GMP Magazine – News

On 14 August 2026, the US Food and Drug Administration (FDA) announced the publication of a new draft guidance document entitled ‘Container Closure Systems for Human Drugs and Biological Products’.

President Donald Trump has named White House aide Heidi Overton to lead the US Food and Drug Administration (FDA). Overton will fill the position previously held by Marty Makary, who left the agency in May. This announcement was made on Trump's Truth Social account on 19 August. Her nomination is subject to confirmation by the Senate.

The IPEC Stability Guide for Pharmaceutical Excipients has been updated and is now available as version 3 (2026), as announced on the IPEC (International Pharmaceutical Excipients Council) website.

On 14 July 2026, the European Parliamentary Research Service (EPRS) published a comprehensive briefing on PFAS (per- and polyfluoroalkyl substances), also known as ‘forever chemicals’. The document is intended to serve as a technical basis for MEPs in their upcoming political decisions on PFAS regulation and summarises the current state of scientific knowledge, regulation and procedures.

The Active Pharmaceutical Ingredients Committee (APIC) has published Version 3 of the document “GDP for APIs: How to Do” (June 2026) on its website. The document provides practical guidance on implementing Good Distribution Practice for active pharmaceutical ingredients.

Australia's regulatory authority, the TGA (Therapeutic Goods Administration), pursues a strategy of aligning its regulatory approaches as closely as possible with comparable international standards. These include the regulatory requirements of the EU, the FDA and the ICH. In this context, around 370 international scientific guidelines have already been adopted.

“Today public health faces a new kind of challenge: speed. Diseases move faster and are more unpredictable than ever, racing across borders and continents.”, said Hadja Lahbib, Commissioner for Equality, Preparedness and Crisis Management, upon signing an EU4Health contribution agreement worth over 4 million euros with the World Health Organisation’s (WHO) Hub for Pandemic and Epidemic Intelligence in Berlin on 24 July 2026.