Quotable: Top Experts On Policy Hot Topics

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

“I don’t think Korea’s regulatory science is in the early stages. The MFDS has already been devising guidelines and evaluation methods based on science, but now it is taking it more systematically.” Korea Regulatory Science Center’s In-Sook Park on developing a more systematic approach to strengthen Korea’s regulatory framework. Find out more: KRSC Aims To Raise Korea’s Regulatory Science Game

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Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

23 Apr 2025

• By Neena Brizmohun

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

ICH Modernizes Stability Testing Guideline

22 Apr 2025

• By Vibha Sharma

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

21 Apr 2025

• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Global Pharma Guidance Tracker March 2025

09 Apr 2025

• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Brazil’s ANVISA Clarifies Registration Procedures For Biologicals

24 Apr 2025

• By Francesca Bruce

Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.