An ASEAN Mutual Recognition Arrangement (MRA) for Bioequivalence (BE) Study Reports of Generic Medicinal Products was signed on 2nd November 2017 in Manila, Philippines by Ministers of the 10 ASEAN Member States.
ACCSQ Pharmaceutical Product Working Group (PPWG) has endorsed 3 manuals in connection with this MRA at the 31st PPWG Meeting -2021 .
- Manual for Application of Bioequivalence (BE) Centre to be listed under the ASEAN Mutual Recognition Arrangement (MRA) on BE Study Report, version 0
This document sets out to outline the process for listing of BE Centres, which includes application procedures, decision process, appeal and complaint procedures as guidance for BE Centres in ASEAN to be listed under the MRA for BE Study Report. The current scope of the MRA on BE study Report will cover immediate release, oral, solid dosage forms with systemic actions only.
The listing of BE centres is a voluntary scheme. Any BE Centre located in the territory of the ASEAN Member State is eligible to apply for the BE Centre inspection. The inspection will cover all sites and components which include the clinical site, bioanalytical site as well as the pharmacokinetic and statistical analyses components of BE studies. However, only one clinical site and one bioanalytical site are allowed in the first inspection. Additional clinical or bioanalytical sites will be considered after successful listing of the BE Centre under the ASEAN MRA for BE Study Reports of Generic Medicinal Products.
The BE centre shall be listed under the MRA on the ASEAN website only after the BE Centre has been recognised by the JSC.
- Operation Manual of the Panel of Experts (PoE), version 0
This document sets out to define the terms of reference, the operating and funding mechanisms for Panel of Experts (PoE), the procedure for inspection and procedure for recommendation by PoE to the Joint Sectoral Committee (JSC).
- Procedures and Manual of Joint Sectoral Committee (JSC), version 0
This document sets out to outline the terms of reference, the procedures, competencies and qualification for the establishment of PoE, the requirements, competencies and qualification for appointment of independent experts (IEs) and the procedures for listing, verification and removal/de-listing/appeal of BE Centres located in ASEAN member states territory.
More details can be found in this link : https://asean.org/asean-economic-community/sectoral-bodies-under-the-purview-of-aem/standards-and-conformance/policy-and-guidelines/