One of the most recent amendments applied in the year 2020 for the labeling compliance of food and drinks is the update of the Nutritional Facts Panel by the United States Food and Drug Administration. It is solely based on scientific information, new nutrition research, and various other inputs from the public.
- April 12, 2021 Food and Food Supplements
- April 12, 2021 Medical Devices
It is well known that from January 1, 2021, medical devices to be placed on the UK market are obliged to follow a new Regulatory regime. Currently, the UK market is a witness to many Regulatory changes, with the impact of Brexit.
- April 1, 2021 Food and Food Supplements
We all are aware of how food and medicine are different in terms of how they individually nourish the body, but both eventually tend to mainly assist in maintaining our health. While we are trying to enhance our immunity, improve our stamina or deal with current chronic health concerns, we sometimes tend to buy unknown food and food supplements, with poor labeling, which can cause more harm than good.
- March 30, 2021 Pharmaceuticals, Regulatory Affairs
ANVISA of Brazil received the approval to become a member of PIC/s (Pharmaceutical Inspection Co-operation Scheme) in November 2020. Considering the pandemic situation, for the first time in PIC/s history, the assessment was completed in a written procedure as opposed to at a meeting; on Jan 1, 2021, the PIC/s committee welcomed ANVISA as their 54th valuable member.
- March 30, 2021 Medical Devices
Maintaining a Quality Management System (QMS) is the foundation to demonstrate Regulatory compliance in the medical devices industry. QMS is a structured system of procedures and processes, covering all the aspects of design, manufacturing, risk management, supplier management, complaint handling, clinical data, storage, distribution and product labeling of medical devices.
- March 30, 2021 Regulatory Artwork Services
Supply Chain, Packaging and Artwork Management System - In Life Sciences, any delay or mishap in the latter two segments will affect the former which results in product not reaching the markets on time and thus leading to heavy cost burden on the companies.
- March 24, 2021 Compliance, Audit and Validation, Regulatory Affairs
National Medicines Regulatory Authority (NMRA) of Sri Lanka has declared the ‘List of Countries’ to be exempted from the manufacturing site audits. Essentially, this list refers to the respective health authorities in the specified countries, also termed as ‘’Reference Countries.’’ The health authorities included in the list are:
- March 19, 2021 Medical Devices
In the context of COVID-19, there is an increasing interest in understanding the PPE regulations. To meet the growing interest, TGA the Australian Regulatory Authority has issued a guidance, which covers an overview of how PPEs are regulated, information for PPE manufactures and the PPE standards.
- March 18, 2021 Chemicals, Regulatory Affairs, Regulatory Software & Services
Under the Classification, Labeling and Packaging of substances and mixtures (CLP) regulation, Chemical companies, who wish to place hazardous chemical mixtures such as paints, coatings, detergents, solvents, etc. in the European market are required to provide notifications of the hazards in their products.
- March 18, 2021 Chemicals, Cosmetics Regulatory Services, Regulatory Affairs
Environmental Protection Agency of the US is prioritizing the attempts to develop and use New Approach Methods (NAMs) for chemical testing. This new approach will help in reducing the usage of animals as subjects in chemical testing while ensuring the protection of human health and the environment. NAMs are equivalent to “alternatives" to animal testing.