Pharmaceutical Technology, Regulatory Sourcebook, September 2021

Considering interactions and understanding regulatory requirements are crucial when developing a drug or biologic product for use with a medical device.

EFSA’s evaluation of risk in food products raises implications for drug product formulations.

Low- and middle-income countries are at the greatest risk of receiving substandard and falsified COVID-19 vaccines.

The COVID-19 pandemic has further impacted ongoing drug shortage issues; essential action is needed to avoid repeating previous mistakes.

A simplified process flow with associated definitions for pharmaceutical sampling and testing is proposed.

Inconsistent sampling and testing processes can lead to errors, resulting in data integrity issues and potentially incorrect decisions about pharmaceutical quality.

Pharmaceutical Technology checked in with AAPS and IPEC-Americas to get an update on how the organizations are navigating the pandemic and planning for the future.

There are expectations that changes to pharma regulations in the EU, forming part of the regions broader strategy for the industry, will be positive and should offer flexibility for industry to advance through innovation.