Regulatory Updates
Consultation paper – Proposed quality standards for MDMA and psilocybin
Distribution date: 18 December 2023 | Final date for Comment: 31 January 2024
The Therapeutic Goods Administration (TGA) administers Australia’s national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods in Australia. There are provisions under the Therapeutic Goods Act 1989 to establish quality standards for therapeutic goods. These standards, known as TGOs, can specify things such as procedures to be carried out in the manufacture of the goods, labelling, or other requirements. Once approved, TGOs are registered as legislative instruments on the Federal Register of Legislation in Australia. The TGA has developed two new quality standards that will be registered as legislative instruments on the Federal Register of Legislation in Australia as Therapeutic Goods Orders (TGOs):Standard for MDMA hydrochloride, and Standard for PsilocybinThe TGA is undertaking a public consultation between Friday 8 December 2023 to Wednesday 31 January 2024 to seek feedback on the appropriateness of the requirements in the TGOs. Until 1 July 2023 Australian patients only had access to therapy with ,4‑methylenedioxy‑N-methylamphetamine hydrochloride (MDMA) and psilocybin as part of clinical trials. Effective from 1 July 2023, the TGA amended the Poisons Standard to add MDMA and psilocybin to Schedule 8 (S8), permitting their use as Controlled Drugs only for the treatment of post-traumatic stress disorder (PTSD) and treatment resistant depression (TRD), respectively. Only authorised medical practitioners are permitted to prescribe S8 MDMA and psilocybin.There are no quality standards such as pharmacopoeial monographs or TGOs for MDMA or psilocybin. The TGA has developed manufacturing and testing requirements that will form the basis of proposed new TGOs for each of these medicines.
Products Covered: Medicines
Regulation Type: Regular notification
Consultation paper – Proposed quality standards for MDMA and psilocybin
Distribution date: 18 December 2023 | Final date for Comment: 31 January 2024
The Therapeutic Goods Administration (TGA) administers Australia’s national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods in Australia. There are provisions under the Therapeutic Goods Act 1989 to establish quality standards for therapeutic goods. These standards, known as TGOs, can specify things such as procedures to be carried out in the manufacture of the goods, labelling, or other requirements. Once approved, TGOs are registered as legislative instruments on the Federal Register of Legislation in Australia. The TGA has developed two new quality standards that will be registered as legislative instruments on the Federal Register of Legislation in Australia as Therapeutic Goods Orders (TGOs):Standard for MDMA hydrochloride, and Standard for PsilocybinThe TGA is undertaking a public consultation between Friday 8 December 2023 to Wednesday 31 January 2024 to seek feedback on the appropriateness of the requirements in the TGOs. Until 1 July 2023 Australian patients only had access to therapy with ,4‑methylenedioxy‑N-methylamphetamine hydrochloride (MDMA) and psilocybin as part of clinical trials. Effective from 1 July 2023, the TGA amended the Poisons Standard to add MDMA and psilocybin to Schedule 8 (S8), permitting their use as Controlled Drugs only for the treatment of post-traumatic stress disorder (PTSD) and treatment resistant depression (TRD), respectively. Only authorised medical practitioners are permitted to prescribe S8 MDMA and psilocybin.There are no quality standards such as pharmacopoeial monographs or TGOs for MDMA or psilocybin. The TGA has developed manufacturing and testing requirements that will form the basis of proposed new TGOs for each of these medicines.
Products Covered: Medicines
Regulation Type: Regular notification
Revision of the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA)
Distribution date: 18 December 2023 | Final date for Comment: 22 March 2024
The Therapeutic Products Act, which has been in force since 2002, is currently being revised . Topics which are affected:Advanced therapy medicinal products (ATMPs)Digitalisation in the prescription, dispensing and use of therapeutic productsVeterinary medicinal productsSwiss law is harmonised with EU law in order to reduce technical barriers to trade. The proposed changes are intended to bring greater clarity and certainty to the authorisation of advanced therapy medicinal products (ATMPs). In the area of veterinary medicinal products, a legal basis is created to prohibit the use of certain antimicrobial medicinal products (prevention of antibiotic resistance), to authorise innovative therapies and to permit authorisations to be valid for an unlimited period.
