The Pharmaceuticals and Medical Devices Agency, PMDA, plays three key roles, namely relief services for persons injured by adverse reactions to drugs and regenerative medical products, product reviews, and safety measures.
Based on the concept of the regulatory science, PMDA has been conducting evidence-based review and evaluation, and has been providing citizens and healthcare professionals with rapid access to safer, more effective medical products.
To promote innovative products, PMDA took various measures, i.e. establishment of expedited review tracks and consultation services in response to the needs. Also, the efforts and challenges we face to combat COVID-19 would be introduced in this session.
Today, international collaboration and convergence is necessary and essential in the field of regulatory affairs. PMDA has been continuously contributing to the ICMRA, International Coalition of Medicines Regulatory Authorities, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities. The COVID-19 related issues are hot topics of the ICMRA discussion.
The latest international trends of the regulatory affairs, and current situation and challenges of the development of the products would be introduced in this session.