- Palabras clave > Good Regulatory Practice (GRP)
- Palabras clave > harmonization of pharmacovigilance
- Palabras clave > International Conference of Drug Regulatory Authorities (ICDRA)
- Palabras clave > medicines regulation
- Palabras clave > medicines regulatory systems
- Palabras clave > National Medicines Regulatory Authority (NMRA)
- Palabras clave > regulatory framework
- Palabras clave > regulatory harmonization
- Palabras clave > regulatory institutional capacity
- Palabras clave > substandard/spurious/falsely-labelled/falsified/counterfeit medicines (SSFFC)
(2017; 11 pages)
The 17th International Conference of Drug Regulatory Authorities (ICDRA) was held in Cape Town, South Africa, on 29 November–2 December 2016. The event was co-hosted by the Medicines Control Council (MCC) of South Africa and WHO.
More than 360 delegates from regulatory authorities of WHO Member States participated in the 17th ICDRA. The recommendations as presented at the end of the conference are set out on the following pages. They are reproduced here as provided by the moderators in the closing plenary session.
Several common cross-cutting themes emerged from the discussions. These can be further grouped and consolidated and include e.g. improving coordination, reliance, worksharing and use of regional networks; promoting greater transparency, awareness and communication; enabling preparedness to facilitate crisis management; development of international standards; and provision of technical assistance to support implementation.
WHO intends to develop a further more concise iteration of these recommendations in the form of a work plan, integrating any feedback received and ensuring greater alignment and consistency across the various work streams. This work plan will be prepared later in 2017, and the outcomes of the deliverables will be presented to the 18th ICDRA in September 2018.