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); Generalities. Terminology. Standardization. Documentation (ICS code(s): 01); Natural and applied sciences (ICS code(s): 07); Health care technology (ICS code(s): 11)
Regulation Type: Regular notification
Revision of the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA)
Distribution date: 18 December 2023 | Final date for Comment: 22 March 2024
The Therapeutic Products Act, which has been in force since 2002, is currently being revised . Topics which are affected:Advanced therapy medicinal products (ATMPs)Digitalisation in the prescription, dispensing and use of therapeutic productsVeterinary medicinal productsSwiss law is harmonised with EU law in order to reduce technical barriers to trade. The proposed changes are intended to bring greater clarity and certainty to the authorisation of advanced therapy medicinal products (ATMPs). In the area of veterinary medicinal products, a legal basis is created to prohibit the use of certain antimicrobial medicinal products (prevention of antibiotic resistance), to authorise innovative therapies and to permit authorisations to be valid for an unlimited period.
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); Generalities. Terminology. Standardization. Documentation (ICS code(s): 01); Natural and applied sciences (ICS code(s): 07); Health care technology (ICS code(s): 11)
Regulation Type: Regular notification
Draft Commission Delegated Regulation amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include nitrogen generated from ambient air as an active substance in Annex I thereto
Distribution date: 18 December 2023 | Final date for Comment: 16 February 2024
This draft Commission Delegated Regulation amends Regulation (EU) No 528/2012 of the European Parliament and of the Council to include nitrogen generated from ambient air as an active substance in Annex I thereto.
Products Covered: Biocidal products
Regulation Type: Regular notification
Draft Commission Delegated Regulation amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include nitrogen generated from ambient air as an active substance in Annex I thereto
Distribution date: 18 December 2023 | Final date for Comment: 16 February 2024
This draft Commission Delegated Regulation amends Regulation (EU) No 528/2012 of the European Parliament and of the Council to include nitrogen generated from ambient air as an active substance in Annex I thereto.
Products Covered: Biocidal products
Regulation Type: Regular notification
Amendment to the List of Ingredients Prohibited in Cosmetic Products (Draft)
Distribution date: 15 December 2023 | Final date for Comment: 13 February 2024
The Food and Drug Administration (FDA) proposes to revise the list of ingredients prohibited in cosmetic products. Details of the regulated scope are specified in the attached documents.
Products Covered: Cosmetics; ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS 33)
Regulation Type: Regular notification
Amendment to the List of Ingredients Prohibited in Cosmetic Products (Draft)
Distribution date: 15 December 2023 | Final date for Comment: 13 February 2024
The Food and Drug Administration (FDA) proposes to revise the list of ingredients prohibited in cosmetic products. Details of the regulated scope are specified in the attached documents.
Products Covered: Cosmetics; ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS 33)
Regulation Type: Regular notification
Draft resolution number 734, 22 October 2019.
Distribution date: 15 December 2023
The Draft resolution number 734, 22 October 2019 - previously notified through G/TBT/N/BRA/929 - which proposes the updating of the Resolution 36, 26 August 2015, which establishes the risk classification, control scheme of notification, registration, market authorization and technical requirements for labelling and usage instructions of medical devices for in vitro diagnosis, was adopted as Resolution 830, 6 December 2023. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/5673188/RDC_830_2023_.pdf/0dcc96d1-7bfa-4a01-9e33-69676fd1eba9
Products Covered: HS Code(s): 3002300, 3822 (In vitro diagnosis products)
Regulation Type: Addendum to Regular Notification
Draft resolution number 734, 22 October 2019.
Distribution date: 15 December 2023
The Draft resolution number 734, 22 October 2019 - previously notified through G/TBT/N/BRA/929 - which proposes the updating of the Resolution 36, 26 August 2015, which establishes the risk classification, control scheme of notification, registration, market authorization and technical requirements for labelling and usage instructions of medical devices for in vitro diagnosis, was adopted as Resolution 830, 6 December 2023. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/5673188/RDC_830_2023_.pdf/0dcc96d1-7bfa-4a01-9e33-69676fd1eba9
Products Covered: HS Code(s): 3002300, 3822 (In vitro diagnosis products)
Regulation Type: Addendum to Regular Notification
Submit your email ID to receive notifications about upcoming courses and events
