asean stability guidelines for health supplements

Working document QAS/17.694 page 3 Introduction and background36 37 38 The Stability testing of active pharmaceutical ingredients and finished 39 pharmaceutical products was published as Annex 2 in the WHO Technical 40 Report Series, No. �/E�n1��d�_�]�wg�ͪo!|��. �� JFIF ` ` �� C Adoption of ASEAN Guidelines for regulation of Health Supplements was endorsed during the 17th Bhutan Medicine’s Board Meeting. Appropriate guidelines for stability testing of finished herbal products provides manufacturers, regulatory authorities and research institutions with a harmonized system for stability testing. Guideline on Submission Requirements for Risk Management Plan Documents 166 KB. Health supplements that are imported or sold must not contain the following:. Dr Sabine Koppreports on the development of World Health Organization policy on stability testing. �n4��+��@αɩ�19(��U��E]��"�#��:��U�wU�{N��67)�.m�lL�ƕe^�eV6n��1��aI;F��_�~�� ASEAN Guiding Principles for Inclusion into or Exclusion from the Negative List of Substances for Traditional Medicines and Health Supplements Refer to the ASEAN website (click on "POLICY & GUIDELINES" to expand the section and refer to point 11) for the following ASEAN Guidelines developed by the TMHS PWG:. The primary purpose of the Guidelines is to promote investment in food, agriculture and forestry in the ASEAN region that contributes to regional economic development, food and nutrition security, food safety and equitable benefits, as well as the sustainable use of natural resources. ပူးတွဲအပြည့်အစုံဖတ်ရှုပါ ပူးတွဲအပြည့်အစုံဖတ်ရှုပါ ပူးတွဲအပြည့်အစုံဖတ်ရှုပါ E�[�G`q��s�9: �^iL#�Vt��:݄7v`+�t�"��U��V�+�e�j��f3~��ᔙ&�-T,X(m��a� (�^��p��w}�}xX�#3 _��H7��f;��ޣ��,�R[�p.�{�c7N�3�N��Ng�t$�%_��u��.��>\��P��Hl�N�L�7��b�2�i!��m��;��)*]hh%��C�a�(!R�x~2^o{?,?� G3I�RO3�| ASEAN Guideline on Good Manufacturing Practice for Traditional Medicines and Health Supplements 6 Version 1 CHAPTER 1 - QUALITY MANAGEMENT PRINCIPLE Traditional medicines and health supplements shall be manufactured so as to ensure that they are fit for their intended use, comply with the requirements of the Refer to “ASEAN Guidelines on Stability Study and Shelf- Life of Health Supplements”. In many cases, these constituents have only very low concentrations, especially in the finished product. Certain annexures of the ASEAN Guidelines are identically adopted. ASEAN Alliance of Health Supplement Associations (AAHSA) Following the meeting of the ACCSQ TMHS PWG in 2006, the ACCSQ TMHS PWG Scientific Committee (ATSC) was created to assist the TMHS PWG in the study of additional areas for harmonization of traditional medicines and health supplements and provide scientific information and recommendations on the following areas of … ASEAN Guideline on Good Manufacturing Practice for Health Supplements 2 Version 1 whether there are adequate measures to prevent cross-contamination shall be submitted to the NRA during the product evaluation and registration stage for assessment, when required by … Health supplement claims. $.' NSF International has helped create a new voluntary Stability Testing Guideline for supplement manufacturers to ensure they have the necessary data to support expiration dating on product labels. Guidelines. ASEAN Guidelines for Validation of Analytical Procedures; ASEAN Guideline on Stability Study of Drug Product 2013 (20th ACCSQ PPWG) ASEAN 1st Q & A to the ASEAN Stability Guideline R1 (21st ACCSQ PPWG) ASEAN Guidelines for the Conduct of Bioavailability and Bioequivalence Studies; ASEAN Guideline on Process Validation Q&A For the health supplement category, the output expected is the development of an ASEAN Regulatory Framework on Traditional Medicines and Health Supplements and transposition of the ASEAN Regulatory Framework into national laws of ASEAN Member States. Objectives of these guidelines These guidelines seek to exemplify the core stability … Guideline on PRISM Submission 2144 KB (updated 31 Dec 2020) 18. Reporting to ASEAN Consultative Committee on Standards and Quality (ACCSQ) and with the assistance of the ASEAN TMHS Scientific Committee (ATSC), the ACCSQ TMHSPWG is tasked with: Refer to the ASEAN cooperation on standards and conformance to facilitate trade in the region for more information. Guidelines for Vitamin and Mineral Food Supplements CAC/GL 55-2005: vitamin and ... Health Supplements belong to sub-category 13.6 and are distinct from other food International collaboration. ��X�/[E�a��j?