporate remote processes into its good clinical practice (GCP) inspection pilot program months after COVID-19 forced the cancellation of three GCP inspections scheduled from April to June.
TGA began the pilot program last year to assess the feasibility of an ongoing domestic GCP inspection initiative the agency thinks could improve its ability to identify and manage risk while enhancing the reputation of clinical trials conducted in Australia. The 12-month pilot program was nearing its end when the COVID-19 pandemic hit Australia. TGA had completed seven inspections by that point but had to cancel a further three planned assessments.
In response, TGA is extending the pilot program and incorporating remote inspection processes. The change could enable TGA to complete the pilot program at a time of restrictions on travel in Australia and demonstrate the feasibility of using remote inspection processes in the future.
TGA shared the update to its GCP inspection pilot program in its good manufacturing practice (GMP) annual report. The report, which covers the year up to the end of June, shows how the pandemic affected the work of the GMP team at TGA.
The number of domestic inspections conducted by TGA fell 16% compared with the prior year. TGA attributed the decline to delays associated with COVID-19 and a six-week period in which it revised its processes to support remote and hybrid inspections. The number of overseas inspections, which have been on pause since March, fell even more, tumbling 32% year on year.
The effect of COVID-19 on TGA shows up elsewhere in the report. TGA received 8% more extension applications than in the 2018-2019 financial year, a change the agency attributed to “the impact of COVID-19 and the suspension of GMP inspections.”
TGA’s 2020-2021 financial year, which began in July, marks the first-time manufacturers have needed to comply with the basic requirements of the current version of the PIC/S Guide to GMP. Companies have been expected to comply since July but TGA has provided a “12 month graduated transition period” to give manufacturers time to adapt their operations. Due to the disruption caused by the pandemic, TGA will assess whether the transition period needs extending before fully enforcing the rules.
The agency published the GMP document alongside a report on recalls in the 2019-2020 financial year. Medicine recalls rose 46%, largely due to the discovery of nitrosamines in ranitidine products.
Annual Report, Recall Report
India tasks National Institute of Biologicals with COVID vaccine testing
The Indian government has asked the National Institute of Biologicals (NIB), Noida, to support the testing of COVID-19 vaccines. Enlisting NIB gives India additional capacity for lot release testing.
India’s Central Drugs Laboratory (CDL), Kasauli, typically handles lot release testing of vaccines. With a COVID-19 vaccination campaign potentially adding significantly to the workload of the Kasauli team, the Indian government has tasked NIB with assisting the CDL.
The selection of NIB for the supporting role reflects its experience in the evaluation of biologicals. The primary statutory function of the Noida site covers the quality of biologicals such as insulin and blood products.
Government Notification
TGA shares guidance on eCTD withdrawals and baseline sequences
TGA has shared new guidance on electronic common technical document (eCTD) withdrawals and baseline sequences as part of the staggered transition to eCTD-only filings.
The withdrawal guidance addresses the processes for notifying TGA of the removal of information from the submission view of the dossier because a product is no longer on the market or a filing has been partly or completely withdrawn. TGA wants companies in those positions to either send a request to cancel the product or contact the application team.
The other document covers the conversion of dossiers from other formats to eCTD. TGA refers to the resubmission of currently valid documents previously provided in an outdated format as a baseline. The guidance details how to create and share an eCTD baseline sequence.
Withdrawal Guidance, Baseline Guidance
Philippine FDA posts guidelines on the regulation of veterinary medicines
The Philippine Food and Drug Administration (FDA) along with the country’s Department of Agriculture has published guidelines on regulating veterinary medicines, including market authorizations and post-market surveillance.
New veterinary regulations are set to take effect in the Philippines in February. The guideline covers the transition period between now and implementation and aims to achieve three goals. Firstly, FDA wants to establish transitory guidelines for the application of veterinary marketing authorizations. Secondly, the agency is trying to ensure “uninterrupted regulatory management services” of veterinary establishments and products. Finally, FDA is aiming to guarantee the continuous supply of essential veterinary medicines.
The document took effect immediately upon its publication.
FDA Guidelines