TEST Evaluation of the environmental risks of medicinal products (kostenlose Guideline) Kopie

EMA reported that Scholar Rock Netherlands withdrew its application for Isembyld after evaluation had progressed through the final round of questions. EMA’s provisional view was that the medicine could not be authorised because the applicant had not provided confirmation that the manufacturing site complied with EU GMP requirements.

Supplier management is the systematic management of a company´s relationship with its suppliers. It encompasses supplier qualification and customer audits as described in the following excerpt from GMP:KnowHow Pharmalogistics (GDP).

On 14 August 2026, the US Food and Drug Administration (FDA) announced the publication of a new draft guidance document entitled ‘Container Closure Systems for Human Drugs and Biological Products’.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