International ? WHO joins collaboration on GMP inspection of API manufacturers

摘要

The World Health Organization has joined the ongoing international collaboration involving EU, US and Australian drug regulators on good manufacturing practice inspections of active substance manufacturers'. In addition, clear criteria have been established for new participants to be accepted onto the programme and also to maintain consistent standards among existing participants2.The WHO joined the collaboration through its pre-qualification of medicines programme, which aims to facilitate access to medicines that meet unified standards of quality, safety and efficacy. Its membership is expected to support efforts by the collaboration towards ensuring the availability of safe and effective medicines. Other members of the collaboration are the European Medicines Agency, EU member states, the European Directorate for the Quality of Medicines and Healthcare, the US Food and Drug Administration and Australia's Therapeutic Goods Administration3