The Chemical industry is the second-largest manufacturing industry in Japan. With increasing production and use the Chemical Regulatory Authorities of Japan aim to reduce exposure to hazardous chemicals and protect the health of the workers. One of the aspects of sound chemical management is the establishment and implementation of legal frameworks.
- May 17, 2021 Chemicals, Regulatory Affairs
- May 13, 2021 Medical Devices
With the convergence of technologies and the connectivity of medical devices to various networks, there is an increased risk of cybersecurity exploitation, which affects the device’s operation. Hence, it is essential to have an effective medical device cybersecurity system to avoid cyber-attacks and ensure safe medical devices’ functioning.
- May 12, 2021 Medical Devices
With the advent of digitization, many global organizations, especially in life sciences and med-tech industries, have randomly shifted their data from paper to digital forms. Thanks to the stringent regulations, like US FDA’s 21 CFR Part 11 (21 CFR 11) regulation, the digitalized data forms are coming out to be accurate, efficient, productive, quality-oriented and reliable.
- May 11, 2021 Chemicals, Regulatory Affairs
Following the Brexit on 31 December 2020, Great Britain is no longer part of the EU scheme for regulating biocidal products. The existing EU Biocidal Products Regulation (EU BPR) has been transformed to Great Britain Biocidal Product Regulation (GB BPR). However, most aspects of the EU BPR will continue in the same way under the GB BPR.
Here are a few updates on the GB BPR:
Table 1
- May 11, 2021 Chemicals, Cosmetics Regulatory Services, Regulatory Affairs
Over the recent years, there have been concerns about the usage of aluminium in cosmetics and other products such as antiperspirants, toothpaste and lipsticks that come into contact with the human skin. In relation to the same, the European Commission's Scientific Committee on Consumer Safety (SCCS) released its opinion in March 2020.
- May 11, 2021 Medical Devices
In recent times, the use of AI/ML (Artificial Intelligence/Machine Learning) has taken a huge technological sweep in the medical devices and healthcare industries because of their ability to diagnose, manage and treat a wide variety of medical conditions and to enhance the patient care.
- May 11, 2021 Pharmaceuticals, Regulatory Affairs
GxPs are standardized practices defined for drug companies that research, produce, store, distribute or sell pharmaceutical products. GxPs refer to a collection of quality standards and guidelines that are designed to ensure that the safety of the products is maintained across the product lifecycle.
- May 11, 2021 Regulatory Affairs, Publishing & Submissions
The withdrawal of the United Kingdom from the European Union had many concerns. One of them being Regulatory Submissions. To smoothen the submissions process, the EU and the UK have set up a clear set of rules. Many of them are related to the existing and new marketing authorisation applications (MAAs) for CAPs, DCP and MRP, Batch testing, QP Certification, etc.
- May 10, 2021 Food and Food Supplements, Regulatory Affairs
Have we ever realized various processes to consummate the sustainability of the products we manufacture? Won’t it be cumbersome to understand the depth of different market regulations for Food products?
- May 7, 2021 Publishing & Submissions, Regulatory Software & Services
On-time Regulatory submission is the key to achieve quick time-to-market. But, with a lack of planning, the industry could face a lot of complications which may result in rejected submissions, delayed market-entry, increased costs due to extended timelines. Hence, it is necessary to develop a concrete submission plan and identify where technology can help improve Regulatory submissions.