All Category Archives - Page 34 of 34

Biosimilar Market Authorization in Malaysia

All Category, Case Studies, Regulatory / development

Biosimilar Market Authorization in Malaysia Unlike most small-molecule drugs, which are chemically synthesized with highly predictable structures and functions, biologics and biosimilars are pharmaceutical compounds synthesized or extracted from a biological source, often with much more complex structures. Thus, unlike generic medicines in which the active ingredients are identical to the reference small-molecule drug, biosimilars […]

UK registration of a formulation of a big global brand, sourced from 3rd party CMO

All Category, Case Studies, Regulatory / development

A UK-based global CHC organization wanted to seek MA for a Fixed Dose Combination analgesic formulation. The product was sourced from a 3rd party CMO. Usually, the 3rd party sourcing is required when the in-house pipeline not able to support markets or when there is a local/regional business need for a client. For getting a

UK registration of a formulation of a big global brand, sourced from 3rd party CMO 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 This guidance finalizes the draft guidance issued in Nov 2017 and replaces the finalized guidance issued in September 2015.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 »

Nitrosamine Impurities: A Regulatory Perspective

All Category, Insights, Regulatory / development

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

Nitrosamine Impurities: A Regulatory Perspective Read More »