All comments can be sent at [email protected]. Deadline of submission of comments shall be by 28 August 2020.
- OBJECTIVES
The general objective of this Administrative Order is to provide facilitated registration procedure and review process of drug products, including vaccines and biologicals.
Specifically, this Administrative Order aims to:
- Provide registration procedures for market authorization holders (MAH) of drug products holding current approval from reference drug regulatory agencies and prequalification/ registration;
- Participate in the global or regional collaborative procedures for accelerated registration;
- Identify the reference drug regulatory agencies as the basis for an abridged and verification review registration procedure; and
- Establish strategic assessment and evaluation process of drug products that already passed stringent regulatory approvals from foreign drug regulatory agencies.
- SCOPE AND COVERAGE
This Order shall apply to all MAH of drug products holding current approval/s from reference drug regulatory agencies and/or registered under the collaborative registration procedures.
Read more:->Draft AO on Facilitated Registration Procedure v1.3.1