Asia-Pacific Roundup: Japan’s PMDA revises position on electronic study data for new drug applications

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has updated its position on submitting electronic study data for new drug applications to reflect experience gained in recent years.

PMDA published a notification and associated question-and-answer document on submitting electronic study data for new drug applications two years ago. The updated documents retain most of the content of those earlier texts. PMDA said the changes it has made are based on its experience of the submission of electronic study data.

PMDA has updated a section on data standards, clarifying that submitting electronic study data in a format other than the Clinical Data Interchange Standards Consortium (CDISC) standards is sufficient for most Phase I and clinical pharmacology studies that started before 1 April 2020. The exception is Phase I studies of cancer drugs.

PMDA also updated three responses in the associated Q&A. One updates reflects the changes to the notification. PMDA also has updated a table to explain that formats other than the CDISC’s SDTM and ADaM are allowed for Phase I and clinical pharmacology studies that began before 1 April 2020.

In another question, PMDA has deleted “in the ADaM format” from advice on what to do if “submission of the analysis datasets of efficacy and safety in the ADaM format is difficult.”

Another updated response relates to a question about “products for which the evaluation of study results is practically carried out before new drug applications.” PMDA’s response now states “electronic study data submission should be carried out during the period from the date of submission of the consultation application to the date which the consultation materials are scheduled to be submitted.” PMDA previously set out a five-week timeframe for submissions.

PMDA Notice

New Zealand’s Medsafe updates standards for contraceptive devices after consultation

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is pushing ahead with plans to update the standards for contraceptive devices after a consultation found support for the changes.

Medsafe proposed moving to new ISO standards for copper-bearing contraceptive intrauterine devices as well as for three other types of contraceptive devices in 2020. The agency proposed the changes to bring New Zealand in line with updates that had happened internationally since it last revised its standards in 2014. Medsafe held a two-month consultation in 2020.

Last week, Medsafe published the results of the consultation and outlined the next steps. The agency received 11 submissions, including one each from a sponsor, manufacturer, importer and industry body. Around 10% of respondents voiced objections to plans to move to new standards for natural latex rubber condoms, female condoms and copper-bearing contraceptive intrauterine devices.

The highest rate of objection (27%) related to plans to move to a new standard for reusable natural and silicone rubber contraceptive diaphragms. Medsafe said the reasons for the objections “were lack of knowledge of the change, the product was no longer available, and for one respondent the proposed standard still did not permit sale in New Zealand of a product developed by the company.”

Medsafe found that the sole supplier of one of the product types covered by the consultation had not provided feedback, leading it to contact the company directly. The company said it had no objection to the proposed changes for the product it supplies.

Based on the feedback, Medsafe plans to adopt the revised standards. The standards will take effect on the day they are published in a gazette notice. After that, all products imported or introduced to the New Zealand market will need to comply with the new standards.

Medsafe Notice

Malaysia’s NPRA seeks feedback on planned changes to bioequivalence inspections

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has shared a draft update to its guidance on bioequivalence inspections. The agency is seeking feedback on the draft until 6 May.

NPRA published the first edition of the guideline in 2014, almost three years after the regulator, which was then called the National Pharmaceutical Control Bureau, began conducting inspections to enforce a policy that took effect in 2012. The draft second version of the guideline retains the structure of the first edition but features new subsections and rewritten content.

The agency is planning to add a subsection on study specific inspections, in which it explains that it will determine if a bioequivalence assessment is needed based on bioequivalence desktop evaluation (BEDE) submissions.

“Applicants may submit the application for study specific inspection if the BEDE evaluation indicates that an inspection is required,” NPRA wrote. “Study specific inspection applications will only be accepted with a BEDE decision requiring an inspection or the BE study does not fulfill the minimum requirements to submit a BEDE application.” The inspection will cover all non-exempt studies.

Another new subsection describes how NPRA determines the duration of inspections. The number of days depends on factors such as the number of studies and sites being inspected, as well as the number of inspectors performing the assessment. NPRA has provided examples, explaining that a study specific inspection of one clinical site and bioanalytical site in the same facility will take two inspectors five days.

The agency, which provided estimated durations of a variety of inspections, added that it will contact the applicant to finalize the number of days and inspectors when “the configuration of clinical and bioanalytical sites is different or inspections to additional third-party service providers are required.” The cost of the assessment will “reflect the arrangements required to cover the scope of inspection.”

NPRA Notice

Medsafe warns of possible risk of new-onset eczema with calcium channel blockers

Medsafe has shared details of a possible link between new-onset eczema and calcium channel blockers to encourage further reporting on the potential safety concern.

The class of medicines includes AstraZeneca’s Plendil ER, Bayer’s Nimotop and Viatris’ Isoptin. Patients take the class of drugs to treat high blood pressure, angina and irregular heartbeats. The products’ data sheets list signs and symptoms associated with eczema, such as itching and redness, but not the condition itself.

New Zealand’s Centre for Adverse Reactions Monitoring (CARM) had received six reports of eczema where the suspect medicine was a calcium channel blocker as of 18 March. Five of the reports named felodipine, the active ingredient in products including Plendil ER. The sixth report related to diltiazem, which several companies sell in New Zealand under brands such as Cardizem CD and Dilzem.

Medsafe highlighted the potential safety concern after CARM received a report about a 69-year-old man who was diagnosed with adult-onset eczema associated with calcium channel blocker use several years after starting to take felodipine to treat high blood pressure. Medsafe has put the drug class on its Medicines Monitoring scheme to encourage reporting of new-onset eczema cases.

Medsafe Notice

Other news

Australia’s Therapeutic Goods Administration (TGA) has shared an update on a shortage of the antibiotic Bicillin L-A that began in 2023. Pfizer Australia told TGA the shortage will continue until the middle of 2024. The update led TGA to approve the importation and supply of a second overseas-registered product until the end of September. TGA Notice

Asia-Pacific Roundup: Japan’s PMDA revises position on electronic study data for new drug applications

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