All comments can be sent at [email protected]. Deadline of submission of comments shall be by 28 August 2020.
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.