The Center for Drug Evaluation under the National Medical Products Administration (NMPA) has launched a new Registration Service Platform to enhance “Internet + government services” for pharmaceutical companies and the public, improving transparency and efficiency in drug registration processes.
Key Highlights:
- Policy Focus:
- Digital transformation of drug registration services to improve accessibility, efficiency, and transparency.
- Scope:
- Covers the entire drug registration lifecycle, from pre-registration to post-marketing activities.
- Key Features / Functionalities:
- End-to-End Registration Guidance: Comprehensive support across pre-registration, clinical trial applications, marketing authorization, post-marketing changes, and re-registration.
- Administrative Process Clarity: Detailed guidance on application acceptance, electronic processing, verification, and certificate issuance.
- Expedited Pathway Support: Information to assist with accelerated approval and market entry processes.
- Industry Feedback Mechanism: Dedicated Administrative Acceptance Mailbox to collect feedback and improve service quality.
- Public Education & Transparency: Provides accessible information on drug review processes, classification systems, and approved innovative and marketed drugs.
- Continuous Optimization: Platform to be regularly updated with enhancements based on user feedback and evolving regulatory needs.
- Regulatory Goals:
- Improve efficiency and quality of drug registration submissions.
- Enhance communication between regulators, industry, and the public.
- Support informed decision-making and greater transparency in regulatory processes.
Select Mandate HA
Select Mandate Function