$2|z88�Y��.��g3|~f�I�µ��9��QΝ?�R�r��A�K��KU�k��q��W� ICH Q1A (R2) Stability testing of new drug substances and drug products �.�**��*�SJ��+$�X��Z�r��T�58~�żLF�h*��}�Y�[d�V�(�ye"��kY0��\9&��]_V�5�$�:P=��W�P��ǔx�Nj��U:R��V~VO��c[7ߺR|p��~��~y�Z��uS��_X�%RY��e|��T/⭅骋s�3 9. Eliminating technical barriers to trade for TM and HS, without compromising public health and safety to the ASEAN peoples. ASEAN accepts the standard conditions for photo stability testing as described in ICH Q1B. Under the current guidelines for Good Manufacturing Practices (GMPs) for Natural Health Products (NHPs), manufacturers and importers of NHPs are required to ensure that their product expiration dates are supported by adequate stability studies. Understand the regulations on health supplements and permissible health claims before you import, sell or manufacture them in Singapore. x��Y]S7}��w3]��:��P:`��$}0��a�bh˿�ڏ ��Y�%�s�=��&{��o�N��KM��p?~��w��y��w��#�i*�JP�� -ͨ�ď`T�)'�`�)2�n��G�M�9��n��!��2hD��Y��`��='�:C��v�{"�p l�cx�.a��yM��[�#�A�?�[=Xg;�� \�q�qj�7n%�N,D4��q��h6��XGd'*��ꩈM� �d=�R��z��Q٨��H�XH�,Q?#�&`��)� Guidelines for the use of iron supplements to prevent and treat iron deficiency anemia ... Situational analysis of iron deficiency anaemia in South-East Asian countries A regional overview The frequency of testing at real time storage conditions should normally be every 3 months In ASEAN (ASEAN Agreement on Heath Supplements), the following definition has ... food supplements. Under the current guidelines for Good Manufacturing Practices (GMPs) for Natural Health Products (NHPs), manufacturers and importers of NHPs are required to ensure that their product expiration dates are supported by adequate stability studies. Stability Data 13. ASEAN Guidelines on Stability Study and Shelf-Life of Traditional Medicines 5 of 21 Version 1.0 a minimum of three time points, including the initial and final time points, for example, 0, 3, and 6 months for a 6-month study, is recommended. Personal Care Products Council (PCPC): Washington D.C.: s.n., 2011 [10] The primary purpose of the Guidelines is to promote investment in food, agriculture and forestry in the ASEAN region that contributes to regional economic development, food and nutrition security, food safety and equitable benefits, as well as the sustainable use of natural resources. ASEAN Guidelines on Stability Study and Shelf-Life of Traditional Medicines and Health Supplements 5 of 22 Version 1.0 a minimum of three time points, including the initial and final time points, for example, 0, 3, and 6 months for a 6-month study, is recommended. ASEAN Guidelines r arnisain andards 3. %PDF-1.5 Medicine and Health Supplement Registration Requirement N. BUNYAPRAPHATSARA. ICH Guidelines –Q1A (R2) –Stability testing of New Drug Substances and Products –Q1B –Stability Testing: Photostability Testing of New Drug Substances and Products –Q1C –Stability Testing for New Dosage Forms –Q1D –Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products –Q1E –Evaluation of Stability Data This document defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the ICH regions. 2. Although the value they receive depends on the amount of active ingredient present in the product, most regulatory environments don’t require stability studies on the main ingredients. These Guidelines on the harmonisation of standards are established and implemented to define a consistent, effective and sustainable programme for harmonisation of standards They apply to all ASEAN sectors and should be adopted by all AMSs. 5 0 obj Working document QAS/16.694/Rev.1 page 6 101 margin for medicinal products to be marketed in their region than 102 foreseen in ICH Q1F. stream The ASEAN Alliance of Health Supplement Associations (AAHSA) represents the health supplement industry in the member countries of the Association of Southeast Asian Nations (ASEAN).. Made up of seven national health supplement associations, AAHSA works to develop the ASEAN health supplements sector by:. ASEAN Guidelines on Stability and Shelf-Life of Traditional Medicines and Health Supplements -Provide recommendations for conducting a stability study on TMHS and its shelf-life. ASEAN Guiding Principles for the Use of Additives and Excipients in Traditional Medicines and Health Supplements, ASEAN Guidelines on Limits of Contaminants for Traditional Medicines and