- Todos > Quality and Safety: Medicines > Quality Assurance
- Todos > Quality and Safety: Medicines > Regulatory Support
- Todos > Quality and Safety: Medicines > Safety and Efficacy
- Todos > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Palabras clave > Certificates of Pharmaceutical Products (CPP)
- Palabras clave > drug regulatory authorities
- Palabras clave > efficacy and safety of medicines
- Palabras clave > harmonization of medicines regulation
- Palabras clave > International Conference of Drug Regulatory Authorities (ICDRA)
- Palabras clave > medicines regulation
- Palabras clave > national regulatory authority (NRA)
- Palabras clave > pre-marketing safety
- Palabras clave > regulatory harmonization
- Palabras clave > regulatory systems - pharmaceutical innovation
(2019; 10 pages)
The 18th International Conference of Drug Regulatory Authorities (ICDRA) was held in Dublin, Ireland from 3 to 7 September 2018. The event was co-hosted by the Health Products Regulatory Authority (HPRA) of Ireland and the World Health Organization (WHO).
More than 300 delegates from regulatory authorities of WHO Member States participated in the 18th 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 sessions and finalized following the consultations with the participants. Feedback, particularly from non-participating authorities, is welcome.
Several common cross-cutting themes emerged from the discussions. These can be further grouped and consolidated and include e.g. promoting regulatory collaboration, convergence and harmonization throughout the products life cycle; improving coordination, risk-based prioritization of investments, reliance, work- sharing and use of regional networks; promoting greater transparency, awareness and communication; enabling regulatory preparedness for public health emergencies; enabling access to innovative medical products; development of international standards; and provision of technical assistance to support implementation.
WHO intends to further develop a 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 in 2019, and the outcomes of the deliverables will be presented to the 19th ICDRA in 2020.