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, Regulatory Affairs, Regulatory Software & Services
- 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.
- March 17, 2021 Chemicals, Regulatory Affairs
Amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Toxic Substances Control Act (TSCA) requires the United States Environmental Protection Agency (EPA) to evaluate the safety of existing chemicals. How can manufacturers evaluate safety? Here is a stage-wise approach that EPA follows for the chemical risk evaluation process:
- March 16, 2021 Cosmetics Regulatory Services
Are you sure that your cosmetic products or their ingredients are safe for the environment? It’s alarming to hear climatic challenges faced by the world. Maintaining climatic health is one of the major concerns for every individual, and many revolutionary changes have been adopted across various parts of the world to slow down the effects of climate change.
- March 16, 2021 Cosmetics Regulatory Services
Are we really driven towards the fast-paced cosmetic world? The real purpose of using cosmetics is not just to look good to the human eyes, but it also helps to enhance the beauty of the inner self and hence using them has become the core factor. A country like China has broken the momentum and cosmetics is one of the most rapidly growing industries.
- March 15, 2021 Medical Devices
As part of the Safe Medical Device Act in 1990, the FDA mandated the Design History File (DHF), which contains all the development documentation pertaining to a medical device/product/diagnostic, which is generated by the design control process. Preparing a DHF as per the Regulatory requirements and withstanding the Regulatory Agencies’ scrutiny is a key challenge for all the medical devices manufactures and developers.
- March 12, 2021 Cosmetics Regulatory Services
As you may know, South Korea is one of the leading global markets for cosmetic products. However, the impact of COVID-19 has triggered various changes in the regional cosmetics industry. One of the major changes is the shift in consumers’ perception of product safety. Owing to the same, trends like clean cosmetics are expected to increase in South Korea.
- March 12, 2021 Medical Devices
The medical devices industry is considered highly regulated hence device manufacturers must adhere to a strict set of practices, known as, GxP or Good Practices (GMP - Good Manufacturing Practice, GDP - Good Distribution Practice, GLP - Good Laboratory Practice, GCP - Good Clinical Practice and many more).
- March 1, 2021 Medical Devices
The Union Ministry of Health (MoH), India has released a draft Gazette Notification – Medical Devices (Amendment) Rules, 2021. These rules are an amendment to the original “Medical Devices Rules, 2017”, published on January 31, 2017, in the Official Gazette under the Notification No. G.S.R.78(E). The amendment rules read –
- March 1, 2021 Medical Devices
Health Canada has clarified its stand on the research use only testing kits related to COVID-19. Health Canada regulates the import and sale of medical devices and IVDs (In-vitro Diagnostic Devices) in the Canadian market.