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​​​​Directives
  • Directive for Topical Diclofenac products

  • Directive on the Control of Nitrosamine and / or Azido Impurities in Medicinal Products
    • Directive on  the Control of Nitrosamine and / or Azido Impurities in Medicinal Products
    • Annex A: Supporting Documents for Importation of ARBs, Metformin, Amitriptyline, Ranitidine and Varenicline containing products
    • Annex B: Flowchart for Control of Nitrosamine and / or Azido Impurities in Medicinal Products​

  • Directive for Products containing Angiotensin-II Receptor Blockers (ARBs)

  • Directive for Carbocisteine containing products

  • Directive for Bromhexine containing products

​Joint Assessment Coordinating Group (JACG)


The National Medicines Regulatory Authorities (NRA) of ASEAN Member States have developed a new procedure for marketing authorizations: the ASEAN Joint Assessment Procedure. The pilot JA project supported and advised technically by the WHO which started in July 2017 has completed. This is a public announcement for a new JA candidate product.