Strengthening Pharmaceutical Regulatory Systems in the Asian Region
Strong pharmaceutical regulatory systems help to ensure the availability and appropriate use of safe, quality-assured, and effective medicines. Yet, many regulatory authorities face capacity limitations that may result in substandard and falsified products on the market; low or poor access to and availability of lifesaving medical products; proliferation of unsafe products that expose the public to adverse events; and poor health outcomes that may cause lack of confidence in the healthcare system and compromise the general safety of the public.
On July 12 and 13, 2023, MTaPS hosted a regional webinar series on Strengthening Pharmaceutical Regulatory Systems in the Asian Region. Speakers from a variety of organisations (WHO, SEARO, SEARN, PQM+, MTaPS, TGA, Nepal DDA, DGDA Bangladesh) provided insight on what regulatory authorities and regional networks are doing to strengthen regulatory systems in Asia and also highlighted needs and gaps for RSS in the region, as well as strategies and interventions to address them.
Workshop objective: To convene key regulatory regional networks and national regulatory authorities to discuss progress in advancing medicine regulatory systems in Asia, with the aims of:
- Understanding what regulatory authorities and regional networks are doing regarding regulatory systems strengthening in the Asian region.
- Discussing existing needs, and gaps in regulatory system strengthening.
- Discussing strategies and interventions to address identified gaps.
- Sharing approaches and methods used by USAID MTaPS program to improve specific regulatory system functions.
The full session recordings and session presentations are below. To learn more about MTaPS’ approaches and tools for strengthening pharmaceutical systems, please click here.
Recordings:
Session 1 (July 12, 2023)
Duration: approximately 2.5 hours
Topics covered:
- Status of pharmaceutical regulation globally (WHO)
- Regulatory system gaps in Asia (MTaPS )
- Pharmaceutical registration system in Nepal (Nepal DDA)
- Regional capacity-building strategies for pharmaceutical regulatory system (WHO SEARO)
- Evidence-based approach to developing the regulatory workforce (MTaPS)
- Minimum common standards for regulatory information management systems (MTaPS and PQM+)
- Regulatory information management systems (MTaPS)
Session 2 (July 13, 2023)
Duration: approximately 2.5 hours
Topics covered:
- Enhancing regional collaboration through convergence and harmonization of medicine regulation (SEARN)
- Case study on convergence and harmonization: Australia (Australia TGA)
- Convergence of technical standards (MTaPS)
- Developing joint assessment procedures for product registration (PQM+)
- Lessons on convergence and harmonization from regional implementing partners (MTaPS)
- Effective medicines registration systems and collaboration with regional networks: Country experiences (DGDA Bangladesh)
