Author: Feasibility Team

0

Regulatory Approval For Nutraceuticals (Complementary Medicines) In Australia Part-III

Do you know? Global regulators consider Australian Nutraceuticals complementary medicines () the consumer protection benchmark. In Australia and internationally, numerous complementary medicines are considered premium brands. That is obvious because the complementary medicines’ approval follows a strict regulatory regime and is one of the stringent in the world!. With such high quality of these products, the Australian complementary […]

Read More →
1

What You Need to Know to Register Nutraceutical, Dietary Or Food Supplement Products In Europe – Part I

Nutraceuticals, dietary supplements, or food supplements, also known as “Health Supplements,” have been used for years to maintain, enhance, and improve the healthy function of the human body. They may contain a combination of vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances. Each country differs in its regulatory requirements for registration […]

Read More →
2

Regulatory Approval For Nutraceuticals (Complementary Medicines) In Australia Part-II

Concerning the safety, efficacy, and quality of the product, Australian regulators review and register nutraceuticals, same as pharmaceutical products, concerning the safety, efficacy, and quality of the product. To register herbal, animal, cosmetics, vitamins, or mineral products in Australia, one needs to take the route of the Complementary registration process. Read the first part of […]

Read More →
2

Clinical Trial Requirements and Practical Scenario for Marketing Approval in China

Do you know any product segment where one does not get to encounter Chinese products? Well, hardly any. It has been the focus of the Chinese government for the past several decades to dominate various industrial sectors, including pharmaceuticals. While China has been the big production factory for generic drugs and API ingredients for many […]

Read More →
2

Regulatory Approval For Nutraceuticals (Complementary Medicines) In Australia Part-I

Do you wish to market your nutraceuticals/complementary medicines (vitamins, minerals, nutraceutical products, dietary supplements, and herbal products) in the Australian market? Then it is better to realize that the Australian regulatory requirements are different from other countries for such products. For example, in the United States of America (USA), by filing the GRAS status (Generally Recognized […]

Read More →
2

Thailand Latest Approved IRB List: Update 2

Thailand FDA periodically releases a list of institutional review boards (IRBs) / ethics committees (ECs) that it recognizes for acceptance of clinical trials. Under Thailand’s regulatory system, approved ethics committees serve as the main point of approval for initiating clinical trials in the country. It has been explained in our previous articles (see Part I […]

Read More →
0

What is the best EDC system / eCRF you’ve ever used? Review of online user-initiated surveys on social media

A case record form (CRF) is a great and necessary tool used in clinical trials to collect data from each participating patient. CRF (also referred to as case report form) has historically been on paper (unlike electronic ones these days). Traditionally, something like carbon copy paper, where the sponsor can utilize one sheet for the Trial Master […]

Read More →
4

Clinical Trial Feasibility – Important Tool Before You Conduct Clinical Trial

Conducting clinical trial feasibility is one of the first and crucial steps involved in any clinical study process. Clinical trial feasibility helps in assessing the potential of investigators, the country’s potential for conducting the trial, and many more aspects involved to execute a clinical trial successfully. Clinical trial feasibility Clinical trial feasibility is an assessment […]

Read More →
2

Philippines – Clinical Trial Regulatory Process

The Philippines is a country with a large population and a wide network of hospitals, medical centers, and healthcare professionals, making it a fertile platform for conducting clinical trials. In clinical trials, the Philippines ranks number three in Southeast countries (US NIH) and ranks number eight worldwide (European Medicines Agency reports). Clinical trial statistics in […]

Read More →
0

Pancreatitis – Global Clinical Trial Feasibility

Pancreatitis, inflammation of the pancreas, is the leading cause of GI-related hospitalizations in the USA and many other countries, with a medical condition requiring emergent care. The yearly incidence of Acute Pancreatitis in the United States and western countries is approximately 70-80 new cases per 100,000 population and has increased over the last decade. In […]

Read More →