The development of In-Vitro Diagnostic (IVD) devices is a classic example in the healthcare sector, where modern technology has enabled healthcare professionals to improve treatment regimes for serious life-threatening health conditions. While Regulatory agencies worldwide are working towards harmonized regulations to market IVDs, China’s NMPA has led to stringent guidelines for the regulation of IVDs in China market.
- March 24, 2023 Medical Devices
- March 24, 2023 Medical Devices, Regulatory Affairs, Regulatory Medical Writing
The analytical performance is described in European Union In Vitro Diagnostic Regulations (EU IVDR) 2017/746 as “the ability of the device to correctly detect or measure a particular analyte.” The analytical performance of any IVD/s is demonstrated based on the analytical performance studies, which are then documented as Analytical Performance Report (APR).
- March 24, 2023 Medical Devices
A Scientific Validity Report (SVR) is a part of the Performance Evaluation Report (PER) under the European Union In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/746 that documents the scientific validation of the IVDs. The SVR supports the device's conformity assessment and for the same one must consider any relevant published literature and standards.
- March 21, 2023 Medical Devices
The European Union Medical Device Regulation (EU MDR) 2017/745 is a regulation that sets out the requirements for medical devices in the EU. The regulation provides the evaluation of medical devices prior to marketing, and one of the key requirements is the need for clinical investigations.
- March 21, 2023 Medical Devices
As stated in the European Union Medical Devices Regulations (EU MDR) 2017/745, clinical investigation, is “any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device” The entire purpose of clinical investigations is to demonstrate that medical devices are safe and effective when used for their intended purpose.
- March 21, 2023 Pharmaceuticals, Regulatory Affairs
In the early years of the next century, the Japanese population is expected to become the oldest in the world. The Japanese government's concentration on post-World War II economic expansion meant that the government fully woke up to the financial implications of having a large elderly population when the oil prices skyrocketed in the 70s, highlighting Japan's economic dependency on global markets.
- March 20, 2023 Food and Food Supplements, Regulatory Affairs
Breast milk is the gold standard for infant feeding and nutrition. Lysozyme and Human Milk Oligosaccharides (HMOs), which specifically promote the colonization of infant-type HRB, are among the bifidogenic components of breast milk.
- March 16, 2023 Pharmaceuticals, Regulatory Labeling
Electronic Product Information (ePI) refers to the electronic version of the Patient Information Leaflet (PIL) that is provided with medicines. The ePI contains important information about the medicine, such as its active ingredients, indications, contraindications, dosing instructions, side effects, precautions, and storage conditions.
- March 16, 2023 Publishing & Submissions, Regulatory Software & Services
Electronic submissions have taken the life science industry's Regulatory space by storm. Majority of the Regulatory submissions are now made using the eCTD format globally. The benefits of eCTD are undeniable - faster, more efficient, and standardized. But transitioning from non-eCTD electronic Submission (NeeS) to eCTD isn't always a cakewalk.
- March 15, 2023 Pharmaceuticals, Compliance, Audit and Validation, Regulatory Affairs
Audits and adherence to dynamic regulations have posed serious challenges for various pharmaceutical organizations. To list down the forthcomings of pharma audits, FDA warning letters and compliance adherence letters are endpoints, thereafter the compliance bridging is in the hands of pharmaceutical companies.