The National Medical Products Administration (NMPA) of China recently released a comprehensive draft amendment for implementing the China Drug Administration Law (DAL).
- September 26, 2022 Biologicals, Generics, Pharmaceuticals, Health Authority Updates
- September 22, 2022 Pharmaceuticals, Health Authority Updates
According to the CMDh practical guidance for Marketing Authorization Holders (MAHs) of nationally authorized products, the evaluation of nitrosamine impurity or cross-contamination in a marketed product is a critical criterion. Nitrosamines are proven to be carcinogenic and can affect the overall output of the formulated product.
- September 21, 2022 Chemicals, Cosmetics Regulatory Services
As public awareness of environmental issues is increasing rapidly, many cosmetic companies are engaging their focus on natural and environment-friendly emulsifiers and chemicals to be used in their products. The advantages of ‘green’ beauty products go beyond fashion. Newer research approaches have outlined the amount of toxicity in conventional cosmetics.
- September 21, 2022 Chemicals, Cosmetics Regulatory Services
Heavy metals are ubiquitously present in the environment surrounding us. Heavy metals containing ingredients such as thimerosal (mercury) and lead acetate were used as cosmetic ingredients in the past. They were also used as reaction catalysts during chemical synthesis and for manufacturing industrial equipment, containers or closures.
- September 21, 2022 Regulatory Affairs, Regulatory Software & Services
Regulations stand crucial for any industry that functions in the Life Sciences domain, which is the third most heavily regulated sector after the Aviation & Financial sectors. Non-compliance with regulations comes at a high cost – the patients’ lives, heavy economic penalties, or loss of reputation. But challenges to this sector comes from various areas.
- September 21, 2022 Pharmaceuticals, Regulatory Affairs
In the European Union (EU), the promotion of medicinal products is governed by advertising laws and regulations.
- September 20, 2022 Generics, Regulatory Affairs, Publishing & Submissions
Advance Therapy Medicinal Products (ATMPs) are novel drugs that meet patients’ specific needs. But they drastically increase the cost of treatment. Generic alternatives provide relief in terms of treatment cost with a quality drug of similar effectiveness.
- September 2, 2022 Medical and Scientific Communication, Regulatory Medical Writing
Social media and other communication technologies are excellent instruments for bringing attention to public health issues and solutions. In addition, these contemporary tools are employed to disseminate misinformation and conspiracies regarding various subjects, such as vaccinations, genetically engineered organisms, climate change, and, most recently, the COVID-19 pandemic.
- September 1, 2022 Medical Devices
Labeling is an integral part of marketing medical devices. The label is a piece of information affixed with the device and/or packaging in a human-readable format. The main purpose of labeling is to provide safety information to users who can be healthcare professionals, consumers, or any other relevant person.
- September 1, 2022 Pharmaceuticals, Regulatory Artwork Services
The rise in Tracking and Tracing (T&T) systems in the pharmaceutical industry can be attributed to the development of novel and patient-centric medicines. Over the years, T&T systems have improved medication for patients by transforming product handling processes without a quality compromise until it gets dispensed by integrating supply chain operations and technology use.