Combination products are a distinct class of medical products created by physically or chemically combining two (02) or more regulated components (drugs, quasi-drugs, and medical devices) and producing them as a single unit.
- February 22, 2023 Pharmaceuticals, Regulatory Affairs
- February 21, 2023 Food and Food Supplements, Regulatory Affairs
As per the regulation on Non-carbonated Water-based Beverages (Non-Alcoholic) released by the FSSAI on July 26, 2021, all FBOs were required to comply with the amended provisions by February 01, 2022. According to the amendment, “non-carbonated water-based beverages” (non-alcoholic) refer to drinks made with water that meet the requirements for packaged drinking water or mineral water but without adding carbon dioxide.
- February 17, 2023 Medical Devices
The primary distinction between a Unique Device Identifier (UDI) and a barcode in medical device labeling is that the UDI is a standardized identifying number assigned to each medical device, whereas a barcode is a graphic that can be scanned and read by a barcode…
- February 17, 2023 Publishing & Submissions, Regulatory Software & Services
China’s pharmaceutical industry has seen substantial growth since its entry into the World Trade Organization (WTO). As of 2021, China holds a 12% share of the global pharmaceutical market, making it the second largest contributor. According to Xinhua News Agency, the Chinese pharmaceuticals market generated 708.75 billion yuan in 2021, while the Chinese domestic medicinal companies amassed 502 billion USD in profit.
- February 9, 2023 Pharmaceuticals, Regulatory Affairs
New Chemical Entity (NCE) minus 1 filing, also known as a paragraph IV filing, is a type of application submitted to the U.S. Food and Drug Administration (FDA) for a new drug that is a slight variation of an existing drug. The minus 1 in the type of submission refers to the fact that the NCE is one small change away from an existing drug that has already been approved by the FDA and marketed under its surveillance.
- February 8, 2023 Medical and Scientific Communication, Regulatory Medical Writing
Direct-to-Consumer (DTC) drug advertising has become a favorite topic of discussion in recent years. These advertisements, which are aimed at consumers rather than healthcare professionals, have been credited with increasing patient awareness and demand for certain drugs. However, they have also been criticized for potentially leading to overdiagnosis and overtreatment.
- February 7, 2023 Pharmaceuticals, Regulatory Affairs
South Korea, the 11th largest economy in the world, is a hub for talent and skilled labor. The Korean healthcare infrastructure and strategy took the world by surprise in the early COVID-19 times. They curated an ideal model for testing and isolating early suspects for containing the viral outbreak.
- February 6, 2023 Publishing & Submissions, Regulatory Software & Services, Regulatory Consulting
The process of submitting Regulatory documentation to Health Authorities can be complex and time-consuming. Many organizations partner with a vendor that offers a submission tool to ease this process. With so many options in the market, it can be difficult to know who the right strategic partner is for your submission requirements.
- February 6, 2023 Pharmaceuticals, Regulatory Affairs, Regulatory Labeling
Summary of Product Characteristics (SmPC) is a medical monograph created and updated by pharmaceutical companies based on product research and knowledge. It offers much more than a structured list of vital information on each drug, such as fixed dosage and potential side effects.
- February 6, 2023 Regulatory Affairs, Publishing & Submissions, Regulatory Software & Services
eCTD, a standardized submissions format, was established based on the Regulatory Product Submissions (RPS) standard (HL7 standard) with advice from the ICH. The current eCTD version 3.2.2 will soon be replaced by version 4.0. With various modifications designed to simplify the process for sponsors and Regulatory authorities, eCTD V4.0 has officially been issued.