Health Supplements, ASEAN Guidelines for Minimising the Risk of Transmission of Transmissible Spongiform Encephalopathies in Traditional Medicines and Health Supplements, ASEAN Guidelines on Stability and Shelf-Life of Traditional Medicines and Health Supplements, ASEAN Guiding Principles on Safety Substantiation for Traditional Medicines and Health Supplements, ASEAN Guidelines on Claims and Claims Substantiation for Traditional Medicines and Health Supplements, ASEAN Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements, ASEAN Guidelines on Labeling Requirements for Traditional Medicines and Health Supplements, ASEAN General Principles for Establishing Maximum Levels of Vitamins and Minerals in Health Supplements. The objectives of the ASEAN Agreement on Health Supplements (hereinafter referred to as “Agreement”) are: a) To enhance cooperation amongst Member States in ensuring the safety, quality and efficacy/claimed benefits of Health Supplements marketed in ASEAN region; and, 31 Stability test parameters for different dosage forms are presented in … William Morkel, BSc Senior Quality Assurance and Regulatory Affairs Specialist, dicentra Inc. The guidelines are expected to be made available shortly. Requirements for Registration of Dietary Supplements in ASEAN Countries10 With re… AND HEALTH SUPPLEMENTS 1. Adopted at 20th ASEAN traditional medicines and health supplements scientific committee meeting (ATSC) 26–29 August 2013, Bangkok and endorsed at 20th ACCSQ traditional medicines and health supplements product working group (TMHSPWG) meeting 15–16 November … Consumers increasingly demand food supplements with high quality, safety and efficacy. 953, 2009 (1). This ASEAN General Guidelines on Food Contact Materials provides ASEAN Member States (AMS) with a common set of guidelines for the establishment of control systems for FCM. Advertisements and promotions. .��ImD_G��ڡ��)r�_�b�nǚ�#��9,sT�&��h �Gh� ��e��/��w��J�� It does not cover the information to be submitted for abbreviated or abridged applications, variations and clinical trial applications. 953, 2009 (1). 4 0 obj World Health Organization [9] PCPC. ASEAN (2005) ASEAN guidelines on stability and shelf-life of traditional medicines and health supplements. Convince Member States to consider modelling their technical standards and regulations after ASEAN harmonized technical standards and regulations. endobj Objectives and Scope 3.1. Adopted 6. Following lengthy discussions, the World Health Organization (WHO) has revised its guidelines on stability testing conditions for climatic zone IV, ie hot and humid countries. Find out about the harmonisation efforts of the Product Working Group for Traditional Medicines and Health Supplements (TMHSPWG). In2007, ASEAN decided to accelerate the establishment of this ASEAN economic region by 2015. ASEAN 2 • Brunei • Indonesia • Malaysia ... • Guideline for stability study • Accelerated stability data (6 months) • Real time stability study (2 years) Study Design Check requirements Regulatory overview. From the chemical and analytical point of view, herbal drugs, herbal preparations and HMPs are complex in nature due to the high number of constituents belonging to different chemical classes and having different analytical behaviours (for example, flavonoids versus essential oils). ASEAN Guidelines on Limits of Contaminants for Health Supplements ASEAN Guidelines for Minimising the Risk of Transmission of Transmissible Spongiform Encephalopathies in Health Supplements ASEAN Guidelines on Stability and Shelf-Life of Health Supplements Working document QAS/16.694/Rev.1 page 6 101 margin for medicinal products to be marketed in their region than 102 foreseen in ICH Q1F. NSF International has helped create a new voluntary Stability Testing Guideline for supplement manufacturers to ensure they have the necessary data to support expiration dating on product labels. ��Nps��I endobj Guidelines on Stability Testing of Pharmaceutical Products. Adopted 6. <> Fertility Supplements Market to expand at a CAGR of 7.8% by 2029 - The global fertility supplements market is projected to expand at a promising 7.8% CAGR during 2019 – 2029. –Appropriately located (i.e. ASEAN Guidelines by the TMHSPWG. The primary purpose of the Guidelines is to promote investment in food, agriculture and forestry in the ASEAN region that contributes to regional economic development, food and nutrition security, food safety and equitable benefits, as well as the sustainable use of natural resources. The ACCSQ proposed to Senior Economic Officials during a SEOM meeting to form a Product Working Group on Traditional Medicines and Health Supplements, which was approved. �M$s�/\��-v��s�C��T�(��~�)��@��,��0@T�o�k��䰝�O��i�ghF=��ƛ2+�u5y~��kR��r�A��.R�.