Regulatory Archives - Page 3 of 4

DDReg’s RegTech space: your regulatory solution for achieving rapid market access

All Category, Insights, Regulatory / development

DDreg RegTech focuses on technologies that may facilitate the delivery of regulatory requirements more efficiently and effectively than existing capabilities. The global adoption of RegTech is a result of increased regulatory scrutiny, compliance costs, development of artificial intelligence, evolution of data science and increasing demands regarding cost-effective compliance solutions. With ever changing regulatory requirements, pharmaceutical […]

DDReg’s RegTech space: your regulatory solution for achieving rapid market access Read More »

Biologics development & regulatory approval – EMA perspective

All Category, Insights, Regulatory / development

Biologics development in Biologic medicinal products, particularly biosimilars, has revolutionized the treatment of chronic conditions. As biologic products lose patent protection, biosimilars emerge as more readily accessible treatment alternatives. In the European Union (EU), the European Medicines Agency (EMA) is responsible for product approval. The EMA was the first regulatory authority to establish a regulatory

Biologics development & regulatory approval – EMA perspective Read More »

Biosimilarity and Interchangeability in the MENA region

All Category, Insights, Regulatory / development

A biological drug (or Biosimilar) is one that is produced from a living organism or contains components of a living organism. They have become indispensable tools in modern medicine, for the treatment of life-threatening conditions. With an aging population and a growing demand for treating chronic conditions, biologic use is on the rise. However, they

Biosimilars in the Emerging World

All Category, Insights, Regulatory / development

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

All About African Medicines Agency

All Category, Insights, Regulatory / development

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.

All About African Medicines Agency Read More »

Knowledge Management in Regulatory Affairs (KMRA)

All Category, Insights, Regulatory / development

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

Knowledge Management in Regulatory Affairs (KMRA) Read More »

Identification of Medicinal Products (IDMP) – The Perspective of US FDA & EMA

All Category, Insights, Regulatory / development

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

Identification of Medicinal Products (IDMP) – The Perspective of US FDA & EMA Read More »

Controlled Correspondence with FDA – An Update

All Category, Insights, Regulatory / development

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

Controlled Correspondence with FDA – An Update Read More »

Generic Drug User Fee Amendments

All Category, Insights, Regulatory / development

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

Generic Drug User Fee Amendments Read More »

Impact of Brexit on the Pharmaceutical Industry

All Category, Insights, Regulatory / development

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

Impact of Brexit on the Pharmaceutical Industry Read More »