The process of registering over-the-counter (OTC) medicines in Australia is regulated by the Therapeutic Goods Administration (TGA). The exact process depends on the type of product and the regulatory pathway but typically involves the submission of detailed documentation and scientific data to support the safety, quality, and efficacy of the product. What are OTC (over-the-counter) […]
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We use Standard Operating Procedures (SOPs) – uniformly written instructions with thorough explanations – to document common tasks, procedures, and organizational practices. SOPs in clinical research serve to define the group’s standard practices. They outline the daily research procedures to ensure that we adhere to institutional, state, and federal guidelines while conducting research tasks. We […]
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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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Medical device regulations vary from country to country, and this is not different in Japan. To register your medical device in Japan, you need to look for these top 6 considerations to make your registration process easy. Japan is a global economic powerhouse with one of the largest medical device markets. In terms of US […]
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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 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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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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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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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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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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