New WHO Guideline Package: TRS 1060 published

Recommendation
14-16 October 2025
GMP Compliance and Technology for the Manufacture of Oral Solid Dosage Forms
In March 2025, the WHO published a series of new and updated guidelines relevant to pharmaceutical manufacturing, testing and development as part of Technical Report Series No. 1060 (TRS 1060). The associated guidelines are attached to the TRS as annexes. Annexes 2 to 9 of the report cover topics such as nitrosamine control, GMP for excipients, bioanalytical methodology, biowaivers, regulatory co-operation and the graphical representation of chemical structures. The following table provides a structured overview of these guidelines, their scope of application, status (new or revised) and the main contents and changes.
Annex | Guideline Title | Relevance | New or Update | Changes in Comparison to previous Version |
2 | WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products | Manufatcure,Quality Control | New | Introduction of risk assessments for nitrosamine contamination, recommendations for the control and monitoring of nitrosamines |
3 | WHO good manufacturing practices for excipients used in pharmaceutical products | Manufacture | New | Definition of GMP requirements for excipients, including quality management and supplier qualification |
4 | Good practice guidelines for blood establishments | Manufatcure,Quality Control | Update | Updating the guidelines for blood centres, including safety and quality requirements |
5 | WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines... | Development, Authorisation | New | Introduction of a list of medicinal products for which in vivo bioequivalence studies can be waived |
6 | Guideline on bioanalytical method validation and study sample analysis | Testing | New | Definition of requirements for the validation of bioanalytical methods and the analysis of study samples |
7 | Good practices of national regulatory authorities in implementing the collaborative registration procedures... | Authorisation | New | Recommendations for national authorities to cooperate in the registration of medicinal products |
8 | Collaborative registration procedure between WHO and national regulatory authorities in the assessment... | Authorisation | Update | Update of the procedure for accelerated national registration of WHO pre-qualified products |
9 | Guidance for the graphic representation of chemical structures of pharmaceutical substances in the publications... | Development, Documentation | New | Recommendations for standardised graphical representation of chemical structures in WHO publications |
For further information please see the new TRS 1060 der WHO.
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