Articles

The first blog post for this year was on interchangeability. In it I announced that…

The approval of Rybelsus®, which contains the GLP-1 agonist, semaglutide, by the EMA in April…

In the first post in this series on pharmaceutical specifications, I mentioned that characteristics or…

Vienna, June 14, 2023 – The COVID-19 pandemic demonstrated the critical importance of resilient global…

Several attempts have been made in the past ten years or so to establish a…

Nitrosoamine impurities have been a major concern to regulators and the pharmaceutical industry since 2018…

It is widely acknowledged that South Africa needs its own biosimilar manufacturing industry, and in…

The SAHPRA, like many other developing country regulatory authorities with capacity constraints, has implemented in…

After months of writing about it, and even raising the issue among regulatory stakeholders, SAHPRA…

I have written before about insulin – a simple biologic with arguably the least stringent…

https://www.youtube.com/watch?v=ITO49g5BO9A Non-biological complex drugs (NBCDs) represent a class of diverse synthetic drugs midway between conventional…

From the desk of Henry Leng – In my post of three months ago (published…