��^��V� %�� Singapore-Specific Annex (SSA) Template 424 KB; 17. 2 0 obj Herbal drugs and preparations are classified in their entirety like the Active Pharmaceutical Ingredient (API) in the HMP. As a consequence, several countries and regions 103 have revised their own stability testing guidelines, defining up to 104 30°C/75% RH as the long-term storage conditions for hot and humid 105 regions. 1 Version 1 ຍIຈຌ ຳ ນົັກກາຌກາຌຏະຖຈິ຋ໃີຈີ(Good Manufacturing Practice (GMP)) ຽຎັຌບ຺ຄຎະກບຍ The European Medicines Agency's scientific guidelines on the stability of drug substances and drug products help medicine developers prepare marketing authorisation applications for human medicines.. For a complete list of scientific guidelines currently open for consultation, see Public consultations. As indicated by a new study by Future Market Insights (FMI), the market is driven by the rising importance being given to preventive healthcare practices, and the expansion of the global geriatric population. Country’s registration / listing / notification number (if applicable) The combination of numbers, symbols and letters assigned to the health supplements which is approved by the National Regulatory Authority (NRA) shall be declared, if applicable. -Stability Requirements in the drug development process. There are 10 Guidelines of the ASEAN RAI. These guidelines are adapted from the World Health Organization (WHO) guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products. <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 595.32 842.04] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> This guidance document is intended to provide direction to support stakeholders in assuring that natural health products (NHPs) are produced in a high quality manner, and to set out how an applicant or licencee can establish an acceptable level of compliance to the Natural Health Products Regulations (NHPR), as it relates to the quality requirements for NHPs. William Morkel, BSc Senior Quality Assurance and Regulatory Affairs Specialist, dicentra Inc. For the purpose of clarity, this ASEAN Alliance of Health Supplement Associations (AAHSA) The Association of Southeast Asian Nations (ASEAN) was created in 1967 with the signing of the ASEAN Declaration by Indonesia, Malaysia, Philippines, Singapore and Thailand. Facilitating trade in safe and quality health supplement products for the … INTRODUCTION This guideline applies to the traditional medicine and health supplement products to Guideline on summary of product characteristics (SmPC) Declaration of storage conditions for medicinal products particulars and active substances (Annex) Development pharmaceutics; ICH Q1A (R2) Stability testing of new drug substances and drug products; ICH Q1E Evaluation of stability data for health supplements. Guideline for Industry – The Stability Testing of Cosmetics. Colipa/CTFA Guidelines on Stability Testing of Cosmetic Products, March 2004 [8] WHO. endstream WHO Technical Report Series. stream Understand the regulations on health supplements and permissible health claims before you import, sell or manufacture them in Singapore. The Traditional Medicines and Health SupplementsProduct Working Group (TMHS PWG) is tasked to work on the following measures under the ASEAN Economic Community Blueprint by 2015, namely: Implementation of harmonised technical requirements on product placements requirements, including safety, efficacy and stability guidelines and harmonised technical requirements on labeling … As a consequence, several countries and regions 103 have revised their own stability testing guidelines, defining up to 104 30°C/75% RH as the long-term storage conditions for hot and humid 105 regions. <>>> The recommended stability tests parameters for different dosages forms should be considered in line with ASEAN stability guidelines. 