Snapshot

The ASEAN Joint Assessment Procedure for Pharmaceutical Products pathway has been developed by the ASEAN-SIAHR of ASEAN.

This pathway can be used where Joint assessment is a formal procedure in which the same application is simultaneously submitted to all participating ASEAN National Medicines Regulatory Authorities (NRAs). Assessment work is then carried out together by all participating NRAs and a joint assessment report is prepared. At the end of the process, the final decision on the application is then taken, within established timelines, by each individual NRA through their normal decision-making process based on the joint assessment report and, where applicable, nationally relevant considerations. Notes announcing priority therapeutic areas and indications will be periodically posted on ASEAN NRAs websites inviting expressions of interest from applicants for the submission of applications for JA candidate product selection. Although there is preference for products within the priority areas, applicants can submit applications for other products - outside priority areas - for consideration by ASEAN NRAs as long as the products have already been approved by a reference NRA, prequalified by WHO, or assessed through special regulatory pathways such as EU Article 58 or US FDA tentative approval. In addition, products should be manufactured in a PIC/S-GMP compliant site (documentary verification only, no inspections foreseen)..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Brunei Darussalam Cambodia Indonesia Lao People's Democratic Republic Malaysia Myanmar Philippines Singapore Thailand Vietnam

Applications can be submitted via three (3) different routes: 1) the responsive application route: applications concerning products that are included in the priority lists published by ASEAN NRAs; 2) the proposed application route: applicants propose products that are not included in the priority lists published by ASEAN NRAs; 3) the invited application route: applicants are approached by ASEAN NRAs or WHO and invited to submit an application for a product of important public health value. Only (1) type of regulatory pathway is available, the abbreviated JA procedure by which the full application dossier is uploaded by the applicant to the dedicated IT platform developed by WHO. The applicant also provides all participating NRAs with access to detailed assessment reports of the product (scientific evaluation and inspections reports) generated by a reference NRA or WHO. Abbreviated JA procedure: In this pathway, all participating NRAs access the full product dossier and the assessment reports and conduct the joint assessment of the entire dossier through appropriate collaboration mechanisms. During the product assessment, the ASEAN NRAs take into account and give significant weight to the assessment performed by the reference NRA or WHO to reach their joint regulatory decision. After completing the joint review, if the outcome of the product benefit-risk evaluation is positive, recommendation to grant national authorizations to the product will be provided. The Abbreviated JA procedure entails the following steps: 1. Applicants express their interest in participating using the standard form Applicant Expression of Interest - AEOI (Annex 1) and, when necessary, form Applicant Expression of Interest - AEOI1 (Annex 1a). By submitting an Expression of Interest, applicants undertake to share the same information with all participating NRAs on all aspects of quality, safety and efficacy of the specified medicinal products along with information on variations implemented and/or planned. Communication related the JA procedures should be addressed to JACG Chair and Co-Chair with a copy to WHO. 2. Chair/Co-Chair with the support of WHO seeks concurrence and confirmation from all participating NRAs to accept Expression of Interest. If at least three participating NRAs concur, Chair/Co-Chair with the support of WHO requests applicant to submit a full application (see point 3 below) and a copy of a letter authorising reference NRA3 or WHO to share confidential information on the product and its assessment and inspections’ reports. 3. Applications must comply with the following aspects: a) the technical application dossier must include the same technical information as that submitted to reference NRA or WHO; b) the technical part of the dossier in ACTD or ICH-CTD format shall be provided in electronic form to be uploaded to a dedicated, secure web site set up by WHO (Joint Assessments Information Management System (JAIMS); only participating NRAs will be able to access the dossiers; c) administrative part of dossier specific to each participating NRA requirements will be submitted directly to each participating authority; d) fees as required by each participating NRA will be paid according to normal national procedures. 