Regulatory

Over the last five years, biosimilars have progressively gained traction. Global sales are expected to more than double to $15 billion by the early 2020s, with emerging markets accounting for $5 billion to $8 billion. Multinational organizations seeking their entrance into emerging markets of the world focus on the biologic-treatment rates of countries and are […]

In 2019, the African Union’s Bureau of Heads of State and Government approved a new Treaty for the establishment of the African Medicines Agency (AMA) to improve countries’ ability to regulate medical products. It appeared like AMA will become a reality now that 15 African Union Member States have ratified the Treaty in recent months.

Knowledge Management Regulatory Affairs (KMRA) has been a recognized discipline in other sectors for over 20 years, but it has taken a long time for the biopharmaceutical business to debate and formalize it. When the ICH guideline paper Pharmaceutical Quality System: Q10 was published in 2008, it highlighted knowledge management as a major enabler of

IDMP is a progression of five specific guidelines established by the International Organization for Standardization (ISO) that emphasize different identification standards in the pharma industry. These standards establish an internationally recognized framework for uniquely identifying and describing pharmaceutical items, as well as for standardized documentation, coding and product information interchange across global regulators, manufacturers, suppliers

The US Food and Drug Administration (FDA) has recently finalized its guidance to generic drug manufacturers on how to seek drug development information through the controlled correspondence (CC) process. This guidance finalizes the draft guidance issued in Nov 2017 and replaces the finalized guidance issued in September 2015. This update on controlled correspondence with FDA

The US generic drug industry has grown into a major component of health care, with generic drugs accounting for the vast majority of retail drug prescriptions dispensed. On August 18, 2017, the President of the USA signed into law the Food and Drug Administration Reauthorization Act (FDARA) including the reauthorization of the Generic Drug User

The pharmaceutical industry is one of the most important industries that will be directly impacted by Brexit. When the United Kingdom’s referendum was held in June 2016, the majority of the British electorate voted for the withdrawal of the UK from the European Union (EU) and now Brexit is a reality. Brexit and its potential

In July 2018, the European medicines regulatory network became aware of the presence of nitrosamine impurities in an Active Pharmaceutical Ingredient (API). This was the first time that a nitrosamine impurity had been detected in a pharmaceutical drug. The unexpected delivery of these impurities resulted in voluntary product recalls on a mass scale and led