As the world continues to move towards digitalization, electronic submissions are becoming the norm for Regulatory Bodies across countries. In Europe, the European Union (EU) has established a mandatory electronic Common Technical Document (eCTD) format for the submission of medicinal products’ Regulatory information.
- May 5, 2023 Pharmaceuticals, Regulatory Affairs, Publishing & Submissions
- May 4, 2023 Pharmacovigilance, Pharmaceuticals, Regulatory Affairs
In Pharmacovigilance (PV), the examination of safety signals should be a continuous process, and Manufacturing Authorization Holders (MAHs) must have a well-defined mechanism in place to record, evaluate, communicate, and act on possible PV hazards as needed.
- May 4, 2023 Pharmacovigilance, Pharmaceuticals, Regulatory Affairs
COVID-19 caused major disruption in Pharmacovigilance (PV) efforts, particularly post-marketing surveillance. Due to the pandemic's rapidly increasing volume of data and shifting Regulatory and consumer trends, PV leaders were forced to rethink their traditional safety data management processes and PV technology to bring unprecedented levels of scalability, reliability, and agility to their workflow.
- May 3, 2023 Food and Food Supplements
The Food Supplements industry is one of the fastest-growing industries in the world, and it has been steadily rising in the Indian market. According to a market research report, the Indian dietary supplements market was valued at approximately USD 3924.44 million in FY2020 and is predicted to grow at a Compound Annual Growth Rate (CAGR) of 16% up until FY 2027.
- May 2, 2023 Pharmaceuticals, Regulatory Affairs, Publishing & Submissions
The electronic Common Technical Document (eCTD) is a standard format for submitting pharmaceutical Regulatory material to Regulatory Bodies. Many countries worldwide, including China, have adopted this format.
- April 27, 2023 Medical Devices, Regulatory Affairs
CE marking is mandatory for all devices that are to be sold in the European Union (EU) countries. Similarly, In Vitro Diagnostic (IVD) devices must also obtain a CE marking and undergo a rigorous approval process to demonstrate their safety and efficacy. They have to abide by the requirements mentioned under the EU In Vitro Diagnostic Device Regulation (IVDR) 2017/746.
- April 27, 2023 Medical Devices, Regulatory Affairs
With the implementation of the European Union (EU) Medical Device Regulation (MDR) 2017/745, one of the areas that caught the most attention was the new Post-Market Surveillance (PMS) system for devices. Establishing a PMS for a device has become a mandatory task for manufacturers. The objective behind this stringent requirement is to ensure device safety throughout the product’s lifecycle.
- April 27, 2023 Medical Devices, Regulatory Affairs
Medical devices play a vital role in improving patient health, but non-conformities in the devices can occur even with the best quality control systems in place. Non-conformities refer to instances where a product or a process fails to meet Regulatory requirements, quality standards, or the approved in-house procedures.
- April 27, 2023 Medical Devices, Regulatory Affairs
With the implementation of the European Union (EU) In Vitro Diagnostic Devices Regulations (IVDR) 2017/746, the Performance Evaluation Report (PER) has changed dynamically in terms of its requirements and approach.
- April 20, 2023 Pharmaceuticals, Regulatory Affairs, Regulatory Labeling
Private labeling in the pharmaceutical industry has become an increasingly popular business model in recent years. Private labeling refers to the practice of a company manufacturing a product, which is then sold under another company’s brand name. Essentially, the manufacturer produces the product and allows another company to attach its own label to it.