Asia-Pacific Roundup: Japan’s PMDA starts offering consultation services from new US office
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has begun offering consultation services from its recently opened office in Washington, DC.PMDA opened the office, its first in the US, in November as part of a push to support drug developers that want to launch medicines in Japan. Last week, the agency updated its webpage about the office to include information on the general consultation services it is offering. The services are intended to help companies understand Japan’s approach to application reviews and post-marketing safety measures.
Companies engaged in the development of drugs, medical devices or regenerative medicine products in the US can request a general consultation if they are interested in seeking approval in Japan. PMDA has created a form companies can use to express their interest in arranging a consultation.
Meetings typically take place at PMDA’s US office, but the regulator said it is open to joining Microsoft Teams calls hosted by applicants. PMDA schedules up to 30 minutes for each consultation and, because of the size of its meeting room, limits attendance to two to three people. The agency is providing consultations for free but is only giving oral feedback and there are restrictions on what it can discuss.
“PMDA Washington DC Office will not provide any advices specifically related to business, strategic or legal matters on your products,” the agency said. “However, upon request, PMDA’s review team in the Tokyo Headquarters, through separate consultation arrangements, will provide guidance and advice on specific development plans for individual products.”
The agency cited the sufficiency of non-clinical study data and appropriateness of clinical study protocols as examples of topics that the Tokyo team can discuss. PMDA’s head office has offered consultations for years but the talks take place in Japanese, with applicants advised to appoint a local marketing authorization holder or, for pre-consultation meetings, work through an interpreter.
PMDA Notice
China tallies up 48 first-in-class new drug approvals in 2024, hitting a 5-year high
China approved 48 first-in-class innovative drugs in 2024. The figure exceeded the 40 approvals in 2023 and 21 authorizations in 2022 and represented the highest level of activity in five years.
The National Medical Products Administration (NMPA) published the figures. NMPA said the approvals spanned almost 20 therapeutic areas, including oncology, neurological disorders, endocrine diseases and anti-infective medicines.
Some of the products benefited from initiatives NMPA has established to accelerate access to new drugs. The regulator said 17 of the medicines received approval through its priority review pathway. The 48 authorizations included 11 conditional approvals and 13 medicines that were covered by breakthrough therapy programs. The first-in-class approvals were part of a broader use of the priority review pathway.
“In 2024, the administration completed 110 drug approval applications covering 74 different categories under the priority review pathway, marking a year-on-year increase of 29%,” Yuan Lijia, an official at NMPA’s Center for Drug Evaluation, told China Central Television.
Priority review reduces the process from 200 to 130 working days. NMPA has handled almost 500 drug approval applications under its priority review pathway since China updated its drug registration and administrative rules in 2020. More than 40% of the priority reviews have covered cancer treatments.
NMPA also reported approvals of 55 rare disease medicines and 106 pediatric drugs. A further 35 drugs received expanded pediatric indications. NMPA said the pediatric approvals and label expansions could help address the shortage of treatment options in children.
NMPA Notice, More
Philippine FDA mandates manual submissions of contraceptive product filings
The Philippine Food and Drug Administration (FDA) has begun requiring the manual submission of certain applications for contraceptive products.
Under the new rules, FDA said applications for the Certificate of Listing of Identical Drug Product and Renewal for Reproductive Health products shall be filed manually. FDA directed affected companies to forms that they can download and submit to its Food and Drug Action Center, as well as to a circular they should follow.
The agency said the submission changes comply with legislation on responsible parenthood and reproductive health and implementing rules and regulations for the act. The law was created in 2012 to give free, universal to modern contraceptives, but opponents mounted legal challenges in the years after the legislation was passed.
The law requires the agency to ensure reproductive health drugs and devices sold in the Philippines are “scientific, safe and non-abortifacient,” meaning they do not cause abortions. FDA is responsible for giving certifications and registrations to products that meet the regulatory standards and to revoke the authorizations of drugs and devices that are proven detrimental to public health after coming to market.
Early this year, FDA held a consultation into the certification of contraceptive products that contain levonorgestrel and ethinyl estradiol, hormones that are used in birth control pills. The agency requested evidence on products from three manufacturers that contain the same active ingredients.
FDA Notice
India’s Department of Pharmaceuticals trains staff in push to build capacity
India’s Department of Pharmaceuticals (DoP) has organized a training program as part of a push to build capacity and enhance the skills of civil servants.
Officials framed the program as a response to the need for Indian civil servants to “undertake constant learning and knowledge development to stay relevant in the face of new challenges and emerging best practices elsewhere.” Richa Pandey, director at DoP, led the training sessions with the support of India’s capacity building unit.
Objectives of the sessions included “developing leadership skills” and “adopting a solution-oriented approach.” DoP said the competition of the program “marks a significant step in capacity building, equipping officials with essential skills and a progressive mindset to drive efficient, citizen-focused governance.”
Press Release
Philippine FDA warns of disrupted access amid push to make portal more reliable
The Philippine FDA has warned that its ePortal will be offline at some times as the agency works towards “providing a more efficient and reliable system.”
Writing last week, the agency said it was “currently undergoing system maintenance and upgrades to enhance our online services and facilitate the migration of ePortal processes to eServices.” FDA said the actions “may cause some inconvenience” but justified the disruption on the grounds that the improvements “are essential to ensure a more efficient and seamless transaction for all users.”
The agency said that, starting 22 March, the ePortal will only be accessible 24 hours a day from Monday to Friday. The planned uptime for the portal excludes “weekends, official public holidays, declared holidays and work suspensions,” FDA said.
FDA Notice
Other News:
The Philippine FDA has updated the list of drugs that are exempt from value-added tax. The agency said the expansion of the list is intended to reduce healthcare costs and support access to quality care. Certain treatments of cancer, diabetes, hypertension, tuberculosis, mental illness and high cholesterol are exempt from the tax. The standard rate in the Philippines is 12%. FDA Notice (Filipino)
The Philippine FDA has scheduled a virtual public consultation to inform the development of a planned circular on the qualification criteria for grouping medical devices in product registration. The meeting will take place online on 16 April. FDA has invited representatives of the medical device industry to the event. FDA Notice
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