Essential medicines and health products

WHO Drug Information

Volume 25, N° 1, 2011

Quality Assurance and Safety: Medicines (QSM)

WHO Drug Information

Publication details

Number of pages: 100
Publication date: March 2011
Languages: English


This first issue for 2011 reports the recommendations made at the recent 14th International Conference of Drug Regulatory Authorities (ICDRA) hosted by the Health Sciences Authority, Singapore, and held from 30 November to 3 December 2010. The success of the conference was confirmed by the presence of 345 participants from over 90 agencies. In addition to the event, participants were invited to celebrate thirty years of ICDRAs and an article describing the personal reminiscences of a frequent participant, highlights important regulatory issues discussed since the ICDRA was initiated.

A feature article focuses on Inspection of API manufacturing sites by the WHO Prequalification of Medicines Programme (PQP). Ensuring the quality of the active pharmaceutical ingredient (API) greatly contributes to achieving the objective of building the quality, safety and efficacy into the product. One of the strategies employed by PQP to achieve this is through inspection of API manufacturing sites to assess compliance with good manufacturing practices (GMP) and to verify data submitted in product dossiers.

The section on Safety and Efficacy highlights information on signals and reports of adverse drug reactions, with other news from around the world, including labelling changes. This is complemented by the section on Regulatory Action and News which provides the most recent developments from regulatory authorities, and particularly those having an impact on decision-making and risk assessment.

The latest ATC/DDD Classifications, temporary and final, are included in this issue followed by a section on Recent Publications, Information and Events covering news, reports and documents.

The journal concludes with the 65th Recommended List of International Nonproprietary Names (INN).