Skip to main content Skip to search Skip to main navigation

WHO: Draft on Regulatory Ovesight of Disposal of Medical Products

WHO published a draft consultation document on regulatory oversight of disposal of medical products throughout the lifecycle.

Improper disposal of pharmaceutical waste can promote the emergence and spread of antimicrobial resistance (AMR), leading to difficult-to-treat infections. It also poses health risks, including respiratory diseases, endocrine disruption, radiation poisoning, and certain cancers. In addition, pharmaceutical waste can contaminate air, water, soil, and agricultural systems, causing significant environmental and food safety concerns.

WHO recommends that National Regulatory Authorities (NRAs) establish or update legal frameworks for the safe disposal of unwanted medical products. Authorities should implement risk-based inspections, oversee the entire disposal process through appropriate documentation and traceability, license and supervise waste management providers, and introduce controls to prevent diversion, falsification, and environmental contamination. In addition, NRAs are encouraged to provide training, promote public awareness, and strengthen collaboration with environmental and other competent authorities.

Comments should be submitted through the online PleaseReview™ platform by 22 August 2026.

Figure 1 highlights the main pathways of entry of human and veterinary pharmaceuticals into the environment during routine production and use.


Source:

WHO: DRAFT WORKING DOCUMENT FOR COMMENTS: Good practices for regulatory oversight of the disposal of medical products throughout their life cycle

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

News: EMA

EMA Clarifies Batch Numbering for Parallel-Traded Medicines

EMA updated its GMP/GDP Q&A collection by revising the answer to Question 4 concerning Chapter 5 of the EU GMP Guide. It explains which batch numbers should appear on the packaging of parallel-traded medicines.

Read more
Question of the Week | GMP-Verlag

Why is it Important to use Consistent Microbiological Air Monitoring Methods in Pharmaceutical Cleanrooms?

Here's the answer:
Read more
Cleaning Validation: When PDE Reports and the Worst-Case Selection do not Align

Cleaning Validation: When PDE Reports and the Worst-Case Selection do not Align

Robust PDE reports form the basis of risk-based cleaning validation. This article highlights common deficiencies identified during GMP inspections and explains how they can be avoided.

Read more
News: Europe

EDQM: New Working Party on 3D-printed Medicinal Products

The European Pharmacopoeia Commission (EPC) approved the creation of a working party on 3D-printed medicinal products. Its aim is to support the development of appropriate quality standards in the European Pharmacopoeia (Ph. Eur.).
Read more
EMA: 14 New Nitrosamines for Appendix 1

EMA: 14 New Nitrosamines for Appendix 1

Appendix 1 of EMA’s Questions and Answers on nitrosamine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.
Read more
WHO: Draft Revision of its Guidelines on Quality Risk Management

WHO: Draft Revision of its Guidelines on Quality Risk Management

WHO published a revised draft of its “WHO guidelines on quality risk management”. Working document QAS/26.994 is open for public comment until 15 November 2026.
Read more
Previous
Next