Danish, German, Dutch, Norwegian and Swedish authorities prepared the restriction proposal of around 10 000 per- and polyfluoroalkyl substances (PFASs).

The pharmaceutical industry is calling for a modernization of the current variations system to reflect advancements in technology and regulatory needs.

In March this year World Health Organization (WHO) published a draft guideline on GMP for excipients used in pharmaceutical products.

ISO 13485 is the internationally recognized quality management standard for medical devices. It outlines a set of quality management requirements that must be met by medical device suppliers and service providers. This article provides an overview of the standard, including its requirements, who should use it, and how to use it.

The ICH published a 29-page presentation on the revision of ICH Q9 on 14th of March 2023.

The assessment report of the CHMP’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products provides general guidance and recommendations on mitigating and preventing the presence of nitrosamines in human medicinal products.

To ensure effective planning and execution of a clinical performance study, it is recommended to generate a clinical performance study protocol (CPSP), also referred to as a clinical performance study plan in the In Vitro Diagnostic Regulation 2017/746.