As it is quite inevitable that the transition period for the Brexit is not going to extend, numerous Regulatory changes or updates are expected to emerge from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). In the same context, MHRA has recently issued a guidance on pharmacovigilance procedures and post transition requirements for Qualified Person Responsible for Pharm
-
October 13, 2020 Pharmaceutical, Regulatory Affairs -
October 8, 2020 Pharmaceutical, Regulatory AffairsIt is a known fact that the UK has officially left the European Union (EU) on January 31, 2020 and it is in the transition period until December 31, 2020. During the transition period, all the pharmaceutical companies in the UK must abide by the EU pharmaceutical law.
-
October 6, 2020 Compliance, Audit and Validation, Pharmaceutical, Regulatory Intelligence, Regulatory AffairsAs we all aware, COVID-19 pandemic resulted in the suspension of regular on-site inspections and as the world is slowly coming out of COVID-19 restrictions, Health Agencies are eying on resuming the on-site inspections.
-
October 6, 2020 Pharmaceutical, Regulatory AffairsSince the discovery of nitrosamine impurities as human carcinogens in mid-2018, FDA has been investigating and conducting a detailed analysis of the impurities in human drugs and APIs.
-
Health Based Exposure Limits (HBELs) - Regulatory Expectations and Challenges An Informative Webinar
October 5, 2020 PharmaceuticalPharmaceutical companies sometimes manufacture the products using multipurpose manufacturing facilities to develop different medicinal products. Production at such facilities may create potential cross-contamination and pose a risk on products’ safety and efficacy.
-
October 5, 2020 Pharmaceutical, Regulatory Affairs, Publishing & SubmissionsAccording to the US Food and Drug Administration (FDA), a majority of prescribed pediatric drugs are not tested. To overcome serious shortage of pediatric drug testing, FDA has issued a final guidance that offers a comprehensive framework for planning and submission of applications for pediatric trials.
-
September 28, 2020 Pharmaceutical, Regulatory AffairsWater is considered as a key ingredient in many pharmaceutical and life sciences operations. It is widely used as raw material, ingredient, solvent, active pharmaceutical ingredient (API), intermediate product, and in the formulation/manufacture of pharmaceutical products.
-
September 17, 2020 Compliance, Audit and Validation, Pharmaceutical, Regulatory AffairsPost-Brexit, the biggest challenge for the pharmaceutical industry is its potential implication on Regulatory affairs. The derogation as a result of post-Brexit is expected to hit the pharmaceutical industry extremely hard, especially the Pharma companies operating in the UK.
-
June 11, 2020 Medical Devices, Pharmaceutical, Regulatory AffairsIn the face of COVID-19 emergency, the European Medicines Agency (EMA) established faster scientific advice, rolling reviews and accelerated assessments to expedite the development and approval of medicinal products. EMA’s foresight is to support the development and marketing authorization of safe, effective and high-quality therapeutics and vaccines at the earliest.
-
February 27, 2020 Medical Devices, PharmaceuticalOn January 31, 2020, the United Kingdom (UK) officially left the European Union (EU) making the Brexit come alive. In the light of Brexit, the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have released certain Regulatory guidelines to ensure both pharmaceutical and medical device manufacturers are ready for the transition period.