Asia-Pacific Roundup: PMDA posts points to consider for psoriatic arthritis clinical trials

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has shared key considerations for sponsors of clinical trials for psoriatic arthritis.

Published as part of PMDA’s early consideration series, the document features advice informed by local psoriatic arthritis clinical practice guidelines, recent changes in Japan’s drug development landscape, and accumulated scientific knowledge. Japanese psoriatic arthritis guidelines target disease remission, but PMDA said treatment is often guided by “the more attainable goals of minimal or low disease activity.”

Between 8% and 13% of psoriasis patients in Japan have psoriatic arthritis, according to the PMDA. The figure led the agency to predict that it would be challenging to run a confirmatory trial solely in Japan with a sufficient sample size to evaluate efficacy and safety.

Since there are no significant differences in the pathology, diagnosis, and treatment of psoriatic arthritis in Japan and overseas, the PMDA has recommended that sponsors consider conducting multi-regional clinical trials at an early stage. The agency has advised sponsors that detect potential barriers to Japan’s participation in global trials, such as ethnic differences in pharmacokinetics, to consult with its staff.

A discussion of considerations for confirmatory trials forms the centerpiece of the document. PMDA said that, while sponsors may consider using “an existing medicinal product with a similar clinical positioning” as an active comparator, a placebo control is generally expected to be employed.

The agency divides the patient population into two groups: those who have not tried biologics and those who have experienced an insufficient response to biologics. Sponsors targeting both biologic-experienced and biologics-naive patients can run separate confirmatory trials in each group. Alternatively, sponsors can consider a combined study if exploratory trials find no significant differences in responses between the groups.

PMDA has recommended that sponsors use the American College of Rheumatology (ACR) response rate as the primary endpoint of their trials. The agency said that while the European Medicines Agency (EMA) supports the use of Minimal Disease Activity (MDA) criteria as a primary endpoint, academic, industry, and regulatory stakeholders in Japan have yet to reach a consensus on the validity of the measure. The lack of consensus led PMDA to conclude that MDA criteria cannot be “actively recommended” as a primary endpoint.

PMDA Document

CDSCO makes Indian licenses a mandatory medtech procurement requirement

The Central Drugs Standard Control Organization (CDSCO) has told procurement agencies the medical devices they buy must have an Indian license.

CDSCO published the notice after learning that procurement agencies are insisting that medical devices have a European CE mark or US Food and Drug Administration authorization. Buyers have been making demands despite medical devices being regulated in India under the Medical Devices Rules, 2017. The regulation requires devices to have a valid domestic license to be sold in India.

State regulators issue manufacturing licenses for Class A and B devices, the two lower-risk categories in India. Manufacturing licenses for higher-risk Class C and D devices are handled centrally, with CDSCO responsible for issuing the paperwork.

Depending on the risk classification, devices purchased by procurement agencies such as hospitals must have a state or CDSCO license, the regulatory agency said. Procurement agencies can require devices to have other certifications, but they must be in addition to the mandatory Indian license.

CDSCO Notice

Indian authorities take steps to encourage adverse drug reaction reporting

CDSCO and the Indian Pharmacopoeia Commission (IPC) have unveiled separate initiatives to support the reporting of adverse drug reactions (ADRs).

At a June meeting of the Pharmacovigilance Programme of India (PvPI), officials ruled that all state and union licensing authorities should prominently display a QR code linking to the IPC’s Adverse Drug Reactions Monitoring System (ADRMS) at every retail and wholesale pharmacy in the country. The CDSCO shared details of the ruling last week, adding that each pharmacy should clearly display the PvPI’s toll-free phone number along with the QR code.

CDSCO stated that displaying the QR code and PvPI phone number will help the public and healthcare professionals report adverse events more easily via the ADRMS.

Separately, the IPC signed a memorandum of understanding with the Jharkhand State Pharmacy Council (JSPC). The agreement positions the IPC and JSPC to support ADR reporting and pharmacovigilance and materiovigilance practice adherence by working with registered pharmacists in the state. Goals include encouraging wider participation in reporting and reinforcing drug safety surveillance mechanisms.

CDSCO Notice, IPC Statement

Hong Kong plans pilot to slash review times for proprietary Chinese medicines

Hong Kong’s Department of Health (DH) is preparing to start a pilot program to cut registration times for proprietary Chinese medicines.

Starting on 1 January, DH will pilot processes designed for two new tiers of products. DH will evaluate “innovative drugs” within 120 working days, compared to the current average processing time of more than 250 working days. The new pathway is open to products classed as “innovative traditional Chinese medicines” on the mainland.

The second new tier covers “designated priority products,” which DH will evaluate within 150 working days. Applicants can designate up to two products as priorities each year. After evaluating an innovative or priority drug, DH will send the product to the Chinese Medicines Committee for approval.

The new mechanism will “enable the industry to select products to test the market response, establish product positioning, and use Hong Kong as a springboard to tap into global markets,” according to Edmund Fong, Assistant Director of Health, Chinese Medicine.

DH is planning to run the pilot for two years. The department has written to licensed wholesalers and manufacturers about the new mechanism and will hold monthly online seminars to provide additional information.

Press Release, FAQ

TGA leader speaks out to reassure Australians about vaccine safety and efficacy

The head of the Therapeutic Goods Administration (TGA) has co-authored a statement reaffirming that vaccines sold in Australia are safe, effective, and supported by strong evidence.

TGA head Anthony Lawler published the statement with Australia’s chief medical officer Michael Kidd. The health leaders twice refuted the link between vaccines and autism in the joint statement and made the case that Australian systems are equipped to detect safety signals.

“In Australia, every vaccine undergoes comprehensive scientific and clinical assessment by the TGA before approval,” according to the statement. “Once in use, vaccines are monitored through robust post-market surveillance, including reporting of adverse events, analysis of clinical and community data, active safety monitoring programs, and continuous review of evidence from international regulators.”

TGA Notice

Other news

India’s National Pharmaceutical Pricing Authority (NPPA) has extended the existing ceiling prices on knee implants until 15 November 2026. NPPA deferred a decision on the orthopedic device ceiling price by two months in September while it reviewed feedback from manufacturers and industry groups. India first implemented a cap on knee implant prices in 2017. NPPA Notice

Asia-Pacific Roundup: PMDA posts points to consider for psoriatic arthritis clinical trials

Related topics

Recommended content

Welcome to the new RAPS Digital Experience