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Health Sciences Authority
Regulatory Updates

27 July 2015: National Consultation on the Proposed ASEAN Sectoral Mutual Recognition Agreement (NRA) on Bioequivalence (BE) Report

Audiences

Healthcare professional

Industry member

Product type

Therapeutic Products

27 July 2015

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Introduction

As part of ASEAN Vision 2020 adopted by the ASEAN Leaders to create a stable, prosperous and highly competitive ASEAN economic region, the establishment of the ASEAN Economic Community (AEC) by 2015 is the goal of the regional economic integration.  The healthcare sector is one of the twelve priority integration sectors identified for economic integration under the AEC.

To facilitate the realisation of ASEAN Free Trade Area (AFTA) and the Healthcare Economic Integration, the ASEAN Consultative Committee for Standards and Quality Pharmaceutical Product Working Group (ACCSQ-PPWG) was tasked to study the feasibility of ASEAN MRA for pharmaceuticals.

The PPWG, comprising of regulators and key industry associations from ASEAN Member States (AMS), has been working on the ASEAN Sectoral MRA on BE Study Report and its annexed technical guidelines since 2004. The ASEAN Sectoral MRA on BE Study Report is now ready for national consultation. 

Essential Components of ASEAN Sectoral MRA on BE Study Report

The ASEAN Sectoral MRA on BE Study Report comprises two essential components:

  1. Setting up of a Joint Sectoral Committee (JSC) to establish the standards and procedures for listing BE centres located in ASEAN Member States (AMS).

  2. Mutual acceptance of BE study reports from Listed BE Centres located in AMS, and conducted according to harmonised technical guidelines, for purpose of supporting a submission for registration of a generic medicinal product.   

Feedback Sought

HSA welcomes your comments and feedback on the ASEAN Sectoral MRA on BE Study Report and its Annexes.

Please provide your name, the organisation you represent, mailing address, contact number and email address to enable us to follow up with you to clarify any issues, if necessary.

Where possible, you should highlight the provisions in the proposed draft of the Sectoral MRA or the Annex for which you are providing comments on.

Please note that the contents of any written feedback submitted, and the identity of the source, may be disclosed at the conclusion of this consultation. You may request for the feedback provided to be treated with confidence on grounds that the information is proprietary, confidential or commercially-sensitive. Such requests will be taken into consideration.

Period of Consultation

The consultation period is from 27 July 2015 to 21 August 2015

Feedback Channel

Please download and complete this prescribed feedback template [PDF, 233 KB] to submit your feedback to us.

The feedback template may be submitted via Email: HSA_MedProd_Registration@hsa.gov.sg       

Consultation Documents

The Sectoral MRA and annexes are listed below. Please be informed that they are released only for the purpose of consultation and does not represent the final Sectoral MRA and annexes. 

1. ASEAN Sectoral MRA on BE Study Report [PDF, 89 KB]

2. Annex A – Scope of application of the Sectoral MRA [PDF, 29 KB]

3. Annex B – ASEAN Guideline for the Conduct of BE Studies [PDF, 429 KB]

4. Annex C – ASEAN Inspection Criteria for BE Studies [PDF, 183 KB]

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