1.1. This Guideline is broadly based on ASEAN Guidelines for regulation of Health Supplements. Requirements for Registration of Dietary Supplements in ASEAN Countries10 INTRODUCTION This guideline applies to the traditional medicine and health supplement products to ensure the safe and effective use of traditional medicines and health supplements among consumers and facilitate registration process among ASEAN member states. Annex VI – ASEAN Guiding Principles on Safety Substantiation for Traditional Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements Posted By Jauze 01 January 2008 3 0 obj The Guidelines should be used in conjunction with the ASEAN Guidelines for Good Manufacturing Practice for Food The Product Working Group for Traditional Medicines and Health Supplements (TMHSPWG) was established under the umbrella of ASEAN Economic Community (AEC) in 2004. ��zЍ��X��}F�n��H�_Q�BQ��,SKӵ9��I�g�W��/c%Ջ��Qj�(�6�T��p��q�:�V��Sx8gh*WS翪�/�&��_�?��Y��m'0��h�A��l�M��0�F��D��w{�� ʖ�-w'[ The primary purpose of the Guidelines is to promote investment in food, agriculture - including fisheries and forestry in the ASEAN region that contributes to regional economic development, food and nutrition security, food safety and equitable benefits, as well as the sustainable use of natural resources. The primary objective of GMP is to ... using measures other than those described in these guidelines. ASEAN Guidelines on Stability and Shelf-Life of Traditional Medicines and Health Supplements -Provide recommendations for conducting a stability study on TMHS and its shelf-life. APPENDIX 4: GUIDELINE ON REGISTRATION OF HEALTH SUPPLEMENTS Outline: 4.1 Definition 4.1.1 Health Supplement (HS) 4.1.2 Indication 4.1.3 Route of Administration 4.1.4 Exclusion as Health Supplement 4.1.5 Exemption 4.2 Active Ingredients 4.3 Maximum Daily Levels of Vitamins and Minerals for Adults Allowed in Health Supplements 2. ASEAN AGREEMENT ON HEALTH SUPPLEMENTS The Governments of Brunei Darussalam, the Kingdom of Cambodia, ... ASEAN Guidelines on Stability and Shelf-Life of Health Supplements; f) Annex VI – ASEAN Guiding Principles on Safety Substantiation for Health Supplements; ASEAN integration For a single market By 2015 Health care sector: services and products Products: medicines, devices, traditional medicines, health supplements, cosmetics 3. ",#(7),01444'9=82. <> Report adverse events. endobj <> HSA is the national authority regulating health products; managing the national blood bank, transfusion medicine and forensic medicine expertise; and providing … away from dusty roads, garbage dump, pollution sources and other potential sources of contamination such as Version 1.0-26/5/2014 Page 1 ASEAN GUIDELINES ON LABELING REQUIREMENTS FOR TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS 1. Substances not allowed Substances not allowed. asean guidelines on good manufacturing practice . 1 0 obj Association of South East Asian Nations (ASEAN) ANNEX VIII - ASEAN GUIDELINES ON GOOD ... 1 Version 1 INTRODUCTION Good Manufacturing Practice (GMP) is an essential component in the manufacture of Health supplements (HS). It also promotes proper storage and logistic condition. -Factor that affects stability profile of drug products.-Compare stress testing requirements.-WHO Stability Program requirements.-Requirements in batch selection and container-closure system.-Understand Significant Change of ASEAN guidelines.-Stability protocol and study set up. ASEAN (2005) ASEAN guidelines on stability and shelf-life of traditional medicines and health supplements. Confirmation of Quality Dossiers with Reference Agency's Approval 357 KB. ASEAN Alliance of Health Supplement Associations (AAHSA) Following the meeting of the ACCSQ TMHS PWG in 2006, the ACCSQ TMHS PWG Scientific Committee (ATSC) was created to assist the TMHS PWG in the study of additional areas for harmonization of traditional medicines and health supplements and provide scientific information and recommendations on the following areas of … Working document QAS/17.694 page 3 Introduction and background36 37 38 The Stability testing of active pharmaceutical ingredients and finished 39 pharmaceutical products was published as Annex 2 in the WHO Technical 40 Report Series, No. �@�3(*In/��9[�Ȗn��/�t ��|گ��=�ή�:'�zo��Ï��9K�� The Guidelines are voluntary in nature, but primarily aim to guide ASEAN Member States to enact binding laws and regulations. These Guidelines define the: a. ASEAN Harmonization on Traditional Medicine and Health Supplement Registration Requirement N. BUNYAPRAPHATSARA. Currently, each ASEAN Member States have different standards and requirements for permitted health supplement ingredients and levels. In addition to policymakers, agribusiness investors, financial institutions, have essential roles to play.. Health Supplements contain one or more, or combination of the following ingredients i. Stability Data 13. Brunei Darussalam then joined in 1984, Viet Nam in 1995, Lao PDR and Myanmar in 1997, and Cambodia in 1999, arriving at the current number of ten … The “Guideline for regulating Health Supplements” is formulated to assist the ... Annex V – ASEAN Guidelines on Stability and Shelf-Life of Traditional Medicines and Health Supplements; vi. