Asia-Pacific Roundup: DRAP changes fees for 132 regulatory services, raising rates in multiple areas

The Drug Regulatory Authority of Pakistan (DRAP) has changed the fees for 132 of its services, raising the rate for activities such as granting drug manufacturing licenses.

DRAP published a consolidated notification of its regulatory fees last year. That document set the rates for 177 services. The latest notice partially modifies that and sets DRAP’s rates across areas such as costing and pricing, controlled drugs, pharmacy services, drug licensing, medical devices and pharmaceutical evaluations.

The fee for granting a drug manufacturing license, by way of basic or semi-basic manufacturing, has risen from 45,000 Pakistani rupees ($161) to 56,000 Pakistani rupees. The 24% increase in the fee is illustrative of the amount DRAP has hiked its rates in other areas. The fee for price increases in hardship cases rose 23% and the cost of post-registration variations climbed 20%.

DRAP’s decision to raise its rates 500 days after setting the fees in its consolidated notification comes amid a period of high inflation in Pakistan. The annual inflation rate recently fell to 9.6%, bringing the figure below 10% for the first time in almost three years.

DRAP Notice

India posts notice about data format for marketing code submissions

India’s Department of Pharmaceuticals (DoP) has published a form for disclosing marketing spending in compliance with the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP).

Under the code, pharmaceutical companies must disclose details of their distribution of free samples and spending on activities such as continuing medical education, conferences, workshops, training and seminars. The DoP updated the guidance earlier this year, adding new information on brand reminders, continuing medical education and support for research (RELATED: Asia Pacific Roundup, Regulatory Focus, 18 March 2024).

Companies can provide informational and educational items and free samples as brand reminders but must comply with restrictions on the activities and disclose their spending. The new DoP form covers the information drugmakers need to provide to comply with UCPMP.

Manufacturers can use the form to list all the free samples they distributed, including details of when they were sent, the monetary value of the packs and the number of recipients. Another section covers spending on education, either organized directly by the pharmaceutical company or through third parties such as associations.

Drugmakers must submit the form within two months of the end of each financial year.

DoP Notice

Australia approves new notification forms for clinical trials, additional sites

The Australian government has approved new forms for notifying the Therapeutic Goods Administration (TGA) of new clinical trials and the addition of sites to existing studies.

TGA requires clinical trial sponsors to submit forms via email or post at various points in the study process. The first submission is required before the sponsor starts the trial. Sponsors must also notify TGA within 28 days of starting supply of the therapeutic goods at each site for each new trial, as well as when adding sites to ongoing studies.

Updated forms for notifying TGA of new studies and updates to existing trials are now in place. The new trial form requests information about the investigational medicine, biological or medical device. TGA is asking sponsors to complete a trial site details page for each center involved in a study. The exact information companies need to provide depends on the study and is described in the forms.

TGA updated the forms during a broader review of the clinical trial approval scheme. The administration began assessing the scheme in response to a report on the cell, gene and tissue regulatory framework in Australia. Stakeholders have asked for improved communication about the pathway.

TGA Notice

WHO calls on China to share COVID-19 origins info as pathogen plan advances

The director-general of the World Health Organization (WHO) has called on China to “share all information it has on the origins of COVID-19, so that all hypotheses can be investigated.”

Tedros Adhanom Ghebreyesus made the request in a statement about work to understand the origins of new or re-emerging pathogens. WHO has created a global framework to help countries investigate the origins of pathogens. The global body said the framework is the first “unified, structured approach” to the investigations.

If the framework had been in place when COVID-19 struck, Ghebreyesus said “the quest to understand its origins may have been less contentious and more successful.”

The framework outlines scientific investigations and studies for six technical elements of investigations into pathogens. The elements include early investigations of the first identified cases to find potential sources of exposure, studies to identify animal reservoirs and assessments to determine if a breach in a laboratory may have been associated with the initial infections.

WHO said it is critical that countries share the results of the investigations “in a rapid, complete and transparent manner” to prevent further transmission, “new spillover events” and future pandemics.

WHO Notice

Chinese, Vietnamese regulators meet to discuss drug and device approvals

The deputy commissioner of China's National Medical Products Administration (NMPA) has met with a delegation from Vietnam to discuss areas of cooperation.

At the meeting, the NMPA leader, Zhao Junning, met with Nguyen Duc Hoa, the deputy general director of Vietnam Social Security, to introduce China’s work on the regulation of drugs and medical devices. The topics of discussion included the review and approval of innovative drugs and medical devices, plus the regulation of traditional Chinese medicines, according to NMPA.

The two sides “agreed to further enhance exchanges and cooperation to ensure the quality and safety of medicines and better safeguard the health of the two peoples,” NMPA said.

NMPA Notice

Other news:

Baxter is recalling Tisseel fibrin sealant kits in India after seeing extended dissolution times in stability studies at storage temperatures of 25℃, the Central Drugs Standard Control Organization (CDSCO) said. CDSCO Notice

Asia-Pacific Roundup: DRAP changes fees for 132 regulatory services, raising rates in multiple areas

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