In a way to support and encourage pharma companies to work upon developing drugs or medical devices in rare disease, several country regulatory agencies are coming up with various benefits such as faster approvals, fee concessions and financial benefits etc. These countries include the US, Europe, Japan, Australia, South Korea and most recently, India. Incentives […]

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Financial benefits, faster approvals and less stringent clinical data requirements are some important benefits that regulatory agencies across the world offer as incentives for development of orphan drugs for rare diseases. These countries include the US, Europe, Japan, Australia, South Korea, Brazil and most recently, India. These incentives have been so supportive and convincingly helpful […]

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Most of the processes to approve drugs in the EU are similar to those of the FDA, such as getting pre-authorization for use of the drug in clinical trials. After clinical trials, FDA drug approvals follow a centralized path, whereas European approval can occur through 4 different paths, depending on the nature of the drug, timeline, […]

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Learning about global regulatory requirements and understanding the pathway for approval can help clinical development teams take their global strategy in the right direction. Sharing expertise from regulatory experts for those who need it. (This article was originally published on LinkedIn). It’s no news that we are now living in an era with tremendous surge of […]

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Nutraceuticals or Health supplements are gaining importance and becoming a part of the consumer’s daily diet. With the increase in life expectancy and subsequent increase in lifestyle-related diseases, nutraceutical or health supplements have emerged as a necessity for consumers, especially in a developed market and Europe is not an exception to it! Novel food represents […]

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Cost and time for clinical development constitute more than 70% of total development of any drug! Small – mid scale biopharma are known for their innovative approaches, agility and faster developments. However, clinical development has always been one step too important, yet too hard for them. There are ways to overcome these challenges and optimize […]

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Do you know that Australian complementary medicines are viewed as the consumer protection benchmark internationally? Numerous complementary medicines are recognised as a premium brand in Australia and internationally. The obvious reason being – Australia’s complementary medicines industry is proudly backed by a regulatory regime that is regarded as one of the strictest in the world! […]

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Nutraceutical, dietary or food supplement products, also known as “Health Supplements” have been in use since many years to maintain, enhance and improve the healthy function of human body. These may contains one or more, or a combination of vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other bioactive substances. Each country differs in […]

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Australian regulators do not distinguish between medicines and complementary medicines when it comes to safety, efficacy and quality of the product, including the imported products! Read the first part of this series – Regulatory Approval for Complementary Medicines in Australia Part-I – to understand what complementary medicines are and how they are classified in Australia. To […]

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Revised Chinese regulations that brought a lot of changes in clinical trials and product registrations were received with lots of questions. If you have got questions that are yet unanswered, you are not alone. Many researchers, developers and managers are not sure about one aspect or another on how to comprehend, act or change their […]

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