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Brief introduction about ASEAN Joint Assessment Procedure for Pharmaceutical Products


 

The ASEAN Joint Assessment Procedure is a procedure in which the same marketing authorization application is simultaneously submitted to all participating ASEAN National Medicines Regulatory Authorities (NRAs).

ASEAN National Medicines Regulatory Authorities (NRAs) includes:

  • Health Sciences Authority (HSA)- Singapore
  • National Pharmaceutical Regulatory Agency (NPRA)- Malaysia
  • Thai Food and Drug Administration (Thai FDA)
  • Food and Drug Administration (Philippines FDA)
  • Badan Pengawas Obat dan Makanan (BPOM),Indonesia
  • Drug Administration of Vietnam (DAV)
  • Ministry of Health, Brunei (MoH, Brunei)
  • Department of Drugs and Food (DDF), Cambodia
  • Food and Drug Administration Myanmar
  • Food and Drug Department (FFD) , Laos

The join assessment procedure is initiated with minimum of 3 NRAs.

At the moment , it covers only :

  1. a) medicines for treatment of priority diseases in ASEAN region such as but not limited to: treatment for specific cancers such as breast , lung, Hepatitis C, treatment of AIDS/HIV, Tuberculosis, Treatment-Resistant Depression.
  2. b) products already approved by a reference National Regulatory Authority(NRA) ,prequalified by WHO-PQP, or assessed through special regulatory pathways such as EU Article 58 or US-FDA tentative approval;
  3. c) products manufactured in a PIC/S-GMP compliant site

Process in brief

  1. Participating National Regulatory Authority(NRA) publish on their website in the form of a Notice : Notices of Invitation to Express Interest.
  2. Applicant can submit their interest by filling up the appropriate application form to the authority.
  3. Lead NRA seeks concurrence of participating NRAs for accepting Expression of Interest
  4. Lead NRA requests applicant to submit required documentation to participating NRAs.
  5. Assessment work is then carried out together by all participating NRAs and a joint assessment report is prepared
  6. At the end of the process, the final decision on the application is then taken, within established time lines, by each individual NRA through their normal decision-making process based on the joint report and, where applicable, nationally-relevant considerations.

Applications must comply to the following:

  1. the technical application dossier must include the same technical information as that submitted to reference NRA or WHO-PQP;
  2. 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; only participating NRAs will be able to access and download the dossiers;
  3. c) administrative part of dossier specific to each participating NRA requirements will be submitted directly to each participating authority;
  4. d) fees as required by each participating NRA will be paid according to normal national procedures.

Processing timeline: 180  working days for assessment procedure

If you have a product that may fall into the therapeutic area mentioned  and need support for submission, please feel free to get in touch with TRC.

Useful references:

  1. List of Priority Products
  2. Processing timelines
  3. ASEAN-JA-Procedure-for-Pharmaceutical-Products-Information-for-Applicants

 

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