Pharmacovigilance (PV) involves activities for detecting, assessing, understanding, and preventing adverse drug effects/adverse events (AE) of drug products to ensure the safety of the patients.
- March 3, 2023 Pharmacovigilance
- March 1, 2023 Food and Food Supplements, Regulatory Affairs
The Food Safety and Standards Authority of India (FSSAI) has released comprehensive Regulatory standards to identify basmati rice. This is the first time in the country that FSSAI has come up with a regulation that will establish ethical trading standards for basmati rice, which will also safeguard consumers' interests both domestically and internationally.
- February 27, 2023 Medical Devices
Near-patient Testing (NPT) has the fastest-growing market in the IVD segment. Europe is the second-largest market after the United States for NPT. Many companies are trying to launch their NPT products in the European Union (EU), and now with the implementation of In Vitro Diagnostic Medical Device Regulation (EU IVDR) 2017/746, the companies are transitioning towards it.
- February 27, 2023 Medical Devices
One may think that placing a medical device on the market is the final step; however, even after the device’s launch, the manufacturer is required to fulfill the Post-Market Surveillance (PMS) requirements.
- February 27, 2023 Medical Devices
A medical device Regulatory strategy is a plan for ensuring that a medical device meets all relevant Regulatory requirements before it is marketed and used in clinical practice. This typically involves conducting pre-clinical and clinical testing to demonstrate the device's safety and effectiveness and submitting the results to Regulatory authorities for review and approval.
- February 27, 2023 Medical Devices
A “predicate device” is a medical device that has been previously approved by the US Food and Drug Administration (US FDA) and is already on the market, which serves as a reference point for new medical devices seeking approval through the FDA’s …
- February 24, 2023 Regulatory Artwork Services, Regulatory Affairs
Manufacturing counterfeit and fraudulent items are highly profitable, particularly in the pharmaceutical industry. The illicit market for prescription medication has become a global menace, with patients' lives at risk as it continues to flood hospitals and pharmacies worldwide.
- February 24, 2023 Medical Devices
China is a major player in the medical device industry, and with its diverse population and expanding healthcare market, companies need to understand the necessary clinical trial requirements for medical device products in this region. The Chinese government has implemented a variety of regulations to ensure the safety and efficacy of medical devices being placed on the market.
- February 23, 2023 Regulatory Software & Services
Submission excellence can bring benefits to organizations and enhance the ability to launch products more quickly. It cuts short the delay in the process by simplifying and streamlining the organization’s ways of working.
- February 22, 2023 Pharmaceuticals, Regulatory Affairs
Latin America and the Caribbean (LAC) region is one of the world’s top emerging markets. Mexico, a part of the LAC, is full of opportunities, and expanding in Mexico can prove to be a game changer for global pharma manufacturers.