Prescription medicines registration process in Australia

The registration of prescription medicine in Australia is straightforward, and the TGA evaluates applications for quality, safety, and efficacy. Australia ranks among the largest healthcare markets worldwide as its health system is one of the best in the world and provides quality, safe, and affordable healthcare for its citizens. The value of the Australian pharmaceutical […]

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Market Authorization Holder (MAH) & Designated Market Authorization Holder (DMAH) in Japan

If you plan to register a healthcare product in Japan, previously you would need an In-country caretaker system. After the revision of the Pharmaceuticals and Medical Device (PMC) Act, the Marketing Authorization Holder (MAH) and Designated Marketing Authorization Holder (DMAH).replaces the In-country caretaker system The foreign manufacturer who plans to register their products in Japan […]

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Medical device registration in Myanmar

Medical device registration is a mandatory requirement in Myanmar for companies seeking to market and distribute medical devices. The process involves submitting detailed documentation, including technical specifications, safety data, and evidence of compliance with local regulations. Myanmar offers tremendous business opportunities for U.S. exports of medical devices, equipment, and supplies. Myanmar’s private health sector depends […]

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Nutraceutical, OTC & food supplements regulatory

Myanmar depends on imports for nutraceutical supplements and over-the-counter products. The nutraceutical supplements market in Myanmar is very competitive. Pharmaceutical spending is growing at double-digit growth, and researchers expect it to reach USD 1.1 billion valuations by 2023. Considering the huge opportunities in Myanmar, many companies are showing interest in registering and marketing their products […]

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Digital clinical trials vs traditional trials

The development of digital clinical trials has completely altered every aspect of our lives. One of the sectors with the most room for innovation is the health sector. However, the clinical research sector has been sluggish to accept digital clinical trials and integrate the digital tools that hold the secret to safer, more effective treatments […]

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decentralized & virtual clinical trials

Over the past years, the number of conferences and publications devoted to decentralized and digital clinical trials has skyrocketed in the pharmaceutical research sector. Nearly every clinical research company has joined the conversation, fuelled by the global pandemic. Conferences are there almost weekly to discuss methods and equipment for transferring laboratory-based research to clinical settings. […]

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medical device regulatory in Malaysia

There is a growing demand for medical devices in Malaysia, and overseas manufacturers are showing interest in registering and marketing their medical devices in Malaysia. The Medical Device Authority (MDA), the regulatory body for the medical device industry in Malaysia, projects that the market will grow at a 16.1% annual rate to reach US$1.4 billion. […]

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Malaysia drug approval regulatory

According to a recent analysis by an agency, the Malaysian pharmaceutical market is anticipated to increase from $2.3 billion in 2015 to $4.6 billion by 2022, reflecting a 9.5% CAGR. Seeing this demand many manufacturers are showing interest in registering their drug products in Malaysia. This information was last updated in March 2023. Factors such […]

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patient recruitment strategy in clinical trials

A clinical trial’s outcome depends on several variables, but one of the most important is patient recruitment. Ineffective trial recruitment strategies can cause late-stage trials to be delayed by roughly 11 months, increasing operational costs and extending time to market. Clinical trial recruiting strategies begin with the patient in mind and include a range of […]

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