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International Over-The-Counter (OTC) Medicines Regulators Forum
On the margin of the World Self-Medication Industry (WSMI) General Assembly, TGA hosted the International OTC Medicines Regulators Forum in Sydney.
The first session of the Forum took place on 19 October 2017 and was open to conference delegates and members of the public with an interest in regulatory issues in relation to non-prescription medicines. On 20 October 2017, regulators from sixteen countries attended a closed session of the Forum. The Forum provided a platform to exchange ideas and share experiences, and fostered closer collaboration and a deeper understanding of issues of mutual interest.
The following are the presentations from the two days of the Forum.
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- United Kingdom: UK incentives with regards to switching - Dr Jan MacDonald, Medicines and healthcare Regulatory Agency (MHRA), UK (pdf,242kb)
- Ireland: The search for switch candidates - the Irish experience - Ms Lorraine Nolan, Health Products Regulation Agency (HPRA), Ireland (pdf,1.25Mb)
- Singapore: Adoption of a proactive approach towards reclassification of medicines in the Singaporean context - Mr Mark Wong, Health Sciences Authority (HSA), Singapore (pdf,535kb)
- Canada: The Canadian experience - reforms to the regulation of self-care products - Mr Matthew Bown, Health Canada, Canada (pdf,350kb)
- South Africa: o South Africa's experience on the regulatory framework of OTC medicines - Dr Neil Gower, Medicines Control Council (MCC), South Africa (pdf,426kb)
- Colombia: Encouraging consumer health literacy about OTC medicine use - Dr Javier Humberto Guzman Cruz, The National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamento (INVIMA), Colombia (pdf,1.04Mb)
- New Zealand: NZ's criteria for switching and how we mitigate risks associated with broadening access - Mr Chris James, New Zealand Medicines and Medical Devices Safety Authority (Medsafe), New Zealand (pdf,200kb)
- Germany: Risk mitigation when switching - Germany's experience within the wider European perspective - Dr Martin Huber, Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), Germany (pdf,375kb)
- Switzerland: Switzerland's current reclassification experience and how to mitigate inherent risks - Dr Claus Bolte, The Swiss Agency for Therapeutic Products (Swissmedic) (pdf,1.25Mb)
- United Kingdom: Pharmacy only vs pharmacist only (BTC) access: When is self-selection the right approach? - Dr Jan McDonald, Medicines and healthcare Regulatory Agency (MHRA), UK (pdf,417kb)
- Malaysia: How OTC drugs are regulated in Malaysia - Ms Suhailah Abu Bakar, National Pharmaceutical Regulatory Agency (NPRA), Malaysia (pdf,799kb)
- Taiwan: Regulation of boundary products in Taiwan - Dr Shirley Pan, Taiwan Food and Drug Administration (TFDA), Taiwan (pdf,2.11Mb)
- Japan: Self-CARER (Self-medication Collaborative ASIAN Regulator Experts Roundtable) - Dr Kazushige Murayama, Pharmaceuticals and Medical Devices Agency (PMDA), Japan (pdf,206kb)
- United States of America: The FDA monograph approach - Dr Theresa Michele, US Food and Drug Administration (USFDA), United States (pdf,1.32Mb)
- Australia: The experience in Australia - Dr Mayada Kayali, Department of Health, Australia (pdf,281kb)
- Australia: The Australian Review of Medicines and Medical Devices Regulation - stakeholder consultation on options for the advertising of OTC and complementary medicines - Dr Mark McDonald, Department of Health, Australia (pdf,295kb)