Asia-Pacific Roundup: India and the Netherlands agree to cooperate on medical product regulation

The Indian government has signed a Memorandum of Intent (MoI) with the Netherlands to support cooperation on medical product regulation and to enhance the quality of medical products and health care services for both countries.

Last week, an Indian delegation led by Shri Bhagwant Khuba, the Union Minister of State for Chemicals and Fertilizers, visited the Netherlands to attend the second World Local Production Forum (WLPF) meeting. The World Health Organization (WHO) created the WLPF to improve access to medicines and other health technologies by facilitating strategies and partnerships on sustainable local production.

As part of the visit, Khuba met with Ernst Kuipers, Minister of Health, Welfare and Sports of the Kingdom of Netherlands, and signed the MoI. The Indian government’s statement about the MoI lacks details beyond the top-line focus on cooperating on medical product regulation and enhancing the quality of medical products. The Dutch government has yet to publish a statement on the agreement.

Khuba also used the trip to the Netherlands to visit the European Medicines Agency (EMA). During the visit, the Indian minister met Carla van Rooijen, Director of the Pharmaceuticals and Medical Technology Division at EMA, “and had a fruitful discussion with her about regulations in the pharmaceutical and medical technology industries.”

The signing of the MoI and meeting with EMA come at a time when India is working to transform its regulatory environment to support the development, manufacture and use of innovative medicines. Increasing alignment with international regulations is central to the government’s plan for creating an environment that is more conducive for innovative drug developers.

Press Release

Japan’s PMDA calls for support to help patients claim compensation for adverse drug reactions

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is asking health care professionals to help ensure patients who are harmed by medicines can access the Relief System for Adverse Drug Reactions.

The Relief System, which was established in 1980, is designed to provide compensation to patients who suffer adverse health effects, such as disorders or disabilities, caused by adverse reactions to drugs despite proper use. From its establishment through the end of Fiscal Year 2022, a total of 29,014 cases were granted relief via the system, which is funded through contributions from marketing authorization holders.

However, most people remain unaware of the system. A 2022 survey of the general public found just 11.2% of people “were aware” of the Relief System and 24.9% had “heard about” the system. The figures have caused concerns at PMDA.

“It is inferred that some people may not file an application for compensation for adverse health effects associated with ADRs that they have suffered because they are unaware of the Relief System,” PMDA wrote in its November information publication.

PMDA is looking to health care professionals to help ensure more patients file for compensation. Awareness of the system is higher among health care professionals, with 83.8% of surveyed providers having some level of knowledge of the compensation mechanism.

The Japanese drug regulator added a field for information on the Relief System to the form that health care professionals use to report adverse drug reactions in 2014. PMDA is now asking health care professionals to consider introducing the Relief System to the patient when reporting adverse events.

Increasing awareness of the system could counteract the trend of decreasing relief claims. From 2019 to 2022, the number of applications for relief fell by 23% to 1,230. The annual number of applications for relief has fallen each year since 2019.

PMDA Notice

Australia, New Zealand, Pakistan and the Philippines promote #MedSafetyWeek

Drug regulatory agencies across the Asia-Pacific region have been promoting their plans for #MedSafetyWeek, outlining their work to promote the reporting of adverse events by consumers and health professionals.

#MedSafetyWeek, which ran for a week starting 6 November, is a global event intended to support pharmacovigilance activities. This year, the initiative involved 100 organizations from 88 countries, up from 32 medicine regulators when it began in 2017. The Therapeutic Goods Administration’s (TGA) Elspeth Kay discussed Australia’s goals for the event.

“People became more alert to the issue during the COVID-19 pandemic and learned how to report. This helped us greatly in tracking the safety profile of vaccines. We ask everyone to have a discussion with their friends and family to raise awareness. I’m confident the non-English translations of the campaign materials will help the message spread more widely,” Kay, TGA’s Pharmacovigilance Branch Head, said in a statement.

The Uppsala Monitoring Centre in Sweden coordinates the event, which has a different focus each year. This year, the theme was “Who can report?” and focused on how patients, doctors, pharmacists and other health professionals can contribute to pharmacovigilance. Regulators in Australia, New Zealand, Pakistan and the Philippines were among the authorities to take part in the social media event this year.

TGA Notice, Medsafe Notice, DRAP Notice, FDA Notice

Malaysia’s MDA to stop accepting hard copy advertisement applications next month

Malaysia’s Medical Device Authority (MDA) will stop accepting hard copy advertisement applications on 1 December.

Communications that “promote the use or supply of anything related to medical devices” are covered by the Evidence Act 1950 in Malaysia. Companies need to comply with the Code of Advertisement. In some cases, compliance is controlled through self-regulation but other communications require approval from MDA.

Currently, MDA accepts hard copies of materials that companies want to clear for use. However, the authority will stop accepting hard copies at the start of next month. From then on, all completed advertisement applications must be sent to MDA via email. Applicants must pay processing fees via bank draft or BayarNow. MDA will not accept cash or online payments.

MDA Notice

TGA warns Australian mobile and WiFi outage may affect users of glucose monitors

Australia’s TGA warned users of glucose monitoring devices and systems that their technologies may have been affected by a mobile and WiFi outage that hit an Australian telecommunications network last week.

On 8 November, an outage at the second largest telecommunications company, Optus, left nearly half of Australia’s population without Internet or phone access. The outage lasted for more than 13 hours and affected multiple hospitals, which have become more reliant on telehealth and electronic messaging systems in recent years.

TGA said users of glucose monitoring devices and systems may have been impacted by the Optus mobile and WiFi outage. The regulator asked patients “to be vigilant about possible interruptions to ongoing glucose monitoring” and report concerns to a health care professional. TGA added that other devices that use network connections or Bluetooth, such as defibrillators, may also have been affected by the outage.

TGA Notice

Other News:

Singapore’s Health Sciences Authority (HSA) has warned the public against using products containing modafinil or armodafinil unless they are prescribed by a doctor or used under close medical supervision. The warning followed the hospitalization of three people with serious adverse reactions. HSA Notice

Asia-Pacific Roundup: India and the Netherlands agree to cooperate on medical product regulation

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