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements - 2015 Chapter 3 Premises and Equipment 17 Premises shall be located at a suitable site approved by the relevant authorities. endobj Refer to the ASEAN website (click on "POLICY & GUIDELINES" to expand the section and refer to point 11) for the following ASEAN Guidelines developed by the TMHS PWG: HSA has developed the following guidance for the industry to address frequently asked questions (FAQ) on the ASEAN Guidelines: Bringing personal medications into Singapore, âControlled drugs and psychotropic substances, âRegistration guides for therapeutic products, Free Sales Certificate and Export Certificate, Bringing personal medical devices into Singapore, COVID-19: Standards Resources for Essential Medical Devices, Fees and Turnaround time of Chinese Proprietary Medicines, Good Manufacturing Practice certification for cosmetic products, Tobacco retailer educational video and quiz, Regulations for bringing in personal medications, Guidance for suppliers of hand sanitisers, Good Distribution Practice for Medical Devices, Summary Reports of Benefit-Risk Assessment, GMP conformity assessment of overseas manufacturers, Preparations allowed as General Sale List, Good Manufacturing Practice and Good Distribution Practice Standards, Handling of Applications and Conduct of Inspections During COVID-19, Renew or cancel a retail pharmacy licence, Supply of registered therapeutic products through e-pharmacy, Apply for a Chinese Proprietary Medicine dealer's licence, Amend a Chinese Proprietary Medicine dealer's licence, Good Manufacturing Practice and Good Distribution Practice, Import for re-export of Chinese Proprietary Medicines, âInvestigational and auxiliary products, Amend licence to wholesale or manufacture controlled drugs, Class D with a registrable drug in a secondary role full registration, Class D with registrable drug in secondary role abridged registration, Fluorescence in situ hybridisation (FISH) probes IVD, Import for re-export of unregistered devices, Unregistered devices for non-clinical purposes, Registered medical devices on consignment basis, Unregistered devices requested by qualified practitioners, Unregistered devices requested by licensed PHMC, Import of unregistered medical devices for exhibition, Import and supply of unregistered TP for patient's use, Import and supply of registered drug on consignment basis, Special consignment by a product registrant, Pandemic Special Access Route for Supply of Emergency TP, Full evaluation route for MAV-1 application, Abridged evaluation route for MAV-1 applicationâ, Verification evaluation route for MAV-1 application, Good Manufacturing Practice certificate for local manufacturers, Good Distribution Practice certificate for local dealers, Apply for tobacco import and wholesale licence, Amend tobacco import and wholesale licence, Renew tobacco import and wholesale licence, Cancel tobacco import and wholesale licence, International collaboration for complementary health products, ASEAN cooperation on standards and conformance to facilitate trade in the region, FAQ on ASEAN Guidelines for Minimising the Risk of Transmission of Transmissible Spongiform Encephalopathies in Traditional Medicines and Health Supplements, FAQ on ASEAN Guiding Principles for the Use of Additives and Excipients in Traditional Medicines and Health Supplements, FAQ on ASEAN Guiding Principles on Safety Substantiation of Traditional Medicines and Health Supplements, FAQ on ASEAN Guidelines on Claims and Claims Substantiation for Traditional Medicines and Health Supplements, Implementing measures for the integration of traditional medicines and health supplements stipulated in ASEAN Healthcare Integration Roadmap, Harmonising technical requirements and explore possible Mutual Recognition Arrangements. 10. 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