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- Tous > Quality and Safety: Medicines > Regulatory Support
- Tous > Quality and Safety: Medicines > Safety and Efficacy
- Tous > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Mots-clés > ATC/DDD Classification
- Mots-clés > harmonization
- Mots-clés > International Conference on Harmonisation (ICH)
- Mots-clés > international harmonization
- Mots-clés > International Nonproprietary Names (INN)
- Mots-clés > post marketing surveillance
- Mots-clés > prequalification of medicines
- Mots-clés > Prequalification of Medicines Programme - WHO
- Mots-clés > regulatory information
- Mots-clés > regulatory matters
- Mots-clés > safety
(2011; 98 pages)
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 outlines regulatory highlights of the period.
The first section is followed by an article on Inspection of API manufacturing sites by the WHO Prequalification of Medicines Programme (PQP). Ensuring the quality of the active pharmaceutical ingredients (APIs) 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).