New WHO Guideline Package: TRS 1060 published

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Recommendation

13/14 May 2025

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GM Requirements for Planning, Qualification and Operation

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