It 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.

As 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.

Since 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.

Pharmaceutical 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. Hence, toxicological risk assessment is of utmost importance, to evaluate the possible risks of cross-contamination for medicinal products.

According 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.

’Personalized beauty’ is one of the growing trends in South Korea. Aligning with the trend, to ensure safe and effective custom cosmetics’ supply in South Korea, the Ministry of Food and Drug Safety (MFDS) released a draft detailing the safety rules and specific guidelines for the product manufacturers.

To support manufacturers during COVID-19, the EMA has updated guidance on the Regulatory expectations for the medicinal products. A new section of temporary flexibilities is added to inputs on good manufacturing practices (GMP), and good distribution practices (GDP). The new development is aimed at responding to the increased demand for medicinal products amid COVID-19.

Water 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.

Medical device industry is witnessing rapid Regulatory reforms, thanks to evolving technologies and scientific developments. In this rapid development scenario, to aid medical device manufacturers, notified bodies, and other stakeholders align with the sophistication and globalization, Regulatory bodies are parallelly revamping the compliance standards.

Post-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. Therefore, a careful evaluation of the political situation and Regulatory framework is necessary to learn the consequences.