4. The administrative part of the dossier, including fees when applicable, shall be submitted individually to all participating NRAs following locally applicable procedures. The technical part of the dossier shall be uploaded to the JAIMS platform. Review of applications will start as soon as the dossier is available on the platform and/ or specific national requirements, to be announced as applicable by concerned NRAs, have been met. 5. The Lead NRA coordinates and facilitates the implementation of the procedure and acts as ‘rapporteur’. The Lead NRA will undertake the following steps: a) verify that all participating NRAs have appointed staff for the joint assessment and received credentials to access JAIMS; b) verify that applicant’s submission is completed; c) ensure that exchange of letters for sharing documentation is completed; d) request reference NRA to share confidential information and assessment and inspections’ reports in English; e) lead the assessment of application dossier, coordinate the preparation of List of Questions (LoQ) and draft assessment report and circulate to participating NRAs (work sharing among all participating NRAs is encouraged), where a physical or virtual meeting will be conducted within the 90 days of evaluation to enable the participating NRA’s assessors to discuss and exchange the preliminary results of their assessment, as well as to seek further expert’s opinions/inputs on the assessment of the particular product. f) receive comments by participating NRAs about draft assessment report and, if applicable, need to request additional information from applicant; g) coordinate the review of feedback from applicant, if applicable; h) set date for assessors from participating NRAs to participate in JA session; i) coordinate with WHO and/or expert(s) from reference NRA for participation in JA session. 6. An exchange of formal agreement letters takes place, facilitated by WHO, between participating NRAs and either reference NRA or WHO (in the case of products prequalified by WHO). 7. There could be situations in which a product proposed for JA is already authorized for marketing in one or more AMS. In these cases, the NRA that has already approved the product decides if it wishes to participate in the JA anyway. The applicant must act according to the NRA decision and accept participation in the JA procedure. The outcome of the JA may result in no change, in a variation to the existing marketing authorization, or in a new marketing authorization. 8. Participating NRAs confirm their access to the application and reference documentation from reference NRA or WHO, assess the application and note their observations, if any, in the JAIMS platform. Observations may entail requesting additional documentation from the applicant. In this case, the Lead NRA will ensure that all observations have been received, consolidate them in a single document, and then notify the applicant as required. The time frame is suspended until response is received from the applicant addressing the observations raised. 9. After the feedback from the applicant has been received, the Lead NRA coordinates its review and the preparation of a draft joint assessment report. If all participating NRA concur with the conclusions stated in the draft report and deem unnecessary to raise further matters, then the report is formally transmitted to all participating NRAs for national decision-making. If one or more participating NRAs deem necessary a face-to-face discussion, the Lead NRA organizes a JA session with support from WHO. 10. At the request of participating NRAs through the Lead NRA, WHO will facilitate the participation of one or more senior assessors from a reference NRA or WHO in a JA session. 11. JA reports are confidential documents belonging to the participating NRAs. After receiving a JA report, each participating NRA is expected to take a decision on the application at their earliest decision-making meeting within the timelines provided below. NB: An abbreviated JA procedure can only be initiated with a minimum participation of three NRAs using the dedicated IT platform developed by WHO enabling applicants to submit a dossier only once for all participating authorities. The ASEAN Joint Assessment procedure is 150 calendar days; 140 calendar days if JA meeting unnecessary. Target times for decisions to be made by individual countries vary as follows: ASEAN Member State Timeline (working days) Brunei Darussalam 60 Cambodia 90 Indonesia 45 Lao PDR 45 Malaysia 30 Myanmar 90 for normal situation and 60 for urgent public health needs situation Philippines 30 Singapore 30 Thailand 30 Viet Nam 60 The invited applications route: is a faster procedure that can be proposed by any ASEAN NRA when a particular product is deemed to be of high public health interest for several ASEAN member countries and suitable for the JA process. The proposing NRA will prepare and circulate a short note describing the product and seek other NRAs endorsement of the proposal to conduct a JA. The product concerned may belong to any therapeutic group and does not need to match the criteria already published by ASEAN NRAs. Applicants or WHO may approach any ASEAN NRA to propose a product to be jointly assessed. The NRA receiving the proposal will decide whether this merit being shared for consideration by the other ASEAN NRAs. The invited application route can be used to conduct the assessment of a complete dossier as in the abbreviated JA procedure).