Despite being one of the most regulated industries in the world, the prevalence of counterfeit drugs is a sad reality in the emerging markets of the pharmaceutical industry. According to a report by the Authentication Solution Provider’s Association (ASPA), the number of counterfeit incidents in India increased by an average of 20% on a year-to-year growth between 2018 to 2020 and 17% between 2019 to 2020.
- October 31, 2022 Pharmaceuticals, Regulatory Artwork Services, Regulatory Affairs
- October 31, 2022 Generics, Regulatory Affairs
Competitive generics are known to be a boon as they pave the way to a lucrative market, provided drug manufacturers can decode the challenging and complicated drug development. Although drug development technologies are constantly evolving, we are yet to comprehend the outcomes of Competitive Generic Therapy (CGT).
- October 28, 2022 Medical and Scientific Communication, Pharmaceuticals, Regulatory Medical Writing
The pharmaceutical and Life Sciences sectors have seen a steady increase in the need for Medical Writing. Patents have been expiring, Regulatory standards have changed quickly, and spending on research and development has been rising constantly. Because of this, the necessity to continuously adapt, produce, maintain, and update medical material has evolved.
- October 21, 2022 Medical Devices, Regulatory Affairs
Medical devices in South Korea are regulated by the Ministry of Food and Drugs Safety (MFDS), formally known as the Korean Food and Drug Administration (KFDA). MFDS requires all foreign manufacturers wishing to market their devices in South Korea to appoint a Korean License Holder (KLH) to register their devices with the MFDS.
- October 21, 2022 Medical Devices, Regulatory Affairs
Medical device manufacturers must include required documentation with every product to help consumers understand its use. This documentation, sometimes, can have a few hundred pages, which is daunting for consumers. Quick reference guides are curated to cover all necessary product information, and the consumers may not have to wade through a ton of content to find it.
- October 21, 2022 Medical Devices, Regulatory Affairs
The Medical Device Single Audit Program (MDSAP) allows a recognized Auditing Organization (AO) to conduct a single audit of a medical device manufacturer’s Quality Management System (QMS). It furnishes relevant Regulatory requirements for five countries, i.e., Brazil (ANVISA), USA (FDA), Japan (PMDA), Canada (Health Canada), and Australia (TGA).
- October 21, 2022 Medical Devices, Regulatory Affairs
The medical devices and In Vitro Diagnostic devices (IVDs) under the European Union Medical Device Regulation (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (IVDR) 2017/746 are categorized into four (04) classes and twenty-two (22) rules (MDR)/ seven (07) rules (IVDR). Compared to the previous scope of the product in the Directives, the current regulation has expanded its scope.
- October 18, 2022 Biologicals, Regulatory Labeling
In the era of personalized medications, precision medicine revolutionized the delivery of biologicals, ensuring safety and efficacy by comprehending the product’s effect at an individual level. Pharmacogenomics (PGx) is one of the components of precision medicine owing to its role in optimal dose selection and effective, dose-responsive, individual identification that can avoid adverse reactions.
- October 18, 2022 Medical Devices, Regulatory Affairs
Digital health technologies have become a focus for investors in the healthcare industry in China. The NMPA has set various laws and policies regulating digital health technologies. The NMPA considers digital devices such as healthcare apps, wearables, and Software as a Medical Device (SaMD) as medical devices under the Medical Device Regulation (Order #739).
- October 17, 2022 Pharmaceuticals, Regulatory Medical Writing
Child-resistant Packaging (CRP) is a type of packaging that is difficult for young children to open (or gain access to the contents) as opposed to adults. CRP reduces child mortality/adverse effects from the unintentional ingestion of oral prescription drugs.