Summary of APSMI Country Report 2019 0 Contents Introduction…………………………………………………………………………… 2 I. Summary of OTC Regulation in Member Countries………………………. 3 II. Activities to Promote Self-Medication by Member Associations…………11 III. OTC Market in Asia-Pacific Region…………………………………………..23 Annex 1: Dossier Requirements for OTC Registration Annex 2: Rx-to-OTC Switch Products in Member Countries Annex 3: New and Amended Regulation from 2016 to 2019 in Member Countries 1 Introduction Thanks to the contributions by its member associations and magnanimous provision of the market analysis by Nicholas Hall, Asia-Pacific Self-Medication Industry (APSMI) compiled the APSMI Country Report 2019 in October 2019. The Report was published on the occasion of the 12th Global Self-Care Federation Asia-Pacific Regional Conference & 4th APSMI General Assembly held in Beijing, October 2019, made available to the meeting participants and the APSMI members. The Report outlines the OTC regulations and the activities to promote self- medication in APSMI member countries; i.e. China, Chinese Taipei, Indonesia, Japan, Korea, and Thailand. It also includes analyses of global and Asian OTC markets as well national markets in the region. Though the access to the full Report remains to be the members’ privilege, APSMI has decided to publish its summary to the open public. The APSMI sincerely hopes that the information contained in the Summary Report will contribute to the OTC market growth, harmonization of OTC regulation, and promoting self-medication in the region. APSMI Secretariat November 2019 2 I. Summary of OTC regulations in member countries -Notes – The description of each country is simplified for the ease of comparison. 3 1. Category of drugs (OTC and Prescription and others?) China OTC and Rx. Herbal medicines are classified into OTC or Rx. OTCs are subcategorized with regard to allowable sales route. Some are general sales line items. Chinese OTC, RX and Traditional Chinese Drugs. OTCs are Taipei subcategorized into Pharmacy-only and general sales drugs. Indonesia OTC and Rx. Herbal medicines form another category different from OTC or Rx. OTCs are subcategorized with regard to allowable sales route. Some are general sales line items. Japan OTC and Rx. Herbal medicines are classified into OTC or Rx. OTCs are subcategorized with regard to allowable sales route. Korea OTC and Rx. Except for little exception, OTCs are sold only at pharmacies. Philippines OTC and Rx. Herbal medicines form another category. OTCs are sold only at pharmacies. Thailand Rx, Modern OTC, and Traditional OTC. OTCs are subcategorized into drug store-only and general sales drugs. 2. Abridged approval applications (for e.g. OTC with precedents, monograph- compatible OTCs, etc.) China Full application only. There is no difference in required data between Rx and OTC. Chinese Abbreviated applications for switch OTC and monographs- Taipei compatible OTCs Indonesia Abbreviated applications for drugs with precedents. Japan Abbreviated applications for switch OTC and monographs- compatible OTCs Korea Abbreviated applications for switch OTC and monographs- compatible OTCs Philippines Abbreviated applications for switch OTC and monographs- compatible OTCs Thailand No abbreviated application for OTC. OTC applications follow the guidelines for new drugs or generic drugs. 3. Review track /Review department specially for OTCs 4 China The authority has no specially designated review track or review department for OTC. Approval application for OTC is reviewed not differently from new drugs. Chinese The authority has no specially designated review track or review Taipei department for OTC. Approval application for OTC is reviewed not differently from new drugs. Indonesia The authority has specially designated review track and review department for OTC. Japan The authority has specially designated review track and review department for OTC. Korea The authority has no specially designated review track or review department for OTC. Approval application for OTC is reviewed not differently from new drugs. Philippines The authority has no specially designated review track or review department for OTC. Approval application for OTC is reviewed not differently from new drugs. Thailand The authority has no specially designated review track or review department for OTC. Approval application for OTC is reviewed not differently from new drugs. 4. Regulatory permission on Advertisement of OTC to the general public China Need of regulatory permission for advertisement in all media (TV, Radio, Internet, Printed materials). Chinese Need of regulatory permission for advertisement in all media Taipei (TV, Radio, Internet, Printed materials). Indonesia Need of regulatory permission for advertisement in all media (TV, Radio, Internet, Printed materials). Japan No regulatory permission is needed. But the Japanese OTC industry has self-imposed guideline on advertisement as well as a committee to survey member companies’ advertisements as to their adherence to the guidelines and to recommend rectification when there are any violations. Korea Need of regulatory permission for advertisement in all media (TV, Radio, Internet, Printed materials). Philippines Need of regulatory permission for advertisement in all media (TV, Radio, Internet, Printed materials). 5 Thailand Need of regulatory permission for advertisement in all media (TV, Radio, Internet, Printed materials). 5. Regulatory permission on revising labelling of OTCs China Necessary Chinese Necessary Taipei Indonesia Necessary Japan Necessary, but only for the essential part on the drug’s indication, dosage, and caution on use. Other parts to provide information of more promotional nature can be revised without permission. Korea Necessary Philippines Necessary Thailand Necessary 6. Standards and Guidelines applicable to OTC drugs (1) GMP China GMP applied to OTC is aligned to PIC/S GMP Chinese GMP applied to OTC is aligned to PIC/S GMP Taipei Indonesia GMP applied to OTC is aligned to PIC/S GMP Japan GMP applied to OTC is aligned to PIC/S GMP Korea GMP applied to OTC is aligned to PIC/S GMP Philippines GMP applied to OTC is aligned to PIC/S GMP Thailand GMP applied to OTC is aligned to PIC/S GMP (2) Pharmacopoeia China The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees. Chinese The authority applies its domestic pharmacopoeia to OTC. Other Taipei countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees. Indonesia The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees. 6 Japan The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees. Korea The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees. Philippines The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees. Thailand The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees. (3) ICH guidelines applicability i. Q1, 3, 6, 7 China Basic ICH Q Guidelines (Q1, Q3, Q6, and Q7) are generally applicable to both Rx and OTC. Chinese Basic ICH Q Guidelines (Q1, Q3, Q6, and Q7) are generally Taipei applicable to both Rx and OTC. Indonesia Basic ICH Q Guidelines (Q1, Q3, Q6, and Q7) are generally applicable to both Rx and OTC. Japan All ICH Q Guidelines are applicable to RX and direct OTC (new chemical entity approved first as OTC). Other OTC are exempted from application of ICH guidelines but subject to simpler domestic guidelines. Korea Basic ICH Q Guidelines (Q1, Q3, Q6, and Q7) are generally applicable to both Rx and OTC. Philippines Basic ICH Q Guidelines (Q1, Q3, Q6, and Q7) are generally applicable to both Rx and OTC. Thailand Relevant ASEAN guidelines apply. ICH Guidelines are used as reference. Q1 : Stability Q3: Impurities Q6 : Specifications Q7 : GMP for Active Pharmaceutical Ingredients ii. S4 (Chronic Toxicity Testing) 7 China S4 Guideline is applicable to both Rx and OTC. Chinese S4 Guideline is applicable to OTC that is new drugs (direct Taipei OTC). Indonesia S4 Guideline is not applicable to OTC. Japan All ICH S Guidelines are applicable to RX and direct OTC (new chemical entity approved first as OTC). Other OTC are exempted from application of ICH guidelines but subject to simpler domestic guidelines. Korea S4 Guideline is applicable to OTC. Philippines S4 Guideline is applicable to OTC. Thailand S4 Guideline is applicable to OTC. iii. E2B, E2D, E6 China E2B, E2D, E6 are all applicable to Rx and OTC. Regarding ADR reporting, OTC and Rx undergo the same regulation. Chinese E2B, E2D, E6 are all applicable to Rx and OTC. Regarding ADR Taipei reporting, OTC and Rx undergo the same regulation. Indonesia E2D and E6 are all applicable to OTC. Japan E2B, E2D, E6 are all applicable to Rx and OTC. Regarding ADR reporting, OTC and Rx undergo the same regulation. Korea E2B, E2D, E6 are all applicable to Rx and OTC. E2B is partly applicable. Philippines E2B, E2D, E6 are all applicable to Rx and OTC. Thailand E6 Applies to OTC. E2B and E2D are not implemented in Thailand (for Rx or OTC). E2B : Individual Case Safety Reports E2D : Standards for Expedited Reporting E6 : Good Clinical Practice iv. M1 and M4 China Pilot of M1 and China CTD (similar to M4) are implemented. Chinese M1 and M4 are applicable to OTC. Taipei Indonesia M1 and M4 are applicable to OTC. Japan M1 is applicable to both Rx and OTC. M4 is applicable to direct OTC. Other types of OTC are exempted from M4 application. Korea M1 is being applied to OTC in stages. M4 is not applicable to OTC. Philippines M1 is not applicable to OTC. M4 is applicable to OTC. 8 Thailand M1 and M4 are not applicable to OTC.