Asia-Pacific Roundup: India revises pharmacovigilance guidance for vaccines

India’s Central Drugs Standard Control Organization (CDSCO) recently issued revised guidance for industry on pharmacovigilance requirements for human vaccines. The guidance was updated to align with the New Drugs and Clinical Trials Rules, 2019.

“The main focus of this guideline is to identify the risks, formulate the risk profile of a vaccine and its administration programme, design an appropriate pharmacovigilance plan to mitigate such risks and to explore the missing critical information which did not emerge during premarket Phase 1/2/3 trials and therefore safety profile had not been established,” CDSCO wrote in the guidance.

The guidance focuses on pharmacovigilance activities during the post-licensure period. Specifically, the guidance states that the marketing authorization holder will develop a comprehensive pharmacovigilance plan. Although methods may vary based on the product, indication and population being treated, key methods include individual case safety reports, passive surveillance/spontaneous reports, stimulated reporting and active surveillance. However, CDSCO cautioned that each method has limitations. For example, data included in spontaneous reports are often incomplete and the reporting rate may depend on the time since launch or media attention, according to the guidance.

The guidance also describes the documents that must be created and updated as part of the Pharmacovigilance System Master File (PSMF). The PSMF must cover pharmacovigilance personnel and their responsibilities, including information on training. The Master File should also include information on contract research organizations, a description and flow diagram of the complete pharmacovigilance process, sources of safety data, standard operating procedures, computerized systems and databases, a description of the quality management system, and metrics of the pharmacovigilance system performance.

Guidance

DRAP introduces centralized case management for therapeutic goods

The Drug Regulatory Authority of Pakistan (DRAP) has debuted a centralized case management system for therapeutic goods that aims to improve industry efficiency and ease of use.

The new system allows applicants to track regulatory submissions and add requested information during the approval process. The so-called eAPP module debuted on 29 May and provides a secure portal for therapeutic goods manufacturers, importers and exporters, as well as clinical trial sites and contract research organizations.

Submissions made through the module will be forwarded to the director of the appropriate DRAP divisions. The agency recommends that applicants use the online system to follow up on applications rather than visiting DRAP offices in person.

“We are hopeful that implementation of this new system will significantly improve the visibility of application processing and streamline regulatory operations,” DRAP wrote.

DRAP Announcement

TGA updates warning on sexual dysfunction with antidepressants

Australia’s Therapeutic Goods Administration issued a safety update for selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs), announcing that Product Information (PI) for all drugs in this class had been revised to include the risk of persistent sexual dysfunction after stopping the drugs.

While the risk of sexual dysfunction with SSRIs and SNRIs was already part of the PI for these products, only three products carried warnings about persistent sexual dysfunction. Updated warnings have since been added for six additional drugs.

The TGA has received 89 reports of sexual dysfunction with either an SSRI or SNRI to April 2024 in its Adverse Event Management System database. Of those reports, four referred to persistent sexual dysfunction post-treatment, ranging from 12 months to 3.5 years. Since persistent sexual dysfunction is likely to be underreported, TGA encourages health professors to report if they are suspicious of an association with SSRIs or SNRIs.

Safety Update

Medical device harmonization training kicks off in China

The Global Harmonization Working Party (GHWP) Academy held its first training session on medical device harmonization at the South China University of Technology in Guangzhou on 27 May. More than 300 attendees, including representatives from 12 regulatory authorities and five international organizations, attended the event. The training was organized by the GHWP Academy, part of GHWP, and the Guangdong Institute of Advanced Biomaterials and Medical Devices.

“The training aims to further enhance the regulatory capacity of the Global Harmonization Working Party (GHWP) member countries and regions and to further promote the innovative medical devices to ultimately benefit all patients worldwide,” according to a statement from GHWP.

Opening remarks were delivered by Xu Jinghe, GHWP Chair and Deputy Commissioner of the National Medical Products Administration of China (NMPA). He highlighted the increasing demand for regulatory convergence as global trade expands.

During the five-day training, attendees discussed global medical device regulatory harmonization, the device industry innovation outlook, the global premarket regulatory framework for medical devices, the practices of innovative Chinese medical device manufacturers, and sharing and exchange among innovative medical device enterprises.

Press Release

Hong Kong, China sign cooperation agreement to modernize medicines

The Government of the Hong Kong Special Administrative Region (HKSAR) has signed a cooperation agreement with China’s National Institutes for Food and Drug Control, part of NMPA.

The agreement, which aims to modernize medicines, includes technical exchanges related to developing standards for Chinese Materia Medica (CMM), establishing collaborative mechanisms for Chinese medicine specimens, and creating talent and academic exchanges. Along with the cooperation agreement, the NMPA presented HKSAR with 21 CMM specimens, including a set of cordyceps showing different growth stages and specimens from assorted production regions in Mainland China. The specimens are expected to contribute to the identification of CMM.

This agreement is the latest step in ongoing collaboration between the HKSAR Department of Health and NMPA related to Chinese medicines testing, reference standard research and the Chinese Medicines Herbarium, including previous gifts of CMM and technical advice on the establishment of the Government Chinese Medicines Testing Institute.

Press Release

Asia-Pacific Roundup: India revises pharmacovigilance guidance